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The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

The proposed device, pulse oximeter, includes two models in this application, BM1000A and BM2000A. The two proposed devices all are handheld device with detachable SpO2 sensor, the BM1000A work with the SpO2 sensor BSA09001P and the BM2000A work with the SpO2 sensor BST09001S; they share the following same features:
★ Spot check and display SpO2 and PR value;
★ Low battery capacity indicator;
★ Finger off indicator;
The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
The proposed device is not provided sterile and is not a reprocessed single-use device.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that "A total of 24 samples were obtained per subject." However, it does not explicitly state the number of subjects (healthy volunteers) involved in the clinical trial. Therefore, the exact total sample size for the test set is not provided.
• Data Provenance: The data was generated prospectively during a clinical trial where "Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide." The data was "recorded by Bickler-Ye lab and provided for analysis." The country of origin is not explicitly stated, but the mention of a "Bickler-Ye lab" suggests a research institution. Given the regulatory submission to the FDA (USA), it is plausible that the study was conducted within the US or under internationally recognized standards.

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

• The document describes the ground truth for SpO2 as being determined by "blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen)." This indicates that the ground truth was established by an instrument, not by human experts interpreting data. Therefore, the concept of "number of experts" or their "qualifications" for establishing ground truth for the test set does not directly apply in this context.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned. The ground truth was established by an objective instrument (OSM-3 Hemoximeter).

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

• No MRMC comparative effectiveness study was done. This study focuses on the standalone performance of the device against an established reference method (hemoximetry), not on human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone study was performed. The clinical trial directly compares the device's SpO2 and PR readings against a reference standard (arterial blood gas analysis via hemoximeter) without human intervention in the device's measurement process. The device's "Accuracy Arms" (likely referring to Accuracy Root Mean Square) was found to be "smaller than 3%."

7. Type of Ground Truth Used

• The type of ground truth used was objective instrument data (arterial blood gas analysis to determine oxyhemoglobin saturation using an OSM-3® multi-wavelength oximeter).

8. Sample Size for the Training Set

• The document does not provide information about a separate "training set" for an algorithm. This device is a pulse oximeter, and its accuracy is typically established through direct clinical measurement trials against a recognized standard (like arterial blood gas), rather than through a machine learning model that requires explicit training data. The study described is a validation study.

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

• As no separate training set is mentioned or implied for an algorithm in the context of this device, this question is not applicable. The device's underlying principles are based on known physiological light absorption properties of oxygenated and deoxygenated hemoglobin, and its calibration and validation are performance-based.

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