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The Yamato ClockMINI and ClockNAVI Body Fat Monitors are intended for use in the estimation of body fat percent in users between the ages of 10 and 80 years old.

The Yamato ClockMINI Body Fat Monitor -- DF301 (ClockMINI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to estimate body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent. In addition, the ClockMINI classifies the body fat percent into one of four categories: low, average, high, and very high.

The Yamato ClockNAVI Body Fat Monitor - DF311 (ClockNAVI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to measure body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent and a classification of obesity level. The device also calculates Body Mass Index (BMI) from data input by the user and displays an obesity level classification based on the calculated BMI.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Males: 0.1%
• Females: -0.2% |
  | Device shows minimal variability compared to the gold standard (UWW). | The standard deviation of the difference between the Yamato devices and UWW was between 3.2% and 3.3% for both males and females. The document states these numbers are "quite small" when considering the variability associated with both methods (UWW and BIA). |
  | Device is suitable for the intended user population (age 10-80). | The devices were tested against the UWW method, and the results are presented for male and female populations, supporting the stated age range by not identifying any age-related performance issues. The primary indication for use for the Yamato devices is the estimation of body fat percent in users between the ages of 10 and 80 years old, which is consistent with the predicate device. |
  | The technological characteristics of the device align with the predicate device (Omron HBF-306 Body Fat Analyzer). | The devices are equivalent in:
• Method for estimating body fat percent (BIA)
• Calculation for Body Mass Index (BMI)
• Current and Frequency specifications (50kHz/500µA)
• Route of current through the body
• Data input (height, weight, age, gender)
• Output parameters (BMI (ClockNAVI only), Body Fat%) |

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

• Sample Size: 149 subjects (51 males and 98 females).
• Data Provenance: The document does not explicitly state the country of origin. It mentions a "Yamato study," which implies it was conducted by the manufacturer or a third party on their behalf. The data is retrospective in the sense that the study was conducted and then reported for regulatory submission.

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

• This information is not applicable in the traditional sense of expert review for image-based diagnostics. The ground truth method used was an objective measurement: Under Water Weighing (UWW), which is considered a gold standard for body composition analysis. Therefore, no "experts" were used for subjective assessment; the UWW method itself provides the ground truth.

4. Adjudication Method for the Test Set

• None. Since the ground truth was an objective measurement (UWW), there was no need for expert adjudication. The comparison was directly between the device's output and the UWW measurement.

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

• No. An MRMC study was not performed. This type of study is more relevant for diagnostic devices where human readers interpret medical images or data. The Yamato devices are standalone body fat monitors, and the performance study was a direct comparison to an objective gold standard, not an assessment of human interpretation with or without AI assistance.

6. Standalone Performance Study

• Yes. The described study is a standalone performance study. It directly assessed the algorithm's performance (as embodied by the Yamato ClockMINI and ClockNAVI devices) by comparing its body fat percentage estimates against the Under Water Weighing (UWW) method, which served as the ground truth. There was no human-in-the-loop component in this particular performance assessment.

7. Type of Ground Truth Used

• Objective Measurement (Gold Standard): Under Water Weighing (UWW).

8. Sample Size for the Training Set

• Not explicitly stated/Not applicable for this type of device submission. The document describes a performance evaluation of the final device/algorithm, not the development or training of the algorithm itself. For a 510(k) submission for a device like this, the focus is typically on demonstrating substantial equivalence to a predicate device and showing that the final product performs as intended. The details of the algorithm's internal training data are not typically required for this type of submission.

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

• Not explicitly stated/Not applicable for this device submission. As mentioned above, the submission focuses on the performance of the final device. The document does not provide details on the development or training of the Bioelectrical Impedance Analysis (BIA) algorithms used in the Yamato devices, nor how any potential "training" ground truth would have been established for this internal process. The BIA method is a well-established scientific principle with algorithms developed over time, not necessarily a machine learning model that undergoes a distinct "training set" process for each new device.

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