(63 days)
The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "VES 3001-M Complete Video Endoscopic System". This letter primarily addresses the regulatory clearance of the device and does not contain detailed information about acceptance criteria or performance studies as typically requested for AI/ML-driven devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but does not provide specific performance metrics or the studies that would demonstrate them.
§ 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.