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The seca mBCA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages.

In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (FFM), Fat Mass (FM), Fat Mass Indices (FMI and FMMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis (BIVA), Energy stored in body (Ebody) and Phase Angle (Φ).

The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca analytics 115 for data management, calculations and display of information.

The seca mBCA 514 is a scale and impedance plethysmograph body composition analyzer for estimation of the body composition of individuals based on the Bioelectrical Impedance Analysis (BIA). The device measures bioelectrical impedance values by means of multi frequency, segmental measurements (right arm, trunk, right leg, left leg, right body side and left body side).

The seca mBCA 514 is a body composition analyzer that uses bioelectrical impedance analysis (BIA) to estimate body composition. The device's performance was evaluated through bench and clinical testing to demonstrate its safety and effectiveness compared to a predicate device, the BioSpace InBody 720 (K052646), and other established methods for specific body composition parameters.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific thresholds (e.g., a certain percentage of agreement or a specific correlation coefficient). Instead, it states that the results of the testing "demonstrate that the seca mBCA 514 is as safe and effective as the predicate device" and that the "differences with the predicate devices and methods are sufficiently minor to establish substantial equivalence." This implies that the acceptance criteria were met by demonstrating comparable performance to established methods.

Here's a summary of the comparisons:

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

The document does not explicitly state the specific sample size used for the test set in the clinical trials, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only broadly refers to "clinical testing."

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth for different parameters was established using established scientific methods (e.g., deuterium oxide dilution, sodium bromide dilution, DXA, BOD POD), rather than solely expert consensus on interpretations of device outputs.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by reference methods, not by expert adjudication of device outputs.

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

No. The study described is a comparison of the device's measurements against established methods and a predicate device, not a human reader study 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 standalone performance evaluations of the seca mBCA 514's ability to measure or estimate various body composition parameters compared to established reference methods and a predicate device. The device's output (measurements and estimations) is directly compared.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established using established scientific methods considered gold standards for body composition measurement:

• Deuterium oxide dilution method: For Total Body Water (TBW)
• Sodium bromide dilution method: For Extra Cellular Water (ECW)
• GE Lunar iDXA Bone Densitometer (K052581): For Lean Soft Tissue (LST)
• Four compartment model (incorporating GE Lunar iDXA, BOD POD Sonamet Body Composition Analyzer (K060848), and deuterium oxide dilution method): For Fat-Free Mass (FFM)
• Biospace InBody 720 (K052646): As a predicate device for Impedance raw data and Weight.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set size. Body composition analyzers typically use pre-developed algorithms and regression equations, which are often derived from large historical datasets, but no details are given here regarding the specific training set for seca's algorithms.

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

The document does not provide information on how the ground truth for any potential training set was established. It only describes the methods used for the comparative clinical testing to establish substantial equivalence.

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