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DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.

DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis).

Given the provided document, the acceptance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed in the format requested. The document is a 510(k) clearance letter from the FDA, which confirms substantial equivalence to a predicate device, but does not typically include the full details of performance studies or acceptance criteria.

However, based on the information that can be extracted, here's what can be inferred and directly stated:

Device Name: DUTECK (MicHealth) Body Composition Analyzer, Model BSA Series (BSA-1505, -1506, -1508, -1605, -1606, -1608, -1705, -1706, -1708)
Regulation Name: Impedance plethysmograph
Product Code: MNW
Indications for Use: DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzers. They measure body weight and impedance and estimate body composition (body fat, body water, and skeletal muscle mass) by using the BIA method (bioelectrical impedance analysis). They are intended for use by healthy people aged 10 to 80, for effective lifestyle body composition assessment in the home environment.

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

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

The document does not explicitly state acceptance criteria or provide a table of performance data.
The FDA letter indicates that the device has been found "substantially equivalent" to legally marketed predicate devices. This means that the device's performance, as demonstrated in the 510(k) submission, was deemed comparable to that of a previously cleared device. However, the specific metrics and thresholds for that equivalence are not provided in this letter.

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

This information is not available in the provided 510(k) clearance letter. Market clearance via a 510(k) relies on demonstrating substantial equivalence to a predicate device, which typically involves comparing device specifications and potentially limited performance data, but the detailed study protocols (sample size, data provenance) are not usually included in the public-facing clearance letter.

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 available in the provided document. The 510(k) letter does not detail the specifics of ground truth establishment for any performance studies.

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

This information is not available in the provided document. Adjudication methods are typically part of detailed clinical study protocols, which are not included in this clearance letter.

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 type of study is not applicable to this device. The DUTECK Body Composition Analyzer is a measurement device that estimates body composition using BIA, not an AI-assisted diagnostic tool that requires human readers for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

Given the nature of the device as a "stand-on, non-invasive, reusable analyzer" that "estimates body composition... by using BIA method," it operates as a standalone algorithm/device without human-in-the-loop performance for its core function of estimation. The user interacts with the device by standing on it, and the device then provides the estimations. The FDA letter confirms the device's ability to perform these estimations for "body fat, body water and skeletal muscle mass."

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

The document does not specify the type of ground truth used for any performance studies. For body composition analyzers, common ground truth methods in scientific studies include DEXA (Dual-energy X-ray absorptiometry), hydrostatic weighing, or direct chemical analysis (though the latter is usually for cadaver studies). The 510(k) letter does not reveal which, if any, of these methods were used for comparison.

8. The sample size for the training set

This information is not available in the provided document. Details about training sets are typically part of a detailed technical submission, not the public clearance letter.

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

This information is not available in the provided document. Similar to the test set, the methods for establishing ground truth for any potential training set are not disclosed in this letter.

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