MASiMO PLM-14346A Pulse Oximetry and Skin Pigmentation User Guide

MASiMO PLM-14346A Pulse Oximetry and Skin Pigmentation

Product Information

Masimo Pulse Oximetry is a medical-grade device that measures blood oxygen saturation levels (SpO2) and pulse rate in real-time. The device is designed to be highly accurate and can be used on people with all skin pigmentations.

Supplemental Slides

The product comes with Supplemental Slides that provide additional information on the accuracy of Masimo Pulse Oximetry. The slides include an Executive Summary of the results of a laboratory study on racial effects on the device, as well as detailed study methods and participant demographics.

Study Results

The study found that the SpO2-SaO2 difference (bias) of 0.15% is not clinically significant. The device was highly accurate and can be used with assurance in people with all skin pigmentations.

Product Usage Instructions

1. Place the device on the fingertip of the patient and ensure a snug fit.
2. Press the power button to turn on the device.
3. The SpO2 and pulse rate will be displayed on the screen in real-time.
4. If necessary, adjust the position of the device on the patient’s finger for optimal readings.
5. Turn off the device after use by pressing the power button.

FDA Advisory Meeting

Masimo supports the FDA’s decision to convene an Advisory Meeting on Pulse Oximetry to discuss the real-world performance of pulse oximeters and factors impacting accuracy in diverse populations. Masimo believes that more stringent ARMS accuracy requirements and greater diversity of skin tones for validation studies should be implemented to improve regulatory oversight of pulse oximeter devices.

Background

The purpose of the following supplemental slides is to provide additional information on Masimo SET® performance in varying skin pigmentations.

Executive Summary

• Masimo invented Measure-through Motion and Low Perfusion™ pulse oximetry using Signal Extraction Technology® (SET®) over three decades ago to address these known pulse oximetry confounders.

• SET® also addresses skin pigmentation and other static absorbers such as skin thickness and bone density.
• Our data, detailed in the following slides, demonstrates that Masimo SET® pulse oximeters are equally accurate for individuals of all skin tones.
• Despite the currently excellent accuracy across all skin tones provided by Masimo SET®, we will continue to improve our accuracy and reliability.

Racial Effects on Masimo Pulse Oximetry: A Laboratory Study

• Barker SJ – Chief Science Officer and Wilson WC – Chief Medical Officer
• Retrospective analysis of Masimo SET® data
• Abstract presented at Society of Technology in Anesthesiology (STA) Annual Meeting in January 2022
• Full Manuscript in J Clin Monit Comput (published Nov. 12, 2022)
• Read the full study here: https://link.springer.com/article/10.1007/s10877-022-00927-w

Study Methods

• Data from volunteers October 2015 – July 2021
• Masimo SET® pulse oximeters with RD SET® sensors
• Volunteers underwent stepwise hypoxemia, with arterial SaO2 down to 70%
• SpO2 values time-matched with ABG samples within 5 seconds

Masimo

SET ®

|

N

|

Paired

Samples

| Age Mean range|

Sex

|

Massey

Scale

| tHb (g/dL) mean range| CoHb % mean range| MetHb

%

mean range

---|---|---|---|---|---|---|---|---
Black| 39| 3,201| 34.8

21-50

| 25M

14F

| 4-9| 14.5

11.3-18.2

| 1.1

0.3-1.8

| 1.1

0.3-1.6

White| 36| 3,982| 30.4

18-44

| 23M

13F

| 1-4| 14.5

11.2-18.1

| 0.9

0.3-1.6

| 1.1

0.3-1.5

All| 75| 7,183| 32.7

18-50

| 48M

27F

| 1-9| 14.5

11.2-18.2

| 1.0

0.3-1.8

| 1.1

0.3-1.6

Study Participant Skin Color Distribution Histogram

Massey-Martin Scale by Self-identified Race

SpO2-SaO2 Results

Occult Hypoxemia Results: Sjoding vs. Masimo

(Box Plots in 1% Bins)

Study Conclusions

• The SpO2-SaO2 difference (bias) of 0.15% is not clinically significant because 0.15 is approximately 1/7 of 1% and the SpO2 display resolution on all pulse oximeters is 1%.
• There was no clinically significant difference in the accuracy or bias between Black and White subjects monitored with Masimo SET® pulse oximetry and RD SET sensors.
• Masimo RD SET is highly accurate and can be used with assurance in people with all skin pigmentations.

FDA Advisory Meeting

• Masimo applauds the FDA’s decision to convene an Advisory Meeting on Pulse Oximetry on November 1, 2022 to discuss the real-world performance of pulse oximeters and factors impacting accuracy in diverse populations.
• The information provided is under consideration by the FDA in their deliberations on improving regulatory oversight of pulse oximeter devices.

Masimo’s Call to Action

As a key contributor to this panel, Masimo believes that it is in the public interest to implement the following policies for gaining 510(k) clearance of medical-grade pulse oximeters:

• More stringent ARMS accuracy requirements.
• Greater diversity of skin tones for validation studies. The current FDA guidance calls for a minimum of 2 subjects or 15% of the study pool (whichever is larger).
• More rigorous skin pigmentation benchmarks. For example, a validated skin pigment categorization such as the MasseyMartin Scale, as well as quantitative measures (e.g. spectrophotometric skin tone assessment), should be used to ensure skin tone diversity in data.

Conclusion

• Masimo is currently pursuing prospective clinical studies to a) confirm our laboratory data showing excellent accuracy across all skin tones and b) continue to improve both accuracy and reliability.
• There is abundant evidence that non-medicalgrade pulse oximeters are being purchased and used for medical decision-making outside of the hospital, which should be regulated.
• All pulse oximeters should be required to meet the same minimum accuracy requirements as current medical-grade pulse oximeters.

Visit www.masimo.com/rd-set-sensors to learn more about RD SET sensor.
For professional use. See instructions for use for full prescribing information including indications, contraindications, warnings and precautions.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

References

• Racial effects on Masimo pulse oximetry: a laboratory study | SpringerLink
• Racial effects on Masimo pulse oximetry: a laboratory study | SpringerLink

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