(212 days)
The BCM is used as body fat analyzer that estimate the percent body fat (%BF), percent lean body mass(%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The SAM or Stayhealthy Activity Monitor [ a triaxial accelerometer and 3axis, gyroscope equipped calorie tracker- (CT2)], is a device that is sold as companion device with the BCM and is used to track the number of calories used by the client. The device is intended for use by healthy subjects ages 8-92.
Not Found
The provided text is a 510(k) premarket notification letter for the Stayhealthy Body Composition Monitor-BCM. It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance reports, study designs, sample sizes, expert qualifications, ground truth establishment, or any of the specific details requested in your prompt (points 1-9). The letter is primarily an FDA clearance notification, not a technical report detailing the device's validation.
Therefore, I cannot provide the requested information from this document.
§ 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.