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The device is a noninvasive bioimpedance meter used to estimate body fat percentage in the home setting. The device is for normal, healthy people only, age range is 10 to 80 years old. The device is to be used in a home environment having normal temperature and humidity conditions.

AQ-830 Slim Body, Body Fat Monitor is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.

The provided document describes a 510(k) premarket notification for the "AQ-830 Slim Body, Body Fat Monitor." The document indicates that a comparative study was conducted to demonstrate the device's performance.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document states "Subjects were grouped as male/female, ages." However, it does not specify the total number of subjects or the breakdown of subjects within those groups.
• Data Provenance: The study involved a "comparison study with device that met absorptiometry (DEXA) technology." The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document explicitly states that the comparison study was performed using "DEXA (Dual Energy X-ray Absorptiometry) technology" as the reference method. DEXA itself is considered a gold standard for body composition measurement, so direct human experts establishing ground truth for individual measurements in the test set are not mentioned as being involved in this capacity. The DEXA measurements served as the ground truth.

4. Adjudication Method for the Test Set

Not applicable. As DEXA technology was used as the ground truth, there's no mention of human expert adjudication for the test set.

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

No. The study described is a comparison of the AQ-830 device's measurements against DEXA, not a comparative effectiveness study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes. The study described focuses on the "repeatability of AQ-830 Slim Body, Body Fat Monitor" against DEXA, indicating a standalone performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used was DEXA (Dual Energy X-ray Absorptiometry) technology, which is a widely accepted and accurate method for measuring body composition and body fat percentage.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description of the study focuses on the comparison study performed to demonstrate performance, implying this data was used for validation rather than training a separate algorithm that needed a training set. This is a medical device that likely relies on established bioimpedance principles and calibration, rather than a deep learning model requiring a large training set in the conventional sense.

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

Not applicable, as a distinct training set for an algorithm is not described. The device's calibration and underlying algorithms would be based on established scientific principles of bioimpedance and potentially data from previous research, but this document doesn't detail a specific training set for the current device's development. The "ground truth" mentioned in the context of the study relates to the reference method (DEXA) for validating the device's performance.

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