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Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.

The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.

The Conmo Electronic Company Limited Body Fat Analyzer and Scale, Model 5786, measures body weight and impedance and estimates the percentage of body fat, body water, and body muscle mass using Bioelectrical Impedance Analysis (BIA). The provided 510(k) summary states that clinical testing was used to validate the effectiveness and accuracy of the device, with all test results reported as satisfactory. However, the document does not explicitly detail specific acceptance criteria or the study design (e.g., sample size, expert involvement, ground truth methodology) for this clinical testing.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state specific numerical acceptance criteria for accuracy, precision, or other performance metrics. It only states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." Without specific criteria, a direct comparison is not possible.

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

• Sample Size for Test Set: Not specified
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical testing."

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

• Number of Experts: Not specified
• Qualifications of Experts: Not specified

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document does not provide details on how discrepancies in ground truth establishment (if any) were resolved.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or described in the document. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance to measure the effect size of AI improvement. The device in question is a standalone measurement device for body composition, not an AI-assisted diagnostic tool.

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

• Standalone Performance: While the device functions as a standalone unit (measurements are taken by the device and calculations performed by internal software), the document does not provide a detailed breakdown of a standalone performance study with specific metrics beyond the general statement of "satisfactory" effectiveness and accuracy. The clinical testing mentioned seems to assess the overall device performance which, by its nature, is standalone as it outputs direct measurements.

7. The Type of Ground Truth Used

• Type of Ground Truth: The document does not explicitly state the specific "ground truth" method used for the clinical validation of body fat, body water, or body muscle mass. For body composition devices, common ground truth methods include:
  • DEXA (Dual-energy X-ray absorptiometry): A gold standard for body composition.
  • Hydrostatic weighing: Another accurate method.
  • Air displacement plethysmography (Bod Pod): Also considered accurate.
  • Calipers: For skinfold thickness.
    Without this information, it's unclear against what highly accurate measurement the device's outputs were compared.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document describes a device that performs calculations based on Bioelectrical Impedance, height, weight, age, and gender using "internal software." It does not describe a machine learning or AI model that requires a distinct "training set" in the conventional sense. The "internal software" likely uses established BIA equations rather than a learned model from a large dataset.

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

• Ground Truth for Training Set: Not applicable/Not specified. As there is no mention of a training set for a machine learning model, the method for establishing ground truth for such a set is not relevant here. The device's calculations are based on programmed variables and scientific formulas for BIA.

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The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis).

The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.

The TANITA Body Composition Analyzer SC-331 is a composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body mass index (BMI), total body fat percent, total body water percent and weight, muscle (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.

This document focuses on the Tanita Body Composition Analyzer Model SC-331, a device that uses Bioelectrical Impedance Analysis (BIA) to measure and estimate various body composition parameters. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Tanita Body Composition Analyzer SC-331 are implicitly established by demonstrating substantial equivalence to its predicate devices (TANTA Body Fat Analyzer Professional and Consumer Models K014009 and K040778, and the TANITA Body Composition Analyzer: Model BC-53X).

The table directly from the 510(k) summary compares the specifications and indicated outputs of the SC-331 with its predicate devices. The "reported device performance" is the statement that the SC-331 "performs equivalently" to these predicate devices based on "the results of [its] whole body BIA."

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

The provided text does not explicitly state the sample size used for the test set. It mentions "the results of [TANITA's] whole body BIA" as the basis for performance claims.
The data provenance is not specified. It does not mention the country of origin of the data, nor whether it was retrospective or prospective. The term "in house BIA and DEXA reference" suggests internal validation data.

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

This information is not provided in the document. The statement "in house BIA and DEXA reference" for analytical method/measurement implies that DEXA (Dual-energy X-ray absorptiometry) was used as a reference standard, which is considered a gold standard for body composition. However, it does not specify how many experts, if any, were involved in generating or interpreting this ground truth data, nor their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done nor is it applicable to this device. This is a body composition analyzer, not an imaging analysis AI intended to assist human readers. The assessment is purely on the device's accuracy in measuring body composition parameters.

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

Yes, a standalone performance assessment was implicitly performed. The device itself, the TANITA Body Composition Analyzer SC-331, is an algorithm-only device in the sense that it automatically processes BIA measurements to output body composition parameters. The study involves comparing its outputs ("whole body BIA") to "in house BIA and DEXA reference" measurements, meaning its performance is evaluated directly against a reference standard without human interpretation as part of the primary measurement.

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

The type of ground truth used is DEXA (Dual-energy X-ray absorptiometry) reference. The document states "in house BIA and DEXA reference" as part of its analytical method. DEXA is widely considered a gold standard for body composition analysis, providing highly accurate measurements of bone mineral density, lean soft tissue mass, and fat mass.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. While it mentions "in house BIA and DEXA reference" for the analytical method, it doesn't differentiate between data used for model development/training and data used for testing/validation.

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

The document implies that the ground truth for establishing the algorithms (which would be analogous to a training set for model development) was established using "in house BIA and DEXA reference." This means that the device's impedance measurements were correlated with and validated against highly accurate DEXA measurements to develop and refine the equations used to estimate various body composition parameters. This process would typically involve a dataset where subjects undergo both BIA measurements with the device and DEXA scans, with the DEXA results serving as the ground truth.

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