(79 days)
The Philips disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Indicated for adult/infant/neonatal (M1133A) and infant (M1132A) 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 nonabsorbed 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 510(k) summary for the Philips Disposable SpO2 Sensors M1132A and M1133A includes information on the general verification and validation testing, but it does not provide specific quantitative acceptance criteria or detailed results of a study that directly proves the device meets those criteria in the format requested.
The document states:
- "Testing involved environmental, safety testing from hazard analysis, interference testing, and clinical evaluations for accuracy. Hardware verification testing was also conducted."
- "Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate device."
- "Test results showed substantial equivalence."
This is a general statement of testing and conclusion of substantial equivalence, but it lacks the specific data points needed to fill out the detailed table and answer all the questions. The most relevant information regarding accuracy is the mention of "controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)" for establishing calibration curves. However, this describes how the calibration curves were derived, not a specific performance evaluation study with acceptance criteria and results for the device itself.
Therefore, many of the requested details cannot be extracted directly from this 510(k) summary.
Information that can be extracted or inferred:
- Type of Ground Truth: The calibration curves are based on "controlled hypoxia studies" with measured arterial oxygen saturation (SaO2), which can be considered a form of clinical reference standard (arterial blood gas analysis).
- Sample Size for Training Set: The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers" were used to establish the calibration curves (which serve as a "validated calibration table"). The specific number of volunteers is not provided.
- How Ground Truth for Training Set was Established: Through "controlled hypoxia studies" where SaO2 (arterial oxygen saturation) was measured directly from the volunteers.
Information NOT available in the provided document:
- A table of specific quantitative acceptance criteria and reported device performance.
- Sample size used for a test set (as distinct from the calibration/training data).
- Data provenance for a test set.
- Number of experts and their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
- Specific quantitative results from a standalone performance study with acceptance criteria.
Summary based on available information:
1. Table of Acceptance Criteria and Reported Device Performance
- Not provided in this document. The document states "Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate device," but does not detail these criteria or specific performance results for the device in a test set context.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document describes "clinical evaluations for accuracy" but does not give a sample size for a separate test set used to validate the device.
- Data Provenance: Not explicitly stated for a test set. The calibration curves were based on studies with "healthy non-smoking adult volunteers," implying prospective data. The country of origin is not specified for these studies, though the submitting company is based in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. The document refers to "controlled hypoxia studies" for calibration curves, which typically involve trained medical staff, but does not specify the number or qualifications of experts for establishing ground truth for a device performance test set.
4. Adjudication method for the test set
- Not provided.
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
- Not applicable/Not provided. This device is a disposable SpO2 sensor, which provides a direct measurement, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself (sensor + algorithm) makes a standalone measurement. The document states "clinical evaluations for accuracy" were done, implying a standalone performance assessment against a clinical reference. However, specific quantitative results from such a study and its acceptance criteria are not detailed.
7. The type of ground truth used
- Clinical Reference Standard (Arterial Oximetry): Calibration curves were derived from "controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)". SaO2 measured directly from arterial blood is the accepted clinical gold standard for oxygen saturation. This is the "ground truth" against which the device's SpO2 measurements are implicitly compared or from which its calibration is derived.
8. The sample size for the training set
- Not provided. The document only states "healthy non-smoking adult volunteers" were used for the controlled hypoxia studies to generate calibration curves. The specific number of volunteers is not mentioned.
9. How the ground truth for the training set was established
- Controlled Hypoxia Studies with SaO2 measurements: The ground truth for the calibration curves was established through "controlled hypoxia studies" where the arterial oxygen saturation (SaO2) was directly measured from the blood of healthy, non-smoking adult volunteers. This typically involves arterial blood gas sampling and analysis.
§ 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).