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The Masimo Disposable Transflectance Forehead Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Masimo Disposable Transflectance Forehead Sensors are intended for use with adult and pediatric patients, weighing greater than 10 kg, who are well or poorly perfused in healthcare environments.

The subject device, Masimo Disposable Transflectance Forehead Sensor (Forehead Sensor), is a single-use sensor and is supplied non-sterile. The sensor is available in two configurations, consisting of the LNCS TFA-1 with the DB9 sensor connector and the M-LNCS TFA-1 with the M15 sensor connector. The different sensor connectors allow for sensor connection to instruments with corresponding mating DB9 or M15 connectors. The subject device shall also be available with RD sensor connector. The subject device is intended to be used with instruments that include Masimo SET technology for the monitoring of:

• Functional Oxygen Saturation of Arterial Hemoglobin (SpO2): The amount of oxyhemoglobin expressed a percentage of the hemoglobin that is available
• Pulse Rate (PR): Measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse
• Perfusion Index (PI): The ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue
• Pleth Variability Index (PVI): Measure of dynamic changes in perfusion index that occur during the respiratory cycle.

Here's a breakdown of the acceptance criteria and study information for the Masimo Disposable Transflectance Forehead Sensor based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

*ARMS (accuracy root mean square) per ISO-80601-2-61.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a specific number of subjects for the clinical accuracy study. The document mentions "healthy adult volunteers with light to dark skin pigmentation." However, it does state that the "variation in the accuracy specifications equals plus or minus one standard deviation, which encompassed approximately 68% of the tested population." This implies a sufficiently large sample to calculate a standard deviation for clinical accuracy, but the exact number isn't provided.
• Data Provenance: The study was clinical and conducted by the manufacturer, Masimo Corporation. It involved "healthy adult volunteers." The location of these volunteers (e.g., country of origin) is not specified. The study appears to be prospective as it involved applying the sensors and taking measurements from volunteers.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for SpO2 measurements was established using a laboratory CO-oximeter for arterial blood samples, not human experts.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on objective laboratory measurements (CO-oximeter), not expert opinions requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a sensor for pulse oximetry, and its performance is evaluated against objective physiological measurements, not through human reader interpretation of images or data.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The document describes clinical performance testing where "The Forehead Sensors, connected to MX technology boards with Masimo SET technology, were applied to healthy adult volunteers...SpO2 measurements were compared against arterial blood samples analyzed by a laboratory CO-oximeter, in the range of 70 to 100%, to determine accuracy specifications." This describes the algorithm's (Masimo SET technology) performance in conjunction with the sensor independently.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was objective laboratory measurements from a CO-oximeter analyzing arterial blood samples.

8. The Sample Size for the Training Set

The document does not provide information about a training set size. This is a medical device, and the "Masimo SET technology" refers to the underlying algorithm for pulse oximetry measurements. The document outlines verification and validation of the sensor and the expected accuracy of the associated technology, but does not detail the development or "training" of a machine learning algorithm in the way that would typically be described for AI software.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a training set and its ground truth in the context of a machine learning algorithm are not described for this device. The "Masimo SET technology" is pre-existing and forms the basis of the oximeter's function, with the sensor being a component validated for use with this technology.

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