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BC is a software accessory for RJL Systems Quantum-X, Quantum Desktop, and Quantum-III. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-III analyzers, the computer must have an available serial port.

Indications for Use:

Calculation and Historical Tracking of:

• Actual Impedance .
• Actual Phase Angle (PA) .
• Estimated Body Fat (FAT) .
• Estimated Fat Free Mass (FFM) .
• . Estimated Total Body Water (TBW)
• Estimated Intra-Cellular Water (ICW) ●
• Estimated Extra-Cellular Water (ECW) ●
• Estimated Basal Metabolic Rate (BMR) .
• Estimated Daily Energy Expenditure (DEE) .
• Actual Body Mass Index (BMI) .

BC is intended only for use on normally healthy adults and adolescents age 9-94.

The BC application is intended to be used as a software accessory to RJL Systems' existing line of Bio-Impedance Analyzers ( K830292 and K862383 ). The user obtains values for the Resistance and Reactance of an individual, and enters these numbers, along with the individual's name, age, height, weight, gender, activity level, frame size, and optionally, subject ID and desired target weight. These values are stored in a database to enable historical tracking, and are then used in a series of prediction equations to estimate the parameters listed above.

For estimating body composition parameters, the BC application relies on prediction equations developed as the result of clinical studies. The user is provided the opportunity to select from several different sets of equations, each assembled from one or more studies. References are provided for every set of equations, except for those contained in the original RJL BIA-103 device software.

The BC application is non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition.

The provided 510(k) summary for the "BC body composition software" does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic device.

Instead, the submission focuses on substantial equivalence to predicate devices based on its indications for use and general functional equivalence. There are no detailed acceptance criteria or a dedicated study with performance metrics in the provided text.

Here's a breakdown of the requested information based on the available text:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds for accuracy, sensitivity, specificity, or other performance metrics. The acceptance is based on the device's functional equivalence to predicate devices and its ability to calculate and track the listed body composition parameters.

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not describe a specific "test set" or a separate clinical study with a defined sample size for the BC software itself. It mentions that the "prediction equations developed as the result of clinical studies" are used. However, it does not provide details on these underlying studies' sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no specific test set described for the BC software itself where experts established ground truth. The "prediction equations" are referred to as being from "clinical studies," but no details about these studies or expert involvement are provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is described.

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 a software accessory for body composition analysis; it does not involve human readers interpreting medical images or data that would typically be part of an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a "software accessory" that takes input from Bio-Impedance Analyzers and user-entered data (name, age, height, weight, gender, activity level, frame size). It then applies prediction equations. While the calculations are algorithm-only, the setup inherently has a "human-in-the-loop" for data entry and selection of equations. There is no standalone performance study described for the software's accuracy against a ground truth. Its performance is tied to the validity of the selected prediction equations, which are from other "clinical studies" not detailed here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states the BC application "relies on prediction equations developed as the result of clinical studies." For these underlying studies that generated the prediction equations, the "ground truth" for body composition parameters would typically be established using methods like:

• DEXA (Dual-energy X-ray absorptiometry): A gold standard for body composition.
• Hydrostatic weighing: Another common validation method.
• Isotope dilution (for TBW): For accurate total body water measurements.
• Anthropometric measurements combined with other techniques: Depending on the specific parameter.
  However, the document for the BC software does not specify the ground truth used in the original clinical studies that developed the prediction equations.

8. The sample size for the training set:
Not applicable for the BC software itself. The BC software utilizes pre-existing prediction equations. The sample sizes for the training sets of those underlying prediction equations are not provided in this 510(k) summary.

9. How the ground truth for the training set was established:
Not applicable for the BC software itself. As above, the ground truth establishment for the training sets of the underlying prediction equations is not detailed in this document.

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The BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.

The proposed Athletic IQ, Inc. (AIQ) BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old. The device determines estimated body fat percentage 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, whereas fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA permits differentiation of fat vs. lean tissue. When combined with the subject's height and weight parameters, age, and gender, an estimated body fat percentage may be calculated using an experimentally derived algorithm.

