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The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition.

The provided text describes the "Scaleman Body Fat Scales" and its substantial equivalence to a predicate device, the "Tanita Innerscan Body Composition Monitor, K040778". However, it does not clearly define specific acceptance criteria in a quantitative manner or provide a detailed study that explicitly proves the device meets such criteria with numerical performance data.

Instead, the document states: "A comparative clinical study, submitted in this notification (Section 20), showed that body fat (%) and FFM (kg) in normal and athlete modes, body water (%) muscle mass (kg), bone mass (kg) and weight (kg) measured or estimated by test and predicate devices were significantly correlated (P<. 05)." This indicates that the study focused on correlation with a predicate device, rather than explicit acceptance thresholds (e.g., accuracy within X% against a gold standard).

Given this limitation, I will extract the available information and structure it to best answer your questions based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide explicit numerical acceptance criteria or detailed performance metrics beyond a statement of "significant correlation." The table below reflects the information available within the text.

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

• Sample Size for Test Set: Not specified in the provided text. The document only mentions "A comparative clinical study."
• Data Provenance: Not specified in the provided text. (e.g., country of origin, retrospective or prospective)

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

• Number of Experts: Not applicable. The ground truth appears to be based on correlation with a predicate device, not expert consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or specified. The study relied on comparing measurements from the test device to those of a predicate device.

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

• MRMC Study: No, an MRMC study was not done. The device is a body composition analyzer, not an imaging device requiring human reader interpretation. No human-in-the-loop performance is mentioned or implied.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: Yes, the described study evaluates the standalone performance of the Scaleman Body Fat Scales by comparing its measurements directly to those of a predicate device. There is no indication of human intervention in the measurement or interpretation process for the device itself.

7. The type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the comparative clinical study was established by the measurements from the predicate device (Tanita Innerscan Body Composition Monitor, K040778). The study aimed to show "significant correlation" between the test device and this predicate. This is a form of comparative effectiveness against a legally marketed device rather than an absolute gold standard (e.g., DEXA for body fat).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document does not describe the development or training of the BIA algorithm itself, only the clinical comparison to a predicate device.

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

• Ground Truth for Training Set: Not specified. The document focuses on the clinical performance study for regulatory submission, not the initial development or training data for the BIA algorithm.

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