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Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals.

X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.

The SpO2 measurement is based on the absorption of light, which is emitted through human tissue (i.e. index finger). Two light sources transmit red and infrared light through the human tissue. The ratio of the different absorption of the red and infrared light is calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO₂] to the total amount of hemoglobin [Hb] (SpO2 = [HbOz]/({Hb]+[HbO2]). Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value. The measurement accuracy of SpO2 in the range of 70% to 100% is between 2% and 4% RMS dependent on the Philips sensor type. The measurement accuracy of pulse rate in the range of 30 bpm to 300 bpm is 2% or 1 bpm (whichever is greater).

The modification is a hardware and firmware improvement and reduces the manufacturing costs.

Here's an analysis of the acceptance criteria and study details for the picoSAT IIP408 SpO2 pulse oximetry module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 10 volunteers
• Data Provenance: Controlled hypoxia studies with healthy non-smoking adult volunteers. Since the submitter is Philips Medizin Systeme Böblingen GmbH (Germany), it's highly likely the study was conducted in Germany or a similar Western country, but the specific country of origin is not explicitly stated. The study was prospective in nature due to it being a "controlled desaturation study."

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

• Number of Experts: Not applicable in this context.
• Qualifications of Experts: The ground truth was established by a CO-Oximeter as a reference, not human experts. CO-Oximeters are laboratory-grade instruments used for highly accurate blood gas analysis, including oxygen saturation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by instrumental reference (CO-Oximeter) rather than human expert interpretation requiring adjudication.

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

• MRMC Study Done: No. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

• Standalone Study Done: Yes, essentially. The accuracy of the SpO2 measurement is a direct output of the device's hardware and firmware, compared against a reference standard. There is no human "in-the-loop" for the direct SpO2 measurement process itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Instrumental reference – a CO-Oximeter was used to provide SaO2 (arterial oxygen saturation) reference values.

8. The Sample Size for the Training Set

• Sample Size: Not explicitly stated as a distinct "training set" in the context of machine learning model development. For traditional medical device calibration (as described here), "calibration curves" are developed. While the text mentions "Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value," it does not specify a separate sample size for developing these curves, implying some overlap or that the 10 volunteers may have contributed to this process. It explicitly states "at least 20 data samples per volunteer" for the validation study.

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

• Ground Truth Establishment: The "calibration curves" (analogous to a training process for establishing the device's core functionality) were "based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%)." This implies that during these hypoxia studies, a reference method (likely a CO-Oximeter, similar to the validation) was used to establish the true SaO2 values against which the device's internal light absorption ratios were mapped to create the SpO2 output.

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