(159 days)
The ElectroFluidGraph™is used to estimate the subject's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water; in "generally healthy" subjects of 21 to 87 years old.
Not Found
The provided FDA 510(k) document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
This document is a letter from the FDA granting substantial equivalence for the ElectroFluidGraph™ device, meaning it's deemed equivalent to a predicate device already on the market without requiring new clinical trials to prove safety and efficacy. The letter primarily focuses on regulatory compliance, outlining the requirements for marketing the device.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance: This information is not present in the document.
- Sample size used for the test set and data provenance: No test set or data provenance is detailed.
- Number of experts used to establish ground truth and their qualifications: No ground truth establishment is described.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study or effect size: No human reader study is discussed.
- Standalone performance study: No standalone algorithm performance is described.
- Type of ground truth used: Not applicable as no ground truth is discussed.
- Sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document states the device "is used to estimate the subject's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water; in 'generally healthy' subjects of 21 to 87 years old." However, it does not provide any performance metrics (e.g., accuracy, precision, correlation with a gold standard) to demonstrate how well it performs these estimations.
§ 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.