(141 days)
The Huibao BE-136 Body Fat Scale measures body weight and impedance for the person standing on the four foot electrodes, and then estimates and displays the information of body weight, total body fat percentage, total body water percentage, bone mass, and daily calorie intake(DCI) using Foot-to-Foot BIA(bioelectrical impedance analysis) method. BF-136 is intended for the healthy person whose age is between 10 and 80 years old
The Huibao BF-136 Body Fat Scale is a program-controlled body composition analyzer that utilizes Foot-to-Foot BIA(bioelectrical impedance analysis) to determine body weight, total body fat percentage, total body water percentage, bone mass, and daily calorie intake(DCI) for the person whose age is between 10 and 80 years old.
The Huibao BE-136 Body Fat Scale measures body weight and impedance for the person standing on four foot electrodes which generate a 100 µA/30KHz current for the measurement of body impedance, and then estimates and displays the information of body weight, total body fra percentage, total body water percentage, bone mass, and daily calorie intake(DCI) via taking the input personnel body condition parameters into account.
This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Huibao Body Fat Scale, model BF-136, to a predicate device, the TANITA InnerScan Body Composition Monitor model BC-534 (K040778).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Huibao Body Fat Scale, model BF-136, was defined as the deviation between its measurements and those of the predicate device (TANITA/BC-534) being within 10%. The study's reported device performance met these criteria for all measured parameters.
| Comparison feature | Max. deviation | Min. deviation | Acceptance Criteria (Deviation vs. Predicate) | Verdict |
|---|---|---|---|---|
| 1. Body Fat Percentage | 9.09 % | -8.70 % | ≤ 10% | Acceptable |
| 2. Water Percentage | 8.83 % | -3.33 % | ≤ 10% | Acceptable |
| 3. Bone Mass | 9.09 % | -5.88 % | ≤ 10% | Acceptable |
| 4. Daily calorie intake | 1.18 % | -1.45 % | ≤ 10% | Acceptable |
2. Sample Size and Data Provenance
- Sample Size for the Test Set: 35 male and female subjects.
- Data Provenance: The study was "performed by manufacturer," implying an internal study, likely conducted in China based on the submitter's location. The study is retrospective in the sense that it compares the new device's readings to an existing predicate device.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth for this study was established by comparison to a predicate device, not through expert review of diagnostic images or clinical assessments.
4. Adjudication Method for the Test Set
Not applicable. There was no adjudication method described as it was a direct comparison between two devices.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This was not a MRMC comparative effectiveness study. It was a performance comparison between an investigational device and a predicate device.
6. Standalone Performance Study
A standalone performance study was performed in the sense that the device's measurements (body weight, total body fat percentage, total body water percentage, bone mass, and daily calorie intake) were directly compared to those of a predicate device. The performance focused on the agreement between the two devices.
7. Type of Ground Truth Used
The ground truth used was the measurements obtained from a legally marketed predicate device, the TANITA InnerScan Body Composition Monitor model BC-534 (K040778). The "ground truth" for the new device's performance was its agreement with this established device.
8. Sample Size for the Training Set
Not applicable. The document does not mention any training set as this type of device (body fat scale using BIA) typically relies on algorithms derived from physiological models rather than machine learning models that require specific training sets in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no explicit mention of a training set for machine learning. The device utilizes "Foot-to-Foot BIA (bioelectrical impedance analysis)" which relies on established physiological algorithms to estimate body composition parameters. The performance evaluation focused on comparing the output of these algorithms against a predicate device.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.