(75 days)
The device is a non-invasive bio-impedance analyzer with scale for use in estimating human's body fat percentage by calculation using the individual's BMI (body mass index) and determination of body weight. The OMRON HBF-400 is intended to be used by healthy individuals between the age of 10 to 80 years.
The device is a non-invasive bio-impedance analyzer with scale.
This FDA Premarket Notification (510(k)) letter for the OMRON Model HBF-400 Fat Loss Monitor and Scale does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document primarily focuses on the FDA's "substantial equivalence" determination, indicating that the device is similar enough to previously approved devices to be marketed. It states the indications for use of the device but does not provide details about a specific study testing its performance against defined acceptance criteria.
To answer your request, the following information would typically be found in a separate study report or a more detailed section of the 510(k) submission, which is not provided in this document:
- A table of acceptance criteria and the reported device performance: This would include specific metrics (e.g., accuracy, precision) and the thresholds the device needed to meet.
- Sample size used for the test set and the data provenance: Details on how many participants were in the test, their demographics, and whether the data was collected prospectively or retrospectively.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information on who determined the reference standard and their expertise.
- Adjudication method for the test set: How disagreements in ground truth determination were resolved.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This usually applies to devices that assist human interpretation, which might not be directly relevant for a standalone measurement device like this body fat monitor.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This would be expected for a device like the OMRON HBF-400.
- The type of ground truth used: For a body fat monitor, this would ideally be a gold standard method like DEXA (Dual-energy X-ray absorptiometry), hydrostatic weighing, or a similar highly accurate body composition assessment.
- The sample size for the training set: (If a machine learning model was involved)
- How the ground truth for the training set was established: (If a machine learning model was involved)
Based on the provided document, I cannot fulfill your request for the specific acceptance criteria and study details. The 510(k) letter confirms the device's regulatory approval for marketing based on its substantial equivalence to a predicate device, but it does not elaborate on the specific performance studies and their results.
§ 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.