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The Healthometer Professional Body Fat Monitor and Scale is indicated to measure body weight and impedance and estimate body fat percent.

The Bonso BFM is a portable device for measuring the percentage of body fat in human subjects. The device includes a platform-type weighing scale that utilizes internal strain gauges to electronically measure the weight of a subject standing on the scale platform.

The Bonso Electronics International Inc. Healthometer Professional Body Fat Monitor and Scale (Models BFM940, BFM945, and BFM960) measures body weight and impedance, and estimates body fat percentage. The device's substantial equivalence was established by comparing it to the Tanita BF-625/BF-626.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than defining specific performance acceptance criteria for the new device and then demonstrating performance against those. The basis for substantial equivalence is that the Bonso device "performs as labeled" and that testing directly comparing the Bonso and the predicate device showed substantial equivalence.

Acceptance Criteria (Implicit from Substantial Equivalence):

• Performance as Labeled: The device must accurately perform its stated functions: measure body weight, impedance, and estimate body fat percent.
• Comparable to Predicate Device: The device's measurements and estimations of body weight, impedance, and body fat percent should be substantially similar to those obtained from the Tanita BF-625/BF-626.

Reported Device Performance:

• "The 510(k) contains extensive bench data demonstrating that the Bonso device performs as labeled."
• "Additionally, testing directly comparing the Bonso and the predicate device was provided. This testing showed that the Healthometer Professional Body Fat Monitor and Scale is substantially equivalent to the Tanita BF-625/BF-626 that is also indicated for use to measure body weight and impedance and estimate body fat percent using the BIA method."

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the sample size used for the comparative testing between the Bonso device and the Tanita predicate device. It only mentions "testing directly comparing the Bonso and the predicate device."
• Data Provenance: The data provenance is not specified. It is likely prospective as it involves "testing directly comparing" the devices, implying a new study was conducted. There is no information regarding the country of origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. The assessment relies on the comparative performance against a predicate device, which itself is an established medical device. There's no indication that an independent panel of experts was used to establish ground truth for the test set.

4. Adjudication method for the test set:

• An adjudication method is not specified. Given that the study involves direct comparison of device measurements, it's unlikely a human-based adjudication method (like 2+1, 3+1) would be primarily used. The comparison would likely be statistical or direct measurement comparison.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases with and without AI assistance. The Healthometer device is a direct measurement device (body fat monitor and scale), not an AI-assisted diagnostic imaging or interpretation system.

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

• Yes, a standalone performance assessment was conducted (implicitly). The "extensive bench data demonstrating that the Bonso device performs as labeled" implies testing of the device's inherent measurement capabilities. The comparison to the predicate device also establishes its standalone performance relative to an existing device. The device itself (a body fat monitor and scale) operates in a standalone manner to provide measurements.

7. The type of ground truth used:

• The ground truth for the performance assessment is the measurements obtained from the predicate device, Tanita BF-625/BF-626, which is "also indicated for use to measure body weight and impedance and estimate body fat percent." It also implicitly relies on the device accurately performing its labeled functions, which assumes the internal strain gauges and BIA methods used are calibrated and accurate. In essence, the "ground truth" for the new device's performance is the performance of the legally marketed predicate device.

8. The sample size for the training set:

• This information is not applicable/not provided. The Healthometer Professional Body Fat Monitor and Scale is a measurement device that uses bioelectrical impedance analysis (BIA) and strain gauges. It is not an AI-driven image analysis or diagnostic system that requires a "training set" in the conventional machine learning sense. Its internal algorithms for converting impedance/weight to body fat percentage would have been developed and validated, but the term "training set" is not relevant here in the context of typical AI/ML studies.

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

• This information is not applicable/not provided for the reasons stated in point 8.

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