(98 days)
A body composition analyzer that measures body weight and impedance and estimates percentage of body fat and body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.
The TANITA Scale plus Body Fat Monitor with Body Water Percentage is a computeroperated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat and body water percentage.
The provided text is a 510(k) summary for the TANITA Scale plus Body Fat Monitor with Body Water Percentage. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study for the applicant device. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and ground truth establishment is not present in the given document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision, bias) for body fat or body water percentage. Instead, it relies on a qualitative statement of substantial equivalence to predicate devices.
| Metric / Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantially equivalent to predicate devices (TANITA Body Fat Analyzer Professional and Consumer Models K014009) in determining weight, estimating body fat and total body water using BIA. | "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 Scale plus Body Fat Monitor with Body Water Percentage performs as well as the predicate devices." (This is a general statement of equivalency, not specific performance data). |
| New Total Body Water Algorithm | "Validation of the new total body water algorithm" (Implicitly, the algorithm should provide estimates comparable to established methods). | No specific performance metrics or results are provided for this validation, only that "No new tests were performed apart from the validation of the new total body water algorithm." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It mentions "in-house BIA and DEXA/Deuterium Dilution reference methods" which implies some form of testing was conducted, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 type of study is not applicable to this device. The device is a "Scale plus Body Fat Monitor" and directly measures/estimates body composition, it is not an AI-powered diagnostic tool requiring human reader interpretation in a medical imaging context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A direct "standalone" performance study with quantifiable results is not explicitly described. The closest indication is the "validation of the new total body water algorithm," but no details on this validation are provided. The general statement of performance is in comparison to predicate devices, implying performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "DEXA/Deuterium Dilution reference methods" as ground truth comparators.
- DEXA (Dual-energy X-ray absorptiometry) is a widely accepted, gold-standard method for measuring body composition (bone mineral density, lean soft tissue, and fat mass).
- Deuterium Dilution (D2O dilution method) is a reference method for determining total body water.
8. The sample size for the training set
This information is not provided in the document. The submission focuses on substantial equivalence based on a previously approved methodology and validation of a new algorithm, not on a machine learning model's training set.
9. How the ground truth for the training set was established
This information is not provided in the document, as it does not describe a machine learning model's training process.
§ 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.