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The BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.

The proposed Athletic IQ, Inc. (AIQ) BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old. The device determines estimated body fat percentage based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive, whereas fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA permits differentiation of fat vs. lean tissue. When combined with the subject's height and weight parameters, age, and gender, an estimated body fat percentage may be calculated using an experimentally derived algorithm.

The provided text states that "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data." However, it does not provide details on the acceptance criteria, the specific study design, or the results of this clinical testing. Therefore, I cannot construct the requested tables or provide detailed answers to many of your questions based only on the provided text.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not specified in the provided text.
• Reported Device Performance: Not specified in the provided text, beyond the general statement that "Clinical testing was conducted to establish the algorithm."

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (country of origin, retrospective/prospective).

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)

• Not specified.

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

• Not specified.

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

• Not applicable/Not specified. This device is a diagnostic tool, not an AI-assisted interpretation tool for human readers. It directly provides an estimated body fat percentage.

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

• Yes, implicitly. The device "determines estimated body fat percentage based on bioelectrical impedance analysis (BIA)" and calculates it "using an experimentally derived algorithm." This indicates a standalone algorithm performance without human intervention in the result generation. However, the performance metrics for this standalone algorithm are not provided.

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

• Not specified. For body fat analysis, a common ground truth method would be DEXA (Dual-energy X-ray absorptiometry) or hydrostatic weighing, but the text does not mention the method used.

8. The sample size for the training set

• Not specified. The text mentions "an experimentally derived algorithm," implying a training set was used, but no details are given.

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

• Not specified.

Summary of what is known from the provided text:

• Device Name: BC100 Body Composition Analysis System
• Intended Use: Noninvasive bioimpedance analyzer for measurement of actual height, actual weight, and estimated body fat percentage in healthy subjects aged 10-80 years old.
• Technology: Bioelectrical Impedance Analysis (BIA) combined with subject's height, weight, age, and gender, using an experimentally derived algorithm.
• Performance Claim: "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data."
• Regulatory Conclusion: Found "safe and effective for its intended use" based on this clinical testing and comparison to predicate devices.

Missing Information:

Crucially, the provided 510(k) summary and FDA letter do not contain the detailed clinical study results, acceptance criteria, or sample sizes that would allow for a comprehensive answer to your request. These details are typically found in the full 510(k) submission, not necessarily in the summary or clearance letter.

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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, and the applicable age range is 10 to 80 years old.

The device is to be used in a home environment having normal temperature and humidity conditions.

HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.

Here's a breakdown of the acceptance criteria and study information for the HEALTH & LIFE HL 188 & HL 189 BODY FAT METER, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it indicates the device's performance was validated through a comparison study and conformity to standards.

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

• Sample Size: The text states, "Subjects were grouped as male/female, ages." It does not provide a specific number for the sample size.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be clinical. It does not specify if it was retrospective or prospective, but clinical comparison studies are generally prospective.

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

This information is not provided in the text. The ground truth was established by comparing to DEXA technology, but details on human experts involved are absent.

4. Adjudication Method for the Test Set

This information is not provided in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The study described is a comparison with DEXA technology to validate the device's performance, not a human reader study with or without AI assistance.
• Effect Size: Not applicable, as an MRMC study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the described "comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology" is essentially a standalone performance evaluation of the HL 188 & HL 189 Body Fat Meter against a reference standard. The text focuses on the device's direct measurement capabilities.

7. The Type of Ground Truth Used

The ground truth was established using DEXA (Dual energy X-ray absorptiometry) technology. DEXA is considered a highly accurate and reliable method for body composition analysis, often used as a reference standard.

8. The Sample Size for the Training Set

This information is not provided in the text. The device is a "Body Fat Meter" which implies it's a measuring device rather than an AI/ML algorithm that requires a separate training set. The comparison study described is for validation.

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

Not applicable, as a separate training set for an AI/ML algorithm is not described for this type of device. The device directly measures bioimpedance to estimate body fat percentage. The validation study used DEXA as the ground truth for performance comparison.

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