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The Pulse Oximeter is intended for spot-checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child users in hospitals, hospital facilities and home healthcare environments.

The Pulse Oximeter model BM20, can display the SpO2 and PR, plethysmogram wave and other indication parameters, such as pulse battery power status and the PI. The model BM20 Pulse Oximeter include the mainboard, display and lithium battery. It has small size, light weight, easy to carry. It adopts low power consumption design, and has the function of battery capacity display.

The pulse oximeter, model BM20, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults, pediatric and adolescent patients in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios. This medical device can be reused. Not for continuously monitoring.

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The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) 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, BM1000C. The two proposed devices all are fingertip device; they are share the following same features:

• Spot check and display SpO2 and PR value;
• Low battery capacity indicator;
• Finger off indicator;
• wireless connection function
  Beside the features above, the BM1000 can display Plethysmogram wave, but the BM1000C deoesn't have this function.
  The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of thefunctional oxygen saturation of arterial hemoglobin (SpO2) 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 a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states for SpO2 accuracy that while the predicate had a $\pm 2%$ criterion, the proposed device's Arms of $1.50%$ meets the requirements of ISO 80601-2-61, which FDA recognizes, and therefore this difference is considered acceptable. Similarly, for PR measurement range, despite a slight difference, it's considered to cover general pulse rates and is clearly labeled.

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

• Sample Size: 12 healthy adult volunteer subjects.
• Data Provenance: Prospective, conducted in a laboratory setting (invasive laboratory testing on healthy volunteers). The location of the study is not explicitly stated beyond "healthy adult volunteer subjects," but the company is based in China.

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

• The ground truth was established by CO-Oximetry on arterial blood samples. This is a direct, reference standard measurement and does not involve human experts for interpretation in the same way an imaging study would.
• The document does not detail individual "experts" or their qualifications for establishing this ground truth, as it's a technical measurement rather than expert consensus on a subjective interpretation.

4. Adjudication Method for the Test Set:

• Not applicable in the traditional sense for medical diagnostic imaging adjudication. The ground truth (SaO2) was determined directly from arterial blood CO-Oximetry measurements. Simultaneous data collection from test devices and the immediate analysis of blood samples on reference CO-Oximetry implies a direct comparison, rather than an adjudication process of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone accuracy of the device against a physiological ground truth, not on human reader performance with or without AI assistance.

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

• Yes, a standalone performance study was done. The clinical trial directly evaluated the "SpO2 accuracy performance of the BM1000C Fingertip Pulse Oximeter" against arterial blood CO-Oximetry. This tests the device's accuracy as a standalone measurement tool.

7. The Type of Ground Truth Used:

• Physiological Measurement (Reference Standard): The ground truth for SpO2 accuracy was established through arterial blood CO-Oximetry, providing functional SaO2. This is considered a highly accurate and direct measure of blood oxygen saturation.

8. The Sample Size for the Training Set:

• The document does not explicitly state a sample size for a "training set." This type of device (pulse oximeter) typically does not involve machine learning models that require distinct training sets in the same way an AI diagnostic device would. Its core principle relies on physiological properties of light absorption by oxygenated and deoxygenated hemoglobin. The study described focuses on clinical validation of the final device's accuracy.

9. How the Ground Truth for the Training Set was Established:

• As a training set is not explicitly mentioned or implied for this type of device based on the provided text, the method for establishing its ground truth is not applicable/provided.

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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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