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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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The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.

The TANTA Ironman Innerscan Body Composition Monitor BC-558 are a computer-operated body composition analyzer that utilizes BlA (bigledrical impedance analysis) to determine body fat percent, muscle mass, bone weight, visceral fat rating, Basal Metabolic Rate (BMR), metabolism age, physique rating, daily calorie intake (DCI), body water percent and segmental fat percent.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds the device needed to meet. Instead, it relies on a comparison to predicate devices, asserting "substantial equivalence." The "Predicate Devices" section in the summary provides a side-by-side comparison of specifications and functions, implying that matching or exceeding these characteristics (particularly for the new functionalities) constituted meeting the "acceptance criteria" for substantial equivalence.

Since precise quantitative acceptance criteria are not given, the table below will present the comparative specifications as performance indicators for the subject device (BC-558) and its predicates.

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

• Sample Size: This document does not specify a sample size for any test set. It refers to "the results of using the previously approved BIA methodology with our whole body BIA," suggesting general validation, but no specific number of subjects is mentioned for a test set.
• Data Provenance: Not specified. There is no mention of the country of origin or whether the data was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified. The document does not describe any expert adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The evaluation is based on "substantial equivalence" to predicate devices and the performance of the BIA methodology itself, not on human-in-the-loop performance.
• Effect size of improvement: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

• Was it done?: Yes, implicitly. The document states, "Based on the results of using the previously approved BIA methodology with our whole body BIA, it was concluded that the TANITA Ironman Innerscan Body Composition Monitor BC-558 performs as well as the predicate devices and therefore have proven its safety and efficacy." This indicates that the device's algorithmic performance in estimating body composition was evaluated in comparison to the established BIA methodology and predicate devices. However, details of this standalone performance are limited to the comparative specifications provided.

7. Type of Ground Truth Used

• The document states the analytical method for the BC-558 and its predicates uses "In house BIA and DXEA reference" or "In house BIA and DXEA/Deuterium Dilution reference."
  • DXEA (Dual-energy X-ray absorptiometry): This is a widely accepted and highly accurate method for measuring body composition (bone mineral density, fat mass, and lean mass) and is considered a "gold standard" for body composition analysis in research and clinical settings.
  • Deuterium Dilution: Another reference method, particularly for total body water, which can be used to derive fat-free mass.
  • Therefore, the ground truth used appears to be objective reference methods (DXEA, Deuterium Dilution), which are considered highly accurate and reliable measures of body composition.

8. Sample Size for the Training Set

• Not specified. The document does not provide details about a specific training set or its size. The device likely relies on algorithms and equations derived from extensive prior research and data (implied by "previously approved BIA methodology"), rather than a newly trained model for this specific submission.

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

• Not specified. Given the reliance on "previously approved BIA methodology" and "in house BIA and DXEA reference," it is inferred that the underlying BIA algorithms and their derived equations were developed and validated using data where ground truth was established by highly accurate methods like DXEA and potentially Deuterium Dilution. However, the specific process for the training set of this particular device (if a separate training phase was conducted beyond the general BIA methodology development) is not described.

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