The provided text states that "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data." However, it does not provide details on the acceptance criteria, the specific study design, or the results of this clinical testing. Therefore, I cannot construct the requested tables or provide detailed answers to many of your questions based only on the provided text.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not specified in the provided text.
• Reported Device Performance: Not specified in the provided text, beyond the general statement that "Clinical testing was conducted to establish the algorithm."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (country of origin, retrospective/prospective).

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 specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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 specified. This device is a diagnostic tool, not an AI-assisted interpretation tool for human readers. It directly provides an estimated body fat percentage.

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

• Yes, implicitly. The device "determines estimated body fat percentage based on bioelectrical impedance analysis (BIA)" and calculates it "using an experimentally derived algorithm." This indicates a standalone algorithm performance without human intervention in the result generation. However, the performance metrics for this standalone algorithm are not provided.

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

• Not specified. For body fat analysis, a common ground truth method would be DEXA (Dual-energy X-ray absorptiometry) or hydrostatic weighing, but the text does not mention the method used.

8. The sample size for the training set

• Not specified. The text mentions "an experimentally derived algorithm," implying a training set was used, but no details are given.

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

• Not specified.

Summary of what is known from the provided text:

• Device Name: BC100 Body Composition Analysis System
• Intended Use: Noninvasive bioimpedance analyzer for measurement of actual height, actual weight, and estimated body fat percentage in healthy subjects aged 10-80 years old.
• Technology: Bioelectrical Impedance Analysis (BIA) combined with subject's height, weight, age, and gender, using an experimentally derived algorithm.
• Performance Claim: "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data."
• Regulatory Conclusion: Found "safe and effective for its intended use" based on this clinical testing and comparison to predicate devices.

Missing Information:

Crucially, the provided 510(k) summary and FDA letter do not contain the detailed clinical study results, acceptance criteria, or sample sizes that would allow for a comprehensive answer to your request. These details are typically found in the full 510(k) submission, not necessarily in the summary or clearance letter.

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A body composition analyzer and a software package that will estimate display and store the following body composition parameters:

Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICVV), I Fut noo Mass (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). Extra octualiar vialer (2 x 77), voltage and phase angle (Phi), and from these values calculates The device moductions our only ready which are used to estimate the above body resistance (1), roustanto (1), roustanto (1), also display the user's height, weight, age, % oompoolion parameter of measurement, Practitioner's name and Device serial number.

This device is intended for use on healthy children (9 - 16 years old), general and obese adult rubjects, only for body composition assessment in the home or clinical environment.

The Imp DF50 is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water, intracellular water, and extracellular water.

The ImpediMed Imp DF50 Body Composition Analyzer is a battery powered, accurate, handheld, single frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.

Bioelectrical impedance analysis measures the impedance or opposition to the flow of an electric current through the body fluids contained mainly in the lean and fat tissue. Impedance is low in lean tissue, where intracellular fluid and electrolytes are primarily contained, but high in fat tissue. Impedance is thus related to total body water volume. In practice, a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed frequency of 50 kHz± 100Hz is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes provides a measure of impedance. The performance of the device may be checked with the aid of a calibration circuit (supplied as an accessory) for quality assurance or servicing purposes.

Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration for lean tissue. Fat mass is subsequently calculated as the difference between body weight and lean body mass.

The provided text does not contain detailed information about specific acceptance criteria or a study proving that the ImpediMed Imp DF50 Body Composition Analysis device meets these criteria. The document is primarily a 510(k) summary for regulatory submission, focusing on device identification, intended use, technological characteristics, and substantial equivalence to predicate devices. It does not include performance data, study designs, sample sizes, or ground truth establishment relevant to acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. The document mentions that the device "accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance," and that "Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW." However, it does not detail the specific studies, their methodologies, or the performance metrics achieved against predefined acceptance criteria.

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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, 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.

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