(272 days)
The TANITA family of InnerScan Body Composition Monitors measure body weight and impedance and estimate percentage of body fat and body water, visceral fat rating, bone mass, muscle mass, physique rating, daily calorie intake (DCI) and metabolic age using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 7-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
The TANITA InnerScan Body Composition Monitor is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent, body water percent, muscle mass, bone mass, visceral fat rating, metabolic age, physique rating and daily calorie intake.
The provided text is a 510(k) summary for the TANITA InnerScan Body Composition Monitor. It establishes substantial equivalence by comparing it to predicate devices. However, it does not include detailed information about specific acceptance criteria for performance metrics, nor does it describe a study specifically designed to prove the device meets those criteria with statistical rigor.
Instead, the submission relies on the established "Foot-to-Foot" BIA methodology, which was used in the predicate devices, and states that the InnerScan monitor "performs as well as the predicate devices and therefore have proven its safety and efficacy." This is a common approach in 510(k) submissions, where substantial equivalence often hinges on similar technology and intended use, rather than presenting new, detailed performance studies with explicit acceptance criteria.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's a breakdown of what can be inferred or stated as missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary asserts that the device "performs as well as the predicate devices" based on the established BIA methodology, but it does not specify quantitative acceptance criteria (e.g., "accuracy of X% +/- Y kg") or report specific performance values for the InnerScan device against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "in-house BIA," "DEXA reference methods," "Deuterium Dilution and MRI reference methods" were used as analytical/measurement techniques, but it doesn't describe specific test sets, their sizes, or provenance.
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)
This information is not provided in the document. The 510(k) relies on reference methods like DEXA, Deuterium Dilution, and MRI, which are considered objective measurements for body composition. It does not mention human experts establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is described.
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
This is not applicable to this device. The TANITA InnerScan Body Composition Monitor is a standalone device that provides direct measurements and estimations of body composition. It is not an AI-assisted diagnostic tool that aids human readers (e.g., radiologists interpreting images).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone algorithm (BIA methodology) that provides body composition measurements. The submission focuses on the performance of this system without human intervention in the measurement process, but it doesn't detail a specific "standalone performance study" in the modern sense of algorithm evaluation against a ground truth dataset with reported metrics. Its performance is implicitly compared to predicate devices using the same fundamental methodology.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions several reference methods that serve as a form of "ground truth" or highly accurate measurement techniques:
- DEXA (Dual-energy X-ray absorptiometry): A widely accepted clinical standard for body composition.
- Deuterium Dilution: A method for measuring total body water, which can be used to estimate body composition.
- MRI (Magnetic Resonance Imaging): Can be used to assess body fat distribution and muscle mass.
These are considered objective, quantitative body composition assessment methods.
8. The sample size for the training set
This information is not provided in the document. The BIA methodology is described as "patented in-house BIA," implying it's based on internal development, but details about training data are absent.
9. How the ground truth for the training set was established
This information is not provided in the document. While reference methods like DEXA, Deuterium Dilution, and MRI are mentioned, the document does not elaborate on how these were used to establish ground truth for any training data that might have been used to develop the "in-house BIA."
§ 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.