(158 days)
Indications for use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
The SE5 Arthroscopy and Small Joint Debrider Systems are electrically powered instrumentation specifically designed for intra-articular debridement. A common control console powers the SE5 Shaver Handpiece. The SE5 Arthroscopy System is intended to be used by surgeons in orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, hip and tempomandibular joint. It will be used to resect tissue and bur bone. The voice activation system is substantially equal to AESOP voice activation system. With this upgrade there are no new issues of safety and effectiveness.
The provided text is a 510(k) summary for the Stryker SE5 Arthroscopy System with HERMES OR Control Center System. This document describes a medical device, specifically a surgical instrument, and its intended use, rather than an AI/ML powered medical device.
Therefore, the information requested for acceptance criteria and study details (like sample size, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this submission as it focuses on the performance and safety of a physical surgical system with a voice control component, and not on the diagnostic or predictive capabilities of an algorithm.
The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant electrical and medical device standards (e.g., IEC 601-1, UL 2601-1, EMC Directive). The "HERMES Voice control System Functional Test Requirements" are mentioned, indicating that the voice control aspect was functionally tested, but no specifics about acceptance criteria or study results for this component are provided in the summary.
§ 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.