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The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only.

Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults).

Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old.

Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only.

The scales are not intended for diagnosis.

The Body Fat scales use BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat percent, muscle percent, body water percent, and bone percent. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.

The devices are single frequency electrical bio-impedance analyzer. All models measure current, voltage and phase angle, calculate impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition of: body fat percent, body water percent, muscle mass percent, bone mass percent, daily calories intake recommendation, and provides a fitness assessment. All models have a bi-polar set of contact electrodes which are attached to stainless steel pads on the platform of the analyzer.

The scales can store the personal data of up to 12 users. As well as being an analyzer, these devices can be used as a conventional scale. The models have one operating mode: Algorithm Mode.

Algorithm Mode; Displays estimates of body fat percent and body water percent. The devices compute these values using accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children.

The devices consist of a main unit having a glass or stainless steel platform for the user to step on. On the platform, 2 stainless steel electrodes are mounted which are connected to the electronics circuitry with the analyzing MCU. When the user steps on the electrodes (1 for each foot) a small current of about 90μA will pass through the user body through the 2 feet to complete the close circuitry in order for the analyzer to measure and capture the electrical data change in terms of Bio electrical impedance, resistance, reactance, taking into account other parameters as to personal data of Age, Height, Gender, and Weight.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not list specific, quantifiable acceptance criteria for the performance of the body fat scales (e.g., a specific delta or correlation coefficient for body fat percentage). Instead, the acceptance is based on a determination of substantial equivalence to a predicate device.

The reported device performance is that the "two scales provide substantially equivalent results."

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

• Sample Size for Test Set: 70 participants (50 adults and 20 children).
• Data Provenance: Not explicitly stated regarding country of origin. The study was conducted by the "sponsor," suggesting it was an internal study or sponsored by the manufacturer. It was a prospective study, as participants "standing on both the predicate scale and a Body Fat scale to obtain measureable parameters."

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

This information is not provided in the document. The study compares the performance of the subject device to a predicate device, not to an independent "ground truth" established by experts in the context of diagnostic accuracy. The "ground truth" in this performance study is the measurements obtained from the predicate device itself.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in scenarios where multiple experts are evaluating cases and their agreement or disagreement needs to be resolved to establish a definitive ground truth. In this study, the comparison is directly between two devices.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a direct comparison between a new device and a predicate device, not an evaluation of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone (algorithm only) performance assessment was done in the sense that the device's algorithms were compared to those of the predicate device. The text states:

• "The performance of Body Fat Scales was compared to the performance of the predicate device through testing conducted by the sponsor."
• "This testing consisted of 70 participants... standing on both the predicate scale and a Body Fat scale to obtain measureable parameters which are also used for algorithm calculations. This testing showed the two scales provide substantially equivalent results."

This indicates an evaluation of the device's algorithmic output (body composition estimations) in comparison to the predicate, without human intervention in the interpretation of the output for the purpose of the substantial equivalence claim.

7. Type of Ground Truth Used

The "ground truth" for the performance comparison was the measurements obtained from the predicate device (Tanita Model: SC331). The study aimed to show that the subject device produced results "substantially equivalent" to the predicate, making the predicate's output the de facto reference for this comparison. It was not pathology, outcomes data, or expert consensus in an absolute sense, but rather a comparative reference.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The device uses "accepted reviewed published algorithms," which suggests these algorithms were developed based on prior research and data, but the specific training data for these algorithms as applied to this device is not provided. The 70 participants were part of a comparative performance test to demonstrate equivalence.

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

Since a dedicated training set for the subject device is not described, the method for establishing its ground truth is also not provided. The algorithms are stated to be "accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children." This implies the underlying algorithms were developed and validated using standard, often clinically derived, methods for BIA calculation in the scientific literature. However, the specifics of this particular device's training data and its ground truth establishment are absent.

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