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The Masimo SET® Rad-5v Pulse Oximeter is intended for non-continuous noninvasive monitoring of finctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO3 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.

The Rad-5v Handheld Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The Masimo SET® Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo SET® Rad-Sv Handheld Pulse Oxineter is noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-ITIC Mannin SEE - Not of Principely that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Pulse Amplitude Index (PAI) and Signal Quality (SQ).

Here's an analysis of the acceptance criteria and the studies that prove the Masimo SET® Rad-5v Pulse Oximeter meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" presented above are directly derived from the device's stated "Specifications and Operating Ranges" and the accompanying notes, which describe the validation methods and expected accuracy.

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

The document does not explicitly state a numerical "sample size" for the test set in terms of the number of subjects or data points. However, it mentions:

• Human Blood Studies on Healthy Adult Volunteers: Used for no motion and motion accuracy (induced hypoxia).
• Clinical Studies on Neonates: Used for no motion conditions and low perfusion.
• Bench Top Testing: Used for low perfusion accuracy against simulators.

The data provenance is prospective human studies conducted as "clinical studies" and "human blood studies" as well as bench testing. The country of origin is not explicitly stated, but the company address is in Irvine, CA, USA, and the submission is to the US FDA, implying testing was likely conducted in the USA or under US regulations.

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

The document does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore no effect size for human readers with and without AI assistance can be determined. Pulse oximetry is a direct measurement device, not typically requiring human interpretation of complex images or data in an MRMC study context.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done. The entire testing described (bench testing and clinical studies against co-oximeters and ECG) establishes the algorithm's performance without specific human interpretation or intervention in the measurement process, other than device operation. The device continuously displays numeric values, implying an algorithmic output.

7. Type of Ground Truth Used

The ground truth used for the clinical and human blood studies was:

• Arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter: For SpO2 accuracy.
• ECG monitor: For pulse rate accuracy.

For bench testing, the ground truth was provided by:

• Brotek Index 2 simulator and Masimo's simulator: For low perfusion accuracy.

8. Sample Size for the Training Set

The document does not provide a sample size for the training set. It states that the "values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions." This implies that data from human studies was used to develop or calibrate the device's algorithms (the look-up table), but the specifics of that dataset size are not detailed.

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

The ground truth for the look-up table (which serves as the basis for the algorithm's calculation) was established by:

• Human blood studies against a laboratory co-oximeter in induced hypoxia states during motion and non-motion conditions. The document indicates that the device's fundamental conversion algorithm from absorbance signals to SpO2 values is derived from these studies.

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