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The Tanita Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body and segmental fat percent and weight, total body water percent and weight, intracellular and extracellular water weight, total body and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), and fat free mass (FFM), using BIA (Bioelectrical Impedance Analysis).

The device is indicated for use for healthy children 5–17 years old and healthy adults with active, moderately active, to inactive lifestyles.

For subjects 17 years old and younger, only fat % is displayed.

The Tanita Model MC-180MA Multi-frequency Body Composition Analyzer is a computer-operated body composition analyzer that utilizes bioelectrical impedance analysis (BIA) to estimate body composition of fat, muscle and bone, water compartments, and basal metabolic rate (BMR).

Actual measurements made by the MC-180MA include body weight and bioelectrical impedance. BIA is used to make estimates based upon these measured values.

Here's an analysis of the provided text regarding the Tanita MC-180MA Multi-frequency Body Composition Analyzer and the requested information.

It's important to note that the provided text is a 510(k) summary for a premarket notification to the FDA. These documents primarily focus on demonstrating "substantial equivalence" to existing predicate devices, rather than detailed performance studies with acceptance criteria in the way a clinical trial for a novel drug or a high-risk medical device might. Therefore, some of the requested information (like specific acceptance criteria thresholds, detailed study outlines with sample sizes for test sets, expert qualifications, and multi-reader multi-case studies) is generally not present in this type of FDA submission. The focus here is on technological characteristics comparison rather than rigorous clinical validation against an established gold standard for accuracy metrics.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K100183 510(k) summary, specific numerical acceptance criteria (e.g., "accuracy must be within X% of the gold standard") are not explicitly stated or detailed. The document focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because its underlying technology and intended use are similar to already cleared devices.

The document states:

• "Multiple-frequency measurement of bioelectrical impedance values used in estimation of percent fat, fat-free mass, total body water and extracellular water was verified in clinical testing." This indicates some form of testing was done, but details are not provided.
• "Comparison of these intended-use and technological characteristics demonstrate that the Model MC-180MA is substantially equivalent to predicate devices." This is the core "performance" claim in the context of a 510(k).

Therefore, a table of explicit acceptance criteria and corresponding performance cannot be constructed from the provided text. The "acceptance criterion" is effectively: "demonstrate substantial equivalence to predicate devices." The "reported device performance" is the assertion that this substantial equivalence has been met through comparison of technological characteristics and clinical verification.

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

The document mentions "verified in clinical testing," but does not specify the sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the "clinical testing").

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

This information is not provided in the 510(k) summary. For Bioelectrical Impedance Analysis (BIA) devices, "ground truth" would typically involve comparison to a more established body composition measurement method (e.g., DEXA, hydrostatic weighing), rather than expert consensus on images.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of BIA devices, clinical adjudication by human experts in the way it's done for image analysis or diagnostic tools is generally not applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this device type (body composition analyzer using BIA) and is not mentioned in the document. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the study assesses the impact of AI assistance on their performance. This device is a standalone measurement tool.

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

Yes, implicitly. The device itself, the Tanita MC-180MA, is a standalone algorithm (BIA) that measures impedance and then applies algorithms to estimate body composition. The "clinical testing" mentioned would have been to verify the accuracy of these algorithms in producing the stated outputs. The device operates independently of human interpretation in its core function.

7. The Type of Ground Truth Used

The document implicitly refers to "clinical testing" where "multiple-frequency measurement of bioelectrical impedance values... was verified." For BIA devices, the "ground truth" for verification typically involves comparison with established, more accurate body composition assessment methods such as:

• Dual-energy X-ray absorptiometry (DEXA)
• Hydrostatic weighing (underwater weighing)
• Isotope dilution
• Magnetic Resonance Imaging (MRI)
• Computed Tomography (CT)

However, the specific "type of ground truth" method used in their verification is not explicitly stated in the provided text.

8. The Sample Size for the Training Set

The document does not specify the sample size for any training set. It refers to "multiple-regression algorithms to predict body composition," implying that these algorithms were trained or developed using some dataset, but the size is not disclosed.

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

The document does not specify how the ground truth for any training set was established. Similar to point 7, it would likely involve comparisons to other body composition assessment methods, but details are not provided.

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