(74 days)
The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.
Not Found
This document is a 510(k) clearance letter from the FDA for the Angiolaz VES-1Cam device, dated August 4, 1998. It primarily confirms the device's substantial equivalence to a legally marketed predicate device and grants permission to market it.
Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter focuses on regulatory approval and states the device's intended use: "The VES-1CAM use is indicated whenever there is a need for the use of video in endoscopic procedure."
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them from the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.