(101 days)
This device is indicated for use in conjunction with an endoscope in the gastrointestinal tract for tissue or foreign body manipulation and/or where multiple removal and insertions of an endoscope are required.
The ORISE Tissue Retractor System is comprised of the ORISE Tissue Retractor (OTR) consisting of the handle, the flexible shaft with expandable distal end (chamber) and the associated instrument guides called the ORISE Instrument Guides (OIGs) which are flexible conduits, guiding other instruments such as graspers. The OIG is available in three (3) tip configurations; with 45°, 60° and 90° tip bend angles. Shaft Markers are used for reference purposes for aid in placing the retractor.
The provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of an AI/ML-based medical device.
The document is a 510(k) premarket notification for the ORISE™ Tissue Retractor System, which is a physical medical device (an endoscope accessory), not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.
The document discusses:
- Acceptance Criteria for the ORISE™ Tissue Retractor System: This is inferred from the "Performance Data" section (Section 7). The device underwent "Functional and performance tests" to demonstrate "substantial equivalence" and satisfy "design verification requirements." It "passed all tests." Specific tests mentioned include "OTR and OIG dimensional testing