(201 days)
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
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Puntative Acceptance Criteria based on predicate device equivalence | |
| Accuracy of Body Weight Measurement: (Implied, to be equivalent to predicate) | Not explicitly stated – the document asserts the new device "perform[s] as well as the predicate device" in determining body weight. No specific accuracy metrics (e.g., ±X kg, % deviation) are provided as acceptance criteria or reported performance for either the applicant or predicate device. |
| Accuracy of Body Fat Composition Estimation: (Implied, to be equivalent to predicate) | Not explicitly stated – the document asserts the new device "perform[s] as well as the predicate device" in estimating body fat composition. No specific accuracy metrics (e.g., correlation coefficient, mean absolute error, % agreement with DEXA) are provided as acceptance criteria or reported performance for either the applicant or predicate device. The document mentions "DEXA reference methods" in the analytical method description, suggesting DEXA might be used for comparison, but no results from such a comparison are presented. |
| Reproducibility/Precision of Measurements: (Implied, to be equivalent to predicate) | Not explicitly stated. |
| Safety and Efficacy: (General assertion for substantial equivalence) | The conclusion states: "Based on the results of using the previously approved "Foot-to-Foot" BIA methodology with our patented in-house BIA it was concluded that the TANITA Body Fat Analyzer(s) TBF/BF/Ultimate Scales perform as well as the predicate device and therefore have proven its safety and efficacy." No specific metrics or data are provided to substantiate this claim beyond the assertion of equivalence to the predicate, which itself is only described by its method. |
| Consistency with "Foot-to-Foot" BIA methodology & patented in-house BIA and DEXA reference methods | The document states both the predicate and applicant device utilize and are consistent with these methodologies. This is a characteristic of the analytical method rather than a specific performance metric, but successful implementation and consistency are implied. There are no results explicitly detailing how this consistency was confirmed or measured in a study, only that it was used and resulted in the conclusion of substantial equivalence. |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.