(54 days)
The KARL STORZ OR1™ SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.
The KARL STORZ OR1™ SCB CONTROL is a central control unit which provides a single point of contact in the operating room for centralized control of various medical devices in sterile and non-sterile areas during diagnostic and therapeutic procedures. The system consists of KARL STORZ OR1™ SCB CONTROL software run on a dedicated KARL STORZ OR1™ SCB CONTROL hardware platform (Model Number: WU300) which connects to a touch-sensitive LCD monitor (Model Number: WM100 or WM101).
The user interface enables central display and control of multiple parameters for KARL STORZ and third-party devices connected via SCB serial cable or ethernet cable to the KARL STORZ OR1™ SCB CONTROL hardware CPU. The equipment controls can be operated via sterile input on the touchscreen monitor with the use of a sterile disposable cover. Outside the sterile area a keyboard or mouse can optionally be used.
The provided document is a 510(k) Summary for the KARL STORZ OR1™ SCB CONTROL. It is a control unit for medical equipment in an operating room and does not involve AI or diagnostic capability. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or MRMC studies for an AI-powered device.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (electrical safety, EMC, software lifecycle, V&V testing) and does not present acceptance criteria or detailed study results in the context of diagnostic accuracy or AI performance.
Therefore, I cannot provide the requested information based on the given document.
§ 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.