(72 days)
Philips reusable SpO2 sensors are for multi-patient use, when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required.
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 the Philips Reusable SpO2 Sensor, Models M1191B, M1191BL, and M1191BNL. The document focuses on the substantial equivalence to a predicate device and mentions testing for performance and reliability characteristics. However, it does not provide specific acceptance criteria or the detailed study results that prove the device meets those criteria in the format requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The text states: "Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device." and "Design verification and validation test results confirmed that the device is substantially equivalent with the identified predicate devices." However, it does not specify what those performance characteristics or acceptance criteria were, nor does it present the numerical results from such tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that calibration curves are "based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)." It does not specify the exact number of volunteers/patients or data points used in these studies.
- Data Provenance: The data is prospective, derived from "controlled hypoxia studies with healthy non-smoking adult volunteers." The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The ground truth for SpO2 devices is typically established through arterial blood gas (SaO2) measurements in controlled hypoxia studies. The document mentions "controlled hypoxia studies" but does not detail the methodology for establishing the ground truth or the involvement of experts in that process.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of SpO2 measurements with arterial blood gas as ground truth, a traditional adjudication method (like 2+1, 3+1 for image interpretation) is not typically applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. An MRMC study is generally relevant for AI systems involving human interpretation of medical images. For a device like an SpO2 sensor, such a study is not applicable as it does not involve human readers interpreting output from an AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, implicit in the description. The device itself (the sensor and its associated algorithm) directly measures SpO2. The device description mentions "an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value." The "controlled hypoxia studies" would be a standalone performance evaluation of the device against a physiological ground truth (arterial blood gas saturation).
7. Type of Ground Truth Used
The ground truth used is physiological measurement: arterial oxygen saturation (SaO2) obtained through "controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)."
8. Sample Size for the Training Set
The document mentions "calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers." This implies that data from these studies was used to develop or train the calibration table/algorithm. However, the exact sample size for this (what you're calling the "training set") is not specified.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the "training set" (data used for calibration curves) was established through controlled hypoxia studies where volunteers' actual arterial oxygen saturation (SaO2) was likely measured through arterial blood gas analysis while their oxygen levels were varied. The document states: "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."
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).