(142 days)
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room including cameralcamera control unit, patient information system, DYONICS POWER II Control Unit and the Werewolf Controller.
The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.
This document is a 510(k) summary for the INTELLIO Tablet Application, which primarily discusses substantial equivalence to a predicate device (K190367) based on its intended use and technological characteristics, particularly the addition of two new compatible medical devices. The document explicitly states that "Testing demonstrated that the Smith & Nephew Tablet Application has met the performance specifications and required Cybersecurity testing therefore, is substantially equivalent to the predicate device cleared in K190367." and lists "Software verification" and "Software validation" as conducted tests.
However, the provided text does not contain the specific details regarding acceptance criteria for performance, device performance metrics, sample sizes, data provenance, ground truth establishment, or multi-reader studies that you requested. It acts as a high-level summary confirming that testing was done and met specifications for substantial equivalence, but it does not elaborate on the specifics of those tests or their results.
Therefore, I cannot fulfill your request for the detailed table and study information based solely on this document. The document suggests that such performance specifications and verification/validation results exist but does not provide them within this 510(k) 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.