(30 days)
This instrument has been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
The subject device consists of the papillotomy knife for endoscopic sphincterotomy. The subject device consists of a partially open guidewire lumen. The partially open guidewire lumen is called the C-Channel design. The subject device is a variation of the predicate device.
The provided document is a 510(k) Summary for a medical device called "Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215". This document describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory approval.
However, the provided text does not contain the acceptance criteria or a study that proves a device meets specific performance criteria related to an AI/ML algorithm or diagnostic accuracy testing as requested in the prompt. The document is a regulatory submission for a physical medical instrument (a sphincterotome) used in endoscopic procedures, not a software-as-a-medical-device (SaMD) or a device that directly generates or interprets data for diagnostic purposes requiring performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study proving device performance in the context of AI/ML or diagnostic accuracy.
The document mentions "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment," but it does not provide the specific acceptance criteria or the results of these design verification tests. It also mentions a "Shelf-life of three years have been confirmed by accelerated aging test in accordance with ASTM F-1980-07," but no specific acceptance criteria for shelf-life performance are detailed, nor are the full results of this test provided.
In summary, the document discusses the regulatory approval process for a physical medical device and its non-clinical testing for safety and shelf-life, but not for diagnostic or AI/ML performance.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).