(62 days)
Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and dissect tissue and sutures during all flexible endoscopic procedures.
The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection and the cutting of sutures during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue and suture materials during all flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and study proving device performance as it relates to AI/ML devices. The document describes a 510(k) submission for "Ensizor Endoscopic Scissors," which are mechanical, non-AI medical devices.
Therefore, I cannot extract:
- A table of acceptance criteria and reported device performance related to an AI/ML device.
- Sample size used for the test set or data provenance for an AI/ML study.
- Number of experts or their qualifications for establishing ground truth in an AI/ML context.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results (effect size of human readers with/without AI assistance).
- Standalone (algorithm-only) performance results.
- Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
- Sample size for the training set of an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
The document discusses non-clinical performance data for the endoscopic scissors, including:
- Operation in Tortuosity: Ensuring the device can open and close when the distal shaft is formed into a 20 cm diameter circle.
- Sample Cutting: Cutting various suture and polyethylene materials at least 10 times.
- Comparative Testing to US Endoscopy Suture Cutter: Functional testing in straight and tortuous pathways, and simulation testing to grasp and cut various sutures.
The table provided in the document summarizes acceptance criteria and performance for these mechanical tests, not AI/ML performance.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.