(58 days)
The device is a noninvasive bioimpedance meter used to estimate body fat percentage in the home setting. The device is for normal, healthy people only, and the applicable age range is 10 to 80 years old.
The device is to be used in a home environment having normal temperature and humidity conditions.
HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
Here's a breakdown of the acceptance criteria and study information for the HEALTH & LIFE HL 188 & HL 189 BODY FAT METER, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it indicates the device's performance was validated through a comparison study and conformity to standards.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Safety & EMC | Conformity to applicable standards. | The device conforms to applicable standards including IEC 60601-1 and IEC 60601-1-2 requirements. |
| Clinical Repeatability | Statistically and clinically acceptable repeatability across groups. | "The comparison study demonstrated that the clinical repeatability of HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is statistically and clinically acceptable in all age/weight/height groups." |
| Equivalence to Predicates | No new questions of safety or effectiveness compared to predicates. | "Bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the HEALTH & HL 188 & HL 189 BODY FAT METER is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states, "Subjects were grouped as male/female, ages." It does not provide a specific number for the sample size.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be clinical. It does not specify if it was retrospective or prospective, but clinical comparison studies are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The ground truth was established by comparing to DEXA technology, but details on human experts involved are absent.
4. Adjudication Method for the Test Set
This information is not provided in the text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The study described is a comparison with DEXA technology to validate the device's performance, not a human reader study with or without AI assistance.
- Effect Size: Not applicable, as an MRMC study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the described "comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology" is essentially a standalone performance evaluation of the HL 188 & HL 189 Body Fat Meter against a reference standard. The text focuses on the device's direct measurement capabilities.
7. The Type of Ground Truth Used
The ground truth was established using DEXA (Dual energy X-ray absorptiometry) technology. DEXA is considered a highly accurate and reliable method for body composition analysis, often used as a reference standard.
8. The Sample Size for the Training Set
This information is not provided in the text. The device is a "Body Fat Meter" which implies it's a measuring device rather than an AI/ML algorithm that requires a separate training set. The comparison study described is for validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a separate training set for an AI/ML algorithm is not described for this type of device. The device directly measures bioimpedance to estimate body fat percentage. The validation study used DEXA as the ground truth for performance comparison.
§ 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.