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Non-invasive measurement of arterial oxygen saturation and pulse rate in hospitals, physician's office, emergency medical facilities, or at home. The model 34 can store data in memory for later review and documentation and also features a sleep mode for basic patient sleep screening.

The Mediaid Pulse Oximeter Model 34 is designed to measure the percentage of functional oxygenated hemoglobin to total hemoglobin. Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation.

The provided text describes a 510(k) summary for the Mediaid Pulse Oximeter Models M30 and M34. However, it does not contain specific acceptance criteria or detailed results of a study that directly compare the device's performance against predefined criteria in a quantifiable table format.

The document generally states that "Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid Pulse Oximeter Model 34 were compared to arterial blood samples analyzed on a laboratory cooximeter and found to be equivalent to predicate device accuracy claims." It also notes "Bench testing was performed to verify pulse rate accuracy."

Given the limitations of the provided text, I will construct a response based on the information available and indicate where specific details are missing.

Acceptance Criteria and Device Performance for Mediaid Pulse Oximeter Models M30 and M34

The provided 510(k) summary indicates that the Mediaid Pulse Oximeter Models M30 and M34 underwent performance testing to establish substantial equivalence to predicate devices. While specific numerical acceptance criteria and a detailed table of results are not included in the provided text, the summary states that the device was found to be "equivalent to predicate device accuracy claims" based on clinical hypoxia studies and bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not explicitly state the numerical acceptance criteria for SpO2 accuracy (e.g., RMS difference within a certain percentage) or pulse rate accuracy. It relies on the assertion of equivalence to predicate device claims.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated for either the clinical hypoxia study or the bench testing. The document refers to "clinical hypoxia studies" without specifying the number of subjects or data points.
• Data Provenance:
  • Clinical Hypoxia Studies: Conducted in an "independent research lab." The country of origin of the data is not specified.
  • Study Type: These appear to be prospective studies, as they involved testing the device against arterial blood samples.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. For the SpO2 accuracy, the ground truth was established by "arterial blood samples analyzed on a laboratory cooximeter." While the cooximeter itself is an objective measurement tool, the expertise of the individuals operating and interpreting the cooximeter data is not mentioned.

4. Adjudication Method

This information is not applicable/not provided for the types of tests described. The primary ground truth for SpO2 was objective (laboratory cooximeter readings from arterial blood samples).

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

• No, an MRMC comparative effectiveness study was not done according to this document. The testing focused on the standalone performance and accuracy of the device against objective measurements, rather than evaluating the improvement of human readers with AI assistance. Pulse oximeters typically provide direct measurements and are not systems designed for human interpretation of complex images or signals requiring subjective reader analysis and subsequent adjudication.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was done. The clinical hypoxia studies and bench testing directly assessed the performance of the Mediaid Pulse Oximeter Model 34 itself, independent of human interpretation or intervention beyond standard device operation. The device's SpO2 readings were compared to the "ground truth" established by the laboratory cooximeter, representing its standalone accuracy.

7. Type of Ground Truth Used

• For SpO2 Accuracy: The ground truth used was objective laboratory measurements from arterial blood samples analyzed on a laboratory cooximeter (gold standard for arterial oxygen saturation measurement).
• For Pulse Rate Accuracy: The ground truth method is not explicitly detailed beyond "bench testing," but it would typically involve comparison to a known, accurately generated pulse signal.

8. Sample Size for the Training Set

• This information is not applicable and not provided for this device. Pulse oximeters are typically developed using established physiological principles and calibration, not through machine learning models that require training sets with ground truth labels.

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

• This information is not applicable and not provided for this device, as it does not rely on a training set in the context of machine learning.

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