(111 days)
The Omron HBF-500 body composition monitor with scale is intended to be used to calculate and display the estimated value of body fat percentage, skeletal muscle percentage, resting metabolism, BMI and visceral fat levels using the BI (Bioelectrical Impedance) Method and indicates the BMI (Body Mass Index).
The Omron HBF-500 is intended to be used by healthy individuals in the age range of 18 to 80 years for the skeletal muscle percentage, resting metabolism and visceral fat level. The age range for body fat percentage is intended to be used by healthy individuals between the age of 10 to 80 years.
Body Composition Monitor and Scale Model HBF-500
The provided text is a 510(k) summary from the FDA for a Body Composition Monitor and Scale. It outlines the regulatory approval for the OMRON Body Composition Monitor and Scale Model HBF-500. However, the document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
The document states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."
This indicates that a comparison to a predicate device was performed to demonstrate substantial equivalence, but the specific acceptance criteria and performance data from internal studies that supported this claim are not present in this particular FDA letter. Such detailed study information would typically be found in the manufacturer's 510(k) submission itself, which is not fully included here.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies 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.