(116 days)
For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, Body Mass Index (BMI),and Impedance Values
InBody 3.0 is an impedance plethysmograph body composition analyzer. The device determines body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components.
The provided text does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in a quantitative sense (e.g., sensitivity, specificity, accuracy targets). Instead, it's a 510(k) summary for a medical device (InBody 3.0 Body Composition Analyzer) seeking substantial equivalence to existing legally marketed devices.
The "study" referenced in the document is a comparison to predicate devices, where the new device is deemed "as safe and effective as the predicate devices" based on "bench and clinical testing." However, the details of these tests, including specific performance metrics and acceptance criteria, are not provided.
Here's an attempt to answer the questions based on the available information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria (e.g., specific accuracy ranges, correlation coefficients, or sensitivity/specificity thresholds) and corresponding reported performance values for the InBody 3.0 are provided in the document. The document states that "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," implying that its performance is comparable to the predicate devices, but without specifying how that "safety and effectiveness" was measured or what values constitute "safe and effective."
2. Sample sized 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 filing mentions "clinical testing" but does not detail the sample size, study design (retrospective/prospective), or data 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. Given that the device measures body composition parameters, the "ground truth" would likely involve reference methods for body composition (e.g., DEXA, hydrostatic weighing), rather than expert interpretation of images.
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 the InBody 3.0 Body Composition Analyzer. This device is an automated measurement tool for body composition, not an AI-assisted diagnostic imaging tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The InBody 3.0 is a standalone device that performs measurements directly. Its performance would inherently be "standalone." However, specific quantitative performance metrics (e.g., accuracy against a gold standard) are not reported in this summary. The assessment of "safety and effectiveness" against predicate devices implies standalone comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for "clinical testing." For body composition analyzers, common ground truth methods include:
- Dual-energy X-ray absorptiometry (DEXA)
- Hydrostatic weighing (underwater weighing)
- Isotope dilution
- Air displacement plethysmography (Bod Pod)
It is highly probable that one or more of these established methods were used, but the document does not specify.
8. The sample size for the training set
This information is not provided in the document. The device uses Bioelectrical Impedance Analysis (BIA), which relies on established physiological models and algorithms. While these models are developed and potentially trained on various populations, the specific training set size for this particular device's algorithms is not disclosed in the 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided in the document. Similar to the test set, any "training" (model development) for the BIA algorithms would have utilized established bodily composition measurement techniques, but the specifics are not detailed.
§ 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.