(18 days)
The VENDYS Model 6000 Model B/BC is a non-invasive digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands). It is intended to use for measurement of vascular reactivity by monitoring temperature changes before, during, and after a reactive hyperemia test using a 2-5 minute cuff occlusion procedure.
The VENDYS Model 6000 Model B/BC is a non-invasive digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands).
The provided document is a 510(k) clearance letter from the FDA for the VENDYS Model 6000 B B/C device. It does not contain specific information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
The letter acknowledges the substantial equivalence of the device to a legally marketed predicate device but does not detail the technical performance data or the studies conducted to demonstrate that performance. Therefore, I cannot provide a table of acceptance criteria and reported device performance or other specific study details based on this document.
To answer your request, I would need access to the actual 510(k) submission, which would include the performance data and study reports.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).