(147 days)
A body composition analyzer and a software package that will estimate display and store the following body composition parameters:
Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICVV), I Fut noo Mass (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). Extra octualiar vialer (2 x 77), voltage and phase angle (Phi), and from these values calculates The device moductions our only ready which are used to estimate the above body resistance (1), roustanto (1), roustanto (1), also display the user's height, weight, age, % oompoolion parameter of measurement, Practitioner's name and Device serial number.
This device is intended for use on healthy children (9 - 16 years old), general and obese adult rubjects, only for body composition assessment in the home or clinical environment.
The Imp DF50 is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water, intracellular water, and extracellular water.
The ImpediMed Imp DF50 Body Composition Analyzer is a battery powered, accurate, handheld, single frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.
Bioelectrical impedance analysis measures the impedance or opposition to the flow of an electric current through the body fluids contained mainly in the lean and fat tissue. Impedance is low in lean tissue, where intracellular fluid and electrolytes are primarily contained, but high in fat tissue. Impedance is thus related to total body water volume. In practice, a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed frequency of 50 kHz± 100Hz is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes provides a measure of impedance. The performance of the device may be checked with the aid of a calibration circuit (supplied as an accessory) for quality assurance or servicing purposes.
Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration for lean tissue. Fat mass is subsequently calculated as the difference between body weight and lean body mass.
The provided text does not contain detailed information about specific acceptance criteria or a study proving that the ImpediMed Imp DF50 Body Composition Analysis device meets these criteria. The document is primarily a 510(k) summary for regulatory submission, focusing on device identification, intended use, technological characteristics, and substantial equivalence to predicate devices. It does not include performance data, study designs, sample sizes, or ground truth establishment relevant to acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. The document mentions that the device "accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance," and that "Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW." However, it does not detail the specific studies, their methodologies, or the performance metrics achieved against predefined acceptance criteria.
§ 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.