(347 days)
The Rowenta Bodypartner VISION/SCALE is intended to measure weight and body impedance which are used to calculate an estimated value for fat mass and lean mass.
Not Found
This document is a 510(k) premarket notification letter from the FDA for a device called the "BODYPARTNER VISION Model BM 210." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. It outlines general controls and regulations applicable to the device. The indications for use are also described, stating the device "is intended to measure weight and body impedance which are used to calculate an estimated value for fat mass and lean mass."
Therefore, I cannot provide the requested information from this document. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.