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For use only in healthy subjects for Measurement of:

Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ICW), Total Body Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Shape Graph, Weight Control, Fat Control, Muscle Control, Segmental ECW/TBW, Segmental ICW, TBW/LBM, Leg Lean Mass, Fitness Score, AC (Arm Circumference)

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody S10], Reactance Values [only for InBody770, InBody S10], Phase Angle [only for InBody770, InBody S10]

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), 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.
These devices 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 Biospace Body Composition Analyzers (Models InBody770, InBody570, InBody S10, InBody230) were evaluated through a clinical study to demonstrate substantial equivalence to previously cleared predicate devices. The primary method of evaluation involved comparing the performance of the new devices against predicate devices across a range of body composition metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating comparable performance to predicate devices already cleared by the FDA, with "very nearly 1.00" correlation coefficients between the new devices and predicates as the key performance indicator.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Approximately 80 patients.
• Data Provenance: The document does not explicitly state the country of origin. Given Biospace Corporation Limited is based in Seoul, Korea, it is highly probable the data originated from Korea. The study appears to be prospective as it states "We conducted clinical testing on each model."

3. Number and Qualifications of Experts for Ground Truth:

The document does not mention using experts to establish ground truth for the test set in the traditional sense (e.g., radiologists interpreting images). The study focuses on comparing the output of the new devices against predicate devices, implying that the predicate devices themselves serve as a form of "reference" or "ground truth" for comparative effectiveness in this context.

4. Adjudication Method:

Given that the ground truth appears to be based on the output of predicate devices, an adjudication method in the form of expert consensus is not applicable or mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted as this device does not involve human readers interpreting diagnostic images. The study compared device outputs directly. Therefore, there is no effect size of human improvement with or without AI assistance to report.

6. Standalone Performance Study:

A standalone performance study of the algorithm (if "algorithm" refers to the core BIA calculation logic) was implicitly done in the context of comparing the new devices against predicates. The reported "very nearly 1.00" correlation coefficients represent the standalone performance of the new devices relative to the established performance of the predicate devices. The study compares the device's measurement capabilities rather than an AI algorithm without human intervention.

7. Type of Ground Truth Used:

The primary "ground truth" for comparison was the measurements obtained from predicate devices. This is a form of comparative validation against established medical devices with a known performance profile.

8. Sample Size for the Training Set:

The document does not provide information regarding a separate training set or its sample size. As a medical device based on bioelectrical impedance analysis, its underlying principles and algorithms might be well-established, potentially requiring calibration and validation rather than extensive machine learning-style "training" on a specific dataset for output generation in the same way an AI image classification model would.

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

As no explicit training set is mentioned in the provided text, the method for establishing its ground truth is not discussed.

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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 Fat Mass, % Segmental · Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody720], Reactance Values [only for InBody720], Phase Angle fonly for InBody720]

These devices 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), 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 provided document describes the Biospace Body Composition Analyzers (Models InBody 120, InBody 370, InBody 720, InBody 520) which are impedance plethysmograph body composition analyzers. The study conducted for these devices aimed to prove their substantial equivalence to their predicate devices, rather than establishing specific quantitative acceptance criteria for their performance. The acceptance criteria for these devices, as implied by the FDA 510(k) summary, is that their clinical performance is comparable to that of legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that "proves" the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy percentages, standard deviations) that the device must achieve. Instead, the "acceptance criteria" appear to be based on demonstrating clinical performance comparable to predicate devices. The reported device performance is therefore framed in terms of this comparability.

2. Sample Sizes used for the test set and data provenance

• InBody 120: 39 examinees
• InBody 370: 88 examinees
• InBody 520: 75 examinees
• InBody 720: 62 examinees
• Data Provenance: The studies were conducted at unknown locations but by "Biospace Corporation Limited" (KOREA). The timeframe for the studies are indicated:
  • InBody 120: August 19th - August 23rd, 2012
  • InBody 370: September 3rd - September 5th, 2012
  • InBody 520: July 2nd - July 4th, 2010
  • InBody 720: July 2nd - July 4th, 2010
• Retrospective/Prospective: The studies are described as "comparison performance tests" conducted with "groups of examinees" during specific dates. This suggests they were prospective studies where data was collected specifically for validation purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set

The document does not specify any adjudication method for the test set. Given that these are bioelectrical impedance analysis devices, the "ground truth" would likely come from other established body composition measurement methods (e.g., DEXA, hydrostatic weighing), not from expert consensus or adjudication of subjective interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The clinical studies were "comparison performance tests" between the new devices and predicate devices on groups of examinees. These are standalone device comparisons, not focused on human reader performance with or without AI assistance.

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

Yes, the studies described are, by nature, standalone performance evaluations. The devices are body composition analyzers, and their measurement outputs are compared to the predicate devices. There is no human-in-the-loop component described for the measurement process itself, other than the subject operating the device as intended. The "clinical performance" test directly evaluates the algorithm (and hardware) of the new device against the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the method used for "ground truth" during the comparison studies. However, in the context of bioelectrical impedance analysis, the "ground truth" would typically come from a more established or reference method for body composition measurement (e.g., Dual-energy X-ray absorptiometry (DEXA), hydrostatic weighing, isotopic dilution). The comparison itself is made against a "predicate device" which is already legally marketed and presumed to provide accurate measurements. Therefore, the predicate device itself serves as a proxy for "ground truth" in these comparison studies.

8. The sample size for the training set

The document does not provide any information about a "training set" or its sample size. These devices use bioelectrical impedance analysis (BIA), which relies on established physiological models and algorithms, likely developed and validated over time. The submission focuses on demonstrating equivalence to predicates, implying the core algorithms are already established, rather than presenting a de novo AI development requiring a specific training set validation.

9. How the ground truth for the training set was established

As no training set is mentioned, there is no information provided on how its ground truth might have been established.

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