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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, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values

Models Inbody 520, Inbody 720, and Inbody S20 are body composition analyzers. The 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 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 K052646 document for Biospace Corporation Limited's InBody Body Composition Analyzers (Models 520, 720, and S20) does not contain detailed acceptance criteria, specific study designs, or reported device performance metrics as requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528) to obtain 510(k) clearance from the FDA.

The document indicates that "bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," but it does not provide the quantitative results or specific acceptance criteria for these tests. The comparison table primarily highlights the features and indications for use, including the different frequencies used for impedance measurements, between the new devices and the predicate.

Therefore, many of the requested details cannot be extracted directly from this document. Below is an attempt to address the points based on the available information and what can be inferred about a 510(k) submission for substantial equivalence.

Acceptance Criteria and Study for Biospace Body Composition Analyzers (Models InBody 520, InBody 720, and InBody S20)

The provided submission primarily focuses on demonstrating "substantial equivalence" to a predicate device, as opposed to establishing specific performance acceptance criteria and proving them through detailed studies with quantitative results. The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily that it meets pre-defined acceptance criteria for novel performance claims.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, explicit quantitative acceptance criteria and reported device performance metrics (e.g., accuracy, precision, correlation coefficients against a gold standard) are not detailed. The document generally states: "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices."

The comparison table (Section 6) focuses on functional equivalence, listing the Indications for Use and Analysis Method as identical to the predicate device, but expands the Operating parameters (Frequency) for the new models (InBody 720 and S20) compared to the predicate and InBody 520. This suggests that the "acceptance criteria" were likely related to demonstrating similar measurements and safety profiles to the predicate, rather than meeting specific numerical performance targets against a true gold standard.

Missing Information: The document does not provide actual numerical data for accuracy, precision, bias, correlation coefficients, or any other specific performance metrics from the bench or clinical testing mentioned.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. For a 510(k) submission based on substantial equivalence, clinical data might involve healthy volunteers to demonstrate comparable measurements to the predicate device, but specific sample sizes and data provenance (e.g., country of origin, retrospective/prospective nature) are not disclosed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Body composition analysis, especially with BIA, usually relies on reference methods (e.g., DEXA, hydrodensitometry) or other validated BIA devices rather than expert consensus on images. The "ground truth" for the test set would likely be measurements from the predicate device or a clinical gold standard, if such a study was performed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided. As the device measures quantitative physiological parameters rather than interpreting images or clinical signs, an adjudication method for "test set" interpretation is generally not applicable in the same way it would be for diagnostic imaging.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This information is not provided. MRMC studies are typically used in diagnostic imaging to assess human reader performance with and without AI assistance. This device is a quantitative measurement tool (body composition analyzer), not an imaging interpretation aid, so an MRMC study is highly unlikely to have been performed or relevant for this type of submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone algorithm/device for body composition analysis. The "performance" described would inherently be the algorithm's performance in providing measurements. The document generally states "bench and clinical testing," which implies direct performance evaluation of the device in a standalone capacity. No human-in-the-loop component is mentioned or suggested for the primary function of body composition measurement.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The specific type of "ground truth" used for any clinical testing (if conducted beyond direct comparison to the predicate) is not explicitly stated. However, for body composition analyzers like the InBody series, the ground truth typically involves:

• Validated Reference Methods: Such as Dual-energy X-ray Absorptiometry (DEXA), hydrodensitometry (underwater weighing), or isotope dilution for water compartments.
• Comparison to a Predicate Device: In a 510(k) context, a common approach is to demonstrate agreement with the legally marketed predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528) through correlation studies or Bland-Altman analysis.

Given the 510(k) pathway, it is most probable that comparability to the predicate device was the primary "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not provided. BIA devices typically use mathematical models and equations to convert impedance values into body composition parameters. While these models might be "trained" or derived from large population datasets, the details of such training sets (size, characteristics, data provenance) are not part of this 510(k) summary. This submission focuses on the performance of the device (applying its algorithms) rather than the development of the algorithms themselves.

9. How the Ground Truth for the Training Set was Established

This information is not provided. If mathematical models within the device's software were derived from population data, the ground truth for establishing those models would typically come from a combination of gold-standard body composition methods (e.g., DEXA, hydrodensitometry) applied to a diverse cohort. However, this level of detail is beyond the scope of this 510(k) submission, which assumes the underlying BIA principles and algorithms are already established or sufficiently similar to a predicate.

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