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The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and < 40 kg in healthcare environments.

The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.

The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn is connected to the 03 Module. Up to two 03 Sensors can be connected to each 03 Module and both sensors can be connected to a patient.

The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root in turn is powered by either AC power or internal rechargeable batteries.

The O3 System 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 user-defined rSO2 low alarm limit (LAL)
• Delta SpO2 (ΔSpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

The provided document describes the Masimo O3 Regional Oximeter System, specifically focusing on the O3 Pediatric Sensor, and its equivalence to predicate devices (K160526 and K082327). The document outlines non-clinical and clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for accuracy are presented as ARMS (Accuracy Root Mean Square) values.

(Emphasis added to highlight the performance of the device under review, the O3 Pediatric Sensor)

2. Sample size used for the test set and the data provenance

• Sample Size for Absolute ARMS (Pediatric): 33 male and female pediatric patients.
• Sample Size for Trending ARMS (Pediatric): Not explicitly stated as a distinct number of patients. The trending study used the O3 Large Sensor as a reference and collected rSO2 data from both the O3 Large Sensor and O3 Pediatric Sensor. It's implied this was performed on a subset or all of the 33 pediatric patients, but the exact number for the trending analysis isn't isolated.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study involved "pediatric patients," suggesting human clinical data. It is a prospective study, as blood draws were taken "before and after his/her medical procedure" for the absolute ARMS, and trending data was collected.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for the rSO2 measurements was established by "blood draws (arterial and jugular blood)" which were then analyzed to determine blood oxygen saturation. This is a direct physiological measurement, considered objective, and does not involve human expert interpretation in the same way imaging studies might. Therefore, the concept of "number of experts" with specific qualifications for ground truth establishment (like radiologists) is not applicable here. The accuracy is against a direct physiological laboratory standard, not an expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Since the ground truth for both absolute and trending accuracy was based on direct blood measurements (physiological reference), there was no adjudication method involving human experts for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is an oximeter, which provides a direct measurement (rSO2) rather than an interpretation that would be assisted by AI. The document describes a comparison of the device (O3 Pediatric Sensor) against a physiological reference and against another sensor (O3 Large Sensor for trending), not human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the primary performance evaluation for accuracy (Absolute ARMS and Trending ARMS) is a standalone (algorithm only) performance evaluation. The device provides the rSO2 measurements directly, based on its NIRS technology and signal processing. The accuracy is reported for the device's measurements compared to a reference standard (blood draws or another sensor). While a human user reads the display, the accuracy itself is of the device's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was physiological measurements (blood draws) for absolute accuracy. Specifically, "Blood draws (arterial and jugular blood) were taken for each subject." For trending accuracy, the O3 Large Sensor's measurements (which were previously established via blood reference) served as the comparative ground truth.

8. The sample size for the training set

The document does not specify a separate training set sample size. This is typical for a device submission that primarily focuses on hardware and embedded algorithms, where the "training" (calibration and algorithm development) often occurs internally during the device development phase, and the submission focuses on the validation or test data. The "Clinical Testing" section describes the validation study for the new O3 Pediatric Sensor.

9. How the ground truth for the training set was established
As the document does not explicitly mention a separate "training set," it does not describe how ground truth for such a set was established. It describes the ground truth for the clinical validation (test) set, which was established through blood draws (arterial and jugular blood), considered the reference standard for blood oxygen saturation. It's reasonable to infer that the underlying scientific principles and initial calibrations would have relied on similar, well-established physiological measurement techniques.

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The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (tSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg in healthcare environments.

The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.

The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn connected to the 03 Module. Up to two 03 Sensors can be connected to each O3 Module and both sensors can be connected to a patient.

The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root). Root in turn is powered by either AC power or internal rechargeable batteries.

The O3 System provides the following key measurements:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep o tissue local to the sensor site, including cerebral tissue
• o 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 user-defined rSO2 low alarm limit (LAL)
• o Delta SpO2 (dSpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

Here's a summary of the acceptance criteria and study information for the Masimo O3 Regional Oximeter System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "SavO2": The document mentions "SavO2" in the context of the clinical study, stating accuracy against "30% arterial and 70% jugular venous blood oxygen saturations". This implies that SavO2 is a composite measure or target for regional oxygen saturation, often calculated based on arterial and venous contributions. The acceptance criteria for rSO2 accuracy are directly related to this measured range.

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

• Sample Size: "healthy adult male and female subjects with light to dark skin pigmentation." The specific number of subjects is not provided in the document.
• Data Provenance: The study was a prospective clinical study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be from a region where clinical trials meet FDA standards, likely the USA.

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

• Number of Experts: This information is not applicable as the ground truth was established by direct physiological measurements, not expert review of images or data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by direct physiological measurements using a laboratory CO-Oximeter.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a measurement device, not an imaging interpretation aid for human readers.

6. Standalone Performance Study

• Standalone Performance: Yes, the clinical study explicitly evaluates the device's accuracy ("trending and absolute rSO2 accuracies were determined") against a laboratory standard, indicating a standalone performance study without human intervention in the primary measurement.

7. Type of Ground Truth Used

• Ground Truth Type: Physiological measurements: "30% arterial and 70% jugular venous blood oxygen saturations, measured by a laboratory CO-Oximeter." This is a direct, objective physiological measurement.

8. Sample Size for the Training Set

• Sample Size: The document does not specify a separate training set or its sample size. For simple measurement devices like an oximeter, "training" often refers to the device's inherent calibration and algorithm development, which might not involve a distinct, large-scale "training set" in the same way machine learning models for image analysis do. The clinical study described appears to be the primary validation set.

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

• Ground Truth for Training: As no distinct training set is described, this information is not provided in the document. It's likely that the device's algorithms were developed and refined through engineering and calibration processes against established physiological principles and potentially internal studies, rather than a publicly reported "training set" with ground truth established through a formal process analogous to a clinical trial.

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