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Belun Ring BLR-200 is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for spot-checking and/or continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

Belun Ring BLR-200 consists of two parts: a Ring, and a host program. The Ring, which has smooth and light design and is easy to wear and take off, is intended to be worn on the bottom of index finger providing comfortable and accurate measurements. To make the Optical module appropriately contact with the soft part of the finger, the Ring arm is designed to be changeable for fitting different sizes of fingers. The Ring transfers the collected data to host via Bluetooth low power technology. The host program translates the collected data into text and graph which can be easily interpreted by the user.

The system consists of two main platforms, namely Ring and host. It includes one embedded software and one host program, namely Ring firmware embedded in Ring and Belun Ring Management (BRM) executed in host respectively. The Ring is responsible for signal acquisition, data processing, parameters calculation (SpO2/PR algorithm), sensor interfacing and data storage. The host is for data display, data export and user interface. The system is modularized, and the communication protocol is proprietary. The system is secured with cybersecurity measures.

This document is a 510(k) summary for the Belun Ring BLR-200. It doesn't contain a detailed study report that proves the device meets specific acceptance criteria with reported device performance, sample sizes, expert qualifications, or details about standalone or MRMC studies.

However, based on the provided text, I can infer some information about how the device's accuracy was tested and the general approach to demonstrating substantial equivalence.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document mentions that "The SpO2 and pulse rate accuracy of proposed device have also been tested on healthy subjects and compared with the predicate device in hypoxia tests." However, it does not explicitly state specific acceptance criteria (e.g., A_rms value for SpO2 accuracy) or provide the reported device performance values for these tests. It only states that the device was tested for accuracy.

Therefore, a table cannot be constructed with the detailed information you requested.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document states that accuracy was tested "on healthy subjects" for hypoxia tests. It does not specify the number of subjects used for the test set.
• Data Provenance: Not explicitly stated. The applicant is based in Hong Kong, but the location of the hypoxia tests is not mentioned. It is implied to be prospective since it describes testing performed on "healthy subjects."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. For pulse oximetry accuracy during hypoxia tests, the ground truth is typically established by an arterial blood gas co-oximeter reading, not by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable in the context of pulse oximetry accuracy testing against a reference standard (e.g., arterial blood gas co-oximeter). Adjudication methods are more commonly used when human interpretation of data is being assessed.

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

There is no indication of an MRMC comparative effectiveness study involving human readers or AI assistance in this document. The device is a standalone pulse oximeter.

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

Yes, a standalone performance assessment was done. The document states:

• "The SpO2 and pulse rate accuracy of proposed device under low perfusion and motion conditions have been tested against functional tester."
• "The SpO2 and pulse rate accuracy of proposed device have also been tested on healthy subjects and compared with the predicate device in hypoxia tests."

These describe assessments of the device's (algorithm's) performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the hypoxia tests, the ground truth for SpO2 and pulse rate accuracy is implicitly established by a reference method, typically a co-oximeter measurement from arterial blood samples. This is the standard for pulse oximeter accuracy testing.

8. The sample size for the training set

This information is not provided. The document primarily focuses on demonstrating substantial equivalence through testing of the final device, not on the developmental or training phases of its algorithms.

9. How the ground truth for the training set was established

This information is not provided.

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