(178 days)
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed for grasping tissue and/or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
This 510(k) summary (K962474) describes a medical device, the Olympus FG Grasping Forceps, intended for grasping and retrieving tissue and foreign bodies during endoscopic procedures. It is a premarket notification for a new version of an existing device and does not contain any information about acceptance criteria, device performance studies, or AI/software validation.
Therefore, I cannot provide the requested information in the format given. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing performance evaluation data typically found for diagnostic AI devices.
Here's why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria or Performance Data: The 510(k) summary does not mention any specific performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or acceptance criteria for those metrics. It only describes the intended use and physical characteristics of the device.
- No AI/Software Component: The device is a physical grasping forceps, not an AI or software-driven diagnostic or therapeutic tool. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," "stand-alone performance," or "human reader improvement with AI" are not applicable.
- No Study Described: The document is a regulatory submission summary, not a study report. It states that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar, but it does not present new study data to prove this equivalence in terms of specific performance metrics.
In summary, the provided document is not relevant to the questions posed, as it describes a mechanical medical device and lacks any data or discussion regarding performance acceptance criteria or a study demonstrating such performance, especially concerning AI or software validation.
§ 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.