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The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40 kg.

When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in pediatrics ≥ 5 kg and < 40 kg.

When used with the O3 Neonatal Sensor, the O3 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) in neonates < 10 kg.

The Masimo Regional Oximetry System monitors regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System includes the O3 Sensors that acquire physiological signals and the O3 Module that processes those signals. The FDA has previously cleared the O3 System in K160526 (with an O3 Adult Sensor) and K162603 (with an O3 Pediatric Sensor). In this submission, Masimo seeks clearance of its O3 System with an 03 Neonatal Sensor.

Similar to the cleared O3 Adult and Pediatric Sensors, the O3 Neonatal Sensor is a singlepatient use, adhesive sensor and is supplied non-sterile. The O3 Neonatal Sensor attaches to the patient's forehead. The sensor includes four emitters and two detectors. The emitters radiate multiple wavelengths of near infrared light, while the detectors sense the reflected light. The detector outputs are physiological signals and these signals pass through the other end of the sensor that connects to a patient cable, passing these signals to the O3 Module for processing.

The O3 Module is unchanged from K160526. It includes Masimo technology for processing those signals and outputting regional oximetry (tSO2) measurements. Specifically, the O3 Module includes Near Infra Red Spectroscopy (NIRS) technology. When O3 module is connected to an O3 Neonatal Sensor, the O3 Monitor continuously and accurately determines the trending measurement of regional blood oxygen saturation in the tissue (rSO2) in neonates. In turn, the Host/Backboard device displays this measurement. The O3 Module can connect to up to two O3 Sensors, both connected to a patient.

The O3 System does not have an internal battery or an AC power input. The O3 Module, instead, receives power via its connection to a Host/Backboard Device, such as the Root Monitoring System (Root). Root in turn receives power from either AC power or internal rechargeable batteries.

Similar to K160526, the O3 System using an O3 Neonatal Sensor provides the following key measurements:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site, including cerebral tissue
• Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the userdefined rSO2 low alarm limit (LAL)
• . Delta SpO2 (4SpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

Here's an analysis of the acceptance criteria and study information for the Masimo O3 Regional Oximeter System, specifically focusing on the O3 Neonatal Sensor, based on the provided text:

Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter System (O3 Neonatal Sensor)

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on the "Reported Device Performance":

• For the display ranges and resolutions, the "Reported Device Performance" can be inferred to match the "Acceptance Criteria (Specification)" as these are direct specifications of the device.
• For Trending ARMS, the document states the specification is "3% for SavO2 of 45%-85%" and explains the methodology to determine this for the Neonatal sensor, but doesn't explicitly state "the study demonstrated the device met the 3% Trending ARMS." However, it's listed as a specification, so the implication is that the outcome of the calculation supports this specification.
• Absolute accuracy was not a claim but reported as a "convenience sample," indicating it's not a formal acceptance criterion for this submission's claims.

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

• Sample Size (Clinical Study for Trending ARMS): The text indicates a combined approach:
  • One clinical study for the O3 Adult Sensor to establish its trending accuracy with respect to blood testing (sample size not specified).
  • A separate study where relative rSO2 data was collected for both the O3 Adult Sensor and O3 Neonatal Sensor on the same subject to calculate the O3 Neonatal Sensor's Trending ARMS relative to the O3 Adult Sensor (sample size for this specific part is not provided).
• Sample Size (Clinical Study for Absolute Accuracy - convenience sample): 11 hospitalized patients.
• Data Provenance: The document does not specify the country of origin. The studies appear to be prospective clinical studies conducted by Masimo to support the device's performance claims.

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

• Not applicable / Not specified. The ground truth for this device's performance is established through direct physiological measurements (blood testing/SavO2), not through expert interpretation of images or other data that would require multiple human experts for ground truth establishment.

4. Adjudication Method for the Test Set:

• None. As the ground truth is established via quantitative physiological measurements (SavO2 from blood draws), there is no need for expert adjudication methods in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

• No. An MRMC comparative effectiveness study was not performed. This device is a diagnostic/monitoring tool that directly measures a physiological parameter, not an AI-assisted diagnostic imaging tool where human reader performance would be a relevant metric for comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes. The performance of the O3 Regional Oximeter System (including the O3 Neonatal Sensor) is evaluated as a standalone device. Its "Trending ARMS" and "Absolute Accuracy" are measured against physiological ground truth (SavO2 from blood). There is no "human-in-the-loop" component in its core functional performance evaluation described here, as it directly outputs rSO2 measurements.

7. The Type of Ground Truth Used:

• Physiological Ground Truth:
  • For Trending ARMS: Blood testing (specifically SavO2, which is defined as "0.3 SaO2 + 0.7 SjvO2"). This is considered the gold standard for blood oxygen saturation. The Neonatal Sensor's performance was also compared relative to the O3 Adult Sensor, which was previously validated against blood testing.
  • For the absolute accuracy convenience sample: Invasive SavO2 blood draws.

8. The Sample Size for the Training Set:

• Not specified. The document describes clinical studies performed for performance validation (test set), but does not provide information about any training sets used for the development or calibration of the device's algorithms. As an oximetry device, its core algorithms are likely based on established biophotonics principles and may not involve a separate "training set" in the same way machine learning algorithms do, but rather extensive calibration and verification data.

9. How the Ground Truth for the Training Set was Established:

• Not specified. Since details about a specific "training set" are not provided, the method for establishing its ground truth is also not mentioned. It is generally understood that the algorithms for such devices are developed and calibrated using a controlled experimental setup with known ground truth parameters for oxygen saturation.

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