(317 days)
The Stryker Sidne™ System is indicated for use with compatible endoscopic and general surgery devices. The Stryker Sidne™ System can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope fendoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectorny, laparoscopic hemia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder anthroscopy, small joint anthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The Stryker Sidne™ System is a medical device that is designed to allow the surgeon to control the state, selection, and settings of the surgical equipment it Is networked with. Sidne™ is compatible with existing devices that are HERMES OR Control Center compatible. The intent of the Sidne™ Control Center is to allow for voice control of medical device settings by the surgeon or operating room personnel, thereby eliminating the need for manual operation of those devices compatible with Sidne™ , or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called the "Sidne™ System" (formerly "Merdoc™ System"). This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance.
It does not contain the specific information requested regarding:
- Acceptance criteria and reported device performance in a table.
- Details of a study proving the device meets acceptance criteria.
- Sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information.
The document discusses the device's indications for use, its function as a control system for surgical equipment, and its conformity to voluntary standards. However, it does not provide details about clinical studies or performance metrics often associated with AI/ML device evaluations.
Therefore, I cannot fulfill your request for a table of acceptance criteria and study details based on the provided text.
§ 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.