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The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 20 to 80 years old.

The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.

AVITA BF1(Vitalio) Body Fat Analyzer is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.

This 510(k) summary describes the AVITA BF1 (Vitalio) Body Fat Analyzer, which is a hand-held, non-sterile, reusable device intended for estimating body fat percentage in the home.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria (e.g., a specific percentage of agreement, a required correlation coefficient, or a defined accuracy margin). Instead, it states the overall conclusion of the study's performance.

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

The document does not specify the sample size for the comparison study.
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. It merely mentions "A comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology was performed".

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

The document does not mention using experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method.

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:

This is not applicable to this device. The AVITA BF1 (Vitalio) Body Fat Analyzer is a standalone device for estimating body fat percentage, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, a standalone performance assessment was conducted. The "comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology" directly evaluates the performance of the AVITA BF1 device (algorithm only, as there's no human interpretation component) against a reference standard.

7. The Type of Ground Truth Used:

The ground truth used for the test set was obtained from a DEXA (Dual energy X-ray absorptiometry) device. DEXA is considered a highly accurate method for measuring body composition, including body fat percentage, and is often used as a reference standard in such studies.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. This suggests the device might be based on established bioimpedance principles and a pre-existing algorithm, rather than being a newly developed AI model requiring a separate training phase described in this submission.

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

As no training set is mentioned, information on how its ground truth was established is not provided.

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