(157 days)
For use only in healthy subjects for Measurement of: Estimated: Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity, Visceral Fat Area (VFA). Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function].
InBodyS10, InBodyl70, and InBodyJ30 are impedance plethysmograph body composition analyzers. These devices determine 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 bighly 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.
This 510(k) summary (K110689) indicates that the Biospace Body Composition Analyzers (InBodyS10, InBody170, InBodyJ30) are substantially equivalent to predicate devices based on "bench and software testing." However, it does not provide details about specific acceptance criteria or the study that definitively proves the device meets those criteria. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with explicit acceptance criteria and results for the new devices.
Here's a breakdown of what is and isn't present in the provided text regarding your request:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document states, "The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device," but it does not present a table of specific acceptance criteria (e.g., accuracy +/- X%, precision Y%) or the quantitative performance measurements of the new devices against those criteria. The comparative table primarily focuses on features and measured parameters rather than performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. Neither the sample size nor the data provenance (country, retrospective/prospective) for any test sets are mentioned.
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)
- Not provided. There is no mention of experts or their qualifications for establishing ground truth. The document indicates that for "Visceral Fat Area (VFA)," evaluation was done "with CT," implying CT scans were used as a reference, but it doesn't describe the process of establishing ground truth from these CT scans or involving human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. As no details of a test set or ground truth establishment by experts are given, no adjudication method is mentioned.
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
- Not applicable/Not provided. This device is a body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied but not detailed. The device is an impedance plethysmograph body composition analyzer. It "determines body composition parameters based on bioelectrical impedance analysis (BIA)." This implies a standalone algorithm (the BIA analysis) calculates the parameters. However, no specific standalone performance study details (metrics, datasets) are provided beyond the general statement of "bench and software testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied for VFA, otherwise not specified. For "Visceral Fat Area (VFA)," the document states "Evaluation with CT." This suggests CT scans were used as a reference standard (ground truth) for VFA measurements. For other parameters (e.g., Skeletal Muscle Mass, Body Fat, Total Body Water), the type of ground truth used for validation is not specified.
8. The sample size for the training set
- Not provided. There is no mention of a training set or its sample size. The document's purpose is a 510(k) summary for substantial equivalence, which often doesn't require detailed descriptions of training data for such devices unless significant machine learning or AI algorithm development is a core differentiating factor.
9. How the ground truth for the training set was established
- Not provided. As no training set is mentioned, naturally, how its ground truth was established is also not provided.
In summary:
This 510(k) summary establishes substantial equivalence by comparing the new devices' features and measurement capabilities to previously cleared predicate devices. It states that "bench and software testing indicates that the new devices are as safe and effective as the predicate device," but it lacks detailed performance study information, including specific acceptance criteria, quantitative results, sample sizes, expert qualifications, or detailed ground truth methodologies that would typically be associated with a "study that proves the device meets the acceptance criteria." For devices like these, the substantial equivalence argument often relies on the proven safety and effectiveness of the existing predicate device and demonstrating that the new device operates on the same principles and provides comparable measurements.
§ 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.