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The Philips Reusable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation.

M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.

The Philips SpO2 devices measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.

The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called Ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].

SpO2 = [HbO2]/([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 100%-70%), the Ratio can be related to a SpO2 value.

The devices contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.

The provided text describes a 510(k) submission for Philips Reusable SpO2 Sensors. Here's a breakdown of the requested information:

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

The document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates that "clinical evaluations for accuracy" were conducted and "Test results showed substantial equivalence." The basis for calibrating the saturation values is described: "Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%), the Ratio can be related to a SpO2 value."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers."

• Sample Size: Not explicitly stated, but implies a cohort of "healthy non-smoking adult volunteers."
• Data Provenance: The study involved human volunteers, making it a prospective clinical study. The location of the study is not specified, but the applicant (Philips Medizin Systeme Boeblingen GmbH) is based in Germany, and typically such studies would be conducted in the country of origin or a relevant regulatory jurisdiction.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The establishment of ground truth ("calibration curves") for SpO2 measurements in hypoxia studies typically involves:

• Ground Truth Method: Direct arterial blood gas analysis, which is considered the gold standard for arterial oxygen saturation (SaO2).
• Number of Experts/Qualifications: The document does not specify the number or qualifications of medical professionals (e.g., intensivists, pulmonologists, clinical researchers) involved in conducting the hypoxia studies or performing arterial blood gas measurements. However, such studies are inherently under the supervision of qualified medical personnel.

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

The document does not describe an adjudication method as it pertains to expert consensus on interpretation. For SpO2 measurement, the ground truth (direct SaO2 from blood gas) is a quantitative measurement, not subject to subjective adjudication by multiple readers in the same way an image interpretation might be.

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 study was done. This device is a sensor (hardware) that provides a direct physiological measurement (SpO2), not an AI-driven interpretation system that assists human readers.

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

• Yes, a form of standalone performance was assessed. The device itself, as an oximeter sensor and an internal algorithm, calculates the SpO2 value. The "clinical evaluations for accuracy" and "calibration curves" against directly measured SaO2 from blood gases represent a standalone performance assessment of the device's ability to accurately measure SpO2. This is the device operating without human judgment to interpret the output.

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

The ground truth used for establishing the calibration curves was physiologically derived actual arterial oxygen saturation (SaO2), typically measured via co-oximetry from arterial blood samples. This is obtained during "controlled hypoxia studies."

8. The sample size for the training set

The document refers to "controlled hypoxia studies with healthy non-smoking adult volunteers" for establishing calibration curves. The sample size for these calibration studies is not explicitly stated.

9. How the ground truth for the training set was established

The ground truth for the calibration curves (which serve as the basis for the device's "training" or fundamental operational logic) was established through controlled hypoxia studies. In these studies, healthy volunteers' arterial oxygen saturation (SaO2) was varied and simultaneously measured using a gold standard method (e.g., co-oximetry via arterial blood gas analysis) while the device's raw signal ratio was recorded. This allowed for the correlation of the device's internal ratio to a true SaO2 value, creating the "validated calibration table."

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