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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), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Body Shape Graph

Actual: Weight [except for Model InBodyS10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S10 and InBody H20/InBody H20® which requires the manual entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [for InBody 510], Phase Angle [for InBody770, InBody S10] The InBody H20 and the InBody H20(B) are identical except that the (B) model has Bluetooth capability for data transfer.

InBody770, InBody570, InBody H20/InBody H20%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 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. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water; extra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue. The InBody H2O and the InBody H20() are identical except that the (5) model has Bluetooth capability for data transfer.

The provided 510(k) summary describes a comparative performance study rather than a study with pre-defined acceptance criteria against a ground truth. The primary goal of these studies was to demonstrate substantial equivalence to predicate devices, not to meet specific performance targets with absolute metrics like sensitivity or specificity.

Here's a breakdown of the available information based on your request, with explicit notes where the requested information is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state numerical acceptance criteria for performance metrics. Instead, the "acceptance" was based on demonstrating comparable performance to the predicate devices (InBody J30, InBody 170, InBody 3.0) through comparison tests. The conclusion states: "As compared to our predicate devices (our own brand) these new models have very similar technological characteristics and performed comparably to our predicates."

Reported Device Performance:
The document does not provide quantitative performance results (e.g., accuracy, precision measurements) for the new devices or their comparison to the predicate devices. It simply states that "comparison performance tests" were conducted and that the new devices "performed comparably."

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

• InBody570 vs. InBody J30: 68 examinees for the comparison test.
• InBody770 vs. InBody J30: 40 examinees for the comparison test.
• InBody S10 vs. InBody3.0: 43 examinees for the comparison test.
• InBody H20/InBody H20(B) vs. InBody J30: 40 examinees for the comparison test.

Data Provenance: The document does not specify the country of origin of the data nor whether the study was retrospective or prospective.

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

Not applicable. The studies described are comparison performance tests against a legally marketed predicate device (InBody J30, InBody 170, InBody 3.0), not against an independently established "ground truth" using experts. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. Since the studies are comparison performance tests against a predicate device, there is no mention of an adjudication method in the context of expert consensus or labeling of cases, as would be common in diagnostic imaging studies.

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. This device is an Impedance Plethysmograph (Body Composition Analyzer) that directly measures and estimates body composition parameters. It is not an AI-assisted diagnostic imaging device that human readers would interpret. Therefore, an MRMC study with human readers and AI assistance is not relevant to this device.

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

The device itself is a standalone measurement system. The clinical performance tests conducted were effectively "standalone" in the sense that they evaluated the device's output against a reference device, without human interpretation as part of the primary output. The device generates estimated body composition parameters directly.

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

For the described clinical performance tests, the "ground truth" was the measurements obtained from the legally marketed predicate devices (Biospace Body Composition Analyzer Model InBody J30, InBody 170, InBody 3.0). The study aim was to demonstrate "comparable performance" to these predicates, not to an independent gold standard like DEXA or hydrostatic weighing.

8. The Sample Size for the Training Set

Not applicable. The document describes clinical performance validation studies performed to demonstrate substantial equivalence, not the development or training of an algorithm. There is no information provided about a "training set" for the underlying bioelectrical impedance analysis (BIA) algorithms used by the InBody devices. These algorithms are based on scientific principles and likely developed over time, not typically "trained" on a dataset in the way a modern machine learning model would be.

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

Not applicable. As mentioned in point 8, the document does not describe a training set or the establishment of ground truth for it. The BIA technology relies on established physiological models and electrical properties of tissues. The derivation of "Segmental Body Water" is mentioned as being "based on a computation that is Segmental Body Water is calculated using Segmental Lean Mass supported by reference papers: that is already submitted in InBody J30 (K110689). Body Water can be calculated by Lean Body Mass (= Fat Free Mass) according to fact which is founded in the attached reference papers. As in papers they tell body water/fat free mass is 0.73." This indicates reliance on scientific literature and prior device approvals rather than a new "training set" with established ground truth.

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