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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 fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, 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.

The TANITA Body Composition Analyzer SC-331 is a composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body mass index (BMI), total body fat percent, total body water percent and weight, muscle (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.

This document focuses on the Tanita Body Composition Analyzer Model SC-331, a device that uses Bioelectrical Impedance Analysis (BIA) to measure and estimate various body composition parameters. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

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

The acceptance criteria for the Tanita Body Composition Analyzer SC-331 are implicitly established by demonstrating substantial equivalence to its predicate devices (TANTA Body Fat Analyzer Professional and Consumer Models K014009 and K040778, and the TANITA Body Composition Analyzer: Model BC-53X).

The table directly from the 510(k) summary compares the specifications and indicated outputs of the SC-331 with its predicate devices. The "reported device performance" is the statement that the SC-331 "performs equivalently" to these predicate devices based on "the results of [its] whole body BIA."

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

The provided text does not explicitly state the sample size used for the test set. It mentions "the results of [TANITA's] whole body BIA" as the basis for performance claims.
The data provenance is not specified. It does not mention the country of origin of the data, nor whether it was retrospective or prospective. The term "in house BIA and DEXA reference" suggests internal validation data.

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 document. The statement "in house BIA and DEXA reference" for analytical method/measurement implies that DEXA (Dual-energy X-ray absorptiometry) was used as a reference standard, which is considered a gold standard for body composition. However, it does not specify how many experts, if any, were involved in generating or interpreting this ground truth data, nor their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done nor is it applicable to this device. This is a body composition analyzer, not an imaging analysis AI intended to assist human readers. The assessment is purely on the device's accuracy in measuring body composition parameters.

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

Yes, a standalone performance assessment was implicitly performed. The device itself, the TANITA Body Composition Analyzer SC-331, is an algorithm-only device in the sense that it automatically processes BIA measurements to output body composition parameters. The study involves comparing its outputs ("whole body BIA") to "in house BIA and DEXA reference" measurements, meaning its performance is evaluated directly against a reference standard without human interpretation as part of the primary measurement.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used is DEXA (Dual-energy X-ray absorptiometry) reference. The document states "in house BIA and DEXA reference" as part of its analytical method. DEXA is widely considered a gold standard for body composition analysis, providing highly accurate measurements of bone mineral density, lean soft tissue mass, and fat mass.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. While it mentions "in house BIA and DEXA reference" for the analytical method, it doesn't differentiate between data used for model development/training and data used for testing/validation.

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

The document implies that the ground truth for establishing the algorithms (which would be analogous to a training set for model development) was established using "in house BIA and DEXA reference." This means that the device's impedance measurements were correlated with and validated against highly accurate DEXA measurements to develop and refine the equations used to estimate various body composition parameters. This process would typically involve a dataset where subjects undergo both BIA measurements with the device and DEXA scans, with the DEXA results serving as the ground truth.

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MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350: A body composition analyzer that measures body weight and impedance and estimates body fat percent. BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis). MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001: A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).

The TANITA Body Fat Monitor/Scales (multiple models) are designed to determine body weight and body fat composition. Each model will offer a range of features. The system consists of two subdivided stainless steel footpad electrodes mounted on a platform scale. The four-foot electrodes are designed where each foot makes contact with a heel and toe electrode. Impedance of the lower extremities and body weight is measured simultaneously while the subject stands on the scale.

The provided text describes a 510(k) submission for TANITA Body Fat Analyzer TBF/BF/Ultimate Scale devices, asserting their substantial equivalence to a predicate device (TANITA Body Fat Analyzer Model TBF-105 K930599). However, it does not contain the detailed information necessary to fully answer all components of your request regarding acceptance criteria and the specific study proving the device meets those criteria.

The document largely focuses on establishing substantial equivalence based on the intended use, product description, and analytical method used, rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many sections below will indicate that the information is "Not provided in the document."

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not provided in the document. The document refers to "results of using the previously approved 'Foot-to-Foot' BIA methodology with our patented in-house BIA" but does not specify a sample size for any comparative study.
   • Data Provenance: Not provided in the document.

2. 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 applicable/Not provided. This device is a body composition analyzer. The "ground truth" would likely refer to a reference method (like DEXA or hydrostatic weighing) not expert consensus. The use of "DEXA reference methods" is mentioned, but without details on how it was applied or the expertise involved in its application for the study.

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

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers reviewing medical images or data. For a device like a body fat analyzer, the "ground truth" establishment would typically involve a reference measurement method rather than expert adjudication.

4. 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. This device is a standalone body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.

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

   • Yes, implicitly. The comparison describes the performance of the device itself (the "algorithm only," in a sense, as it performs the BIA measurement and calculation) against its predicate. The conclusion states, "the TANITA Body Fat Analyzer(s) TBF/BF/Ultimate Scales perform as well as the predicate device," which suggests an evaluation of the device's inherent measurement capabilities. However, specific standalone performance metrics are not given, only the assertion of equivalence.

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

   • The document mentions "DEXA reference methods" as part of the analytical method/measurement for both the predicate and applicant device. This implies that DEXA (Dual-energy X-ray Absorptiometry), a widely accepted reference method for body composition, would be the primary type of "ground truth" or reference standard if a direct comparison study was performed. However, no specific study results using DEXA as ground truth are presented.

7. The sample size for the training set

   • Not applicable/Not provided. This document describes a medical device, not a machine learning model that would typically have a specific training set. The BIA methodology is physics-based, not learned from data in the same way an AI algorithm is a "training set" in the context of deep learning. While calibration data might exist, it's not referred to as a "training set" here.

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

   • Not applicable/Not provided, as there is no mention of a "training set" in the context of an AI/ML model. If "training set" refers to calibration data or development data, the document does not elaborate on how ground truth was established for that data, other than mentioning "patented in-house BIA and DEXA reference methods."

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