(210 days)
MEASUREMENT OF ESTIMATED EXTRA-CELLULAR WATER; ESTIMATED INTRA-CELLULAR WATER. ESTIMATED TOTAL BODY WATER; AND
Not Found
I apologize, but the provided text does not contain the information needed to describe acceptance criteria, device performance, or details about a study. The document is an FDA 510(k) clearance letter for a device called "BodyStat® MultiScan 5000" and an "Indications For Use" statement.
It primarily states that the device is substantially equivalent to a pre-amendment device and outlines regulatory general controls and responsibilities. There is no information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for training data.
Therefore, I cannot fulfill your request for this specific information based on the provided text.
§ 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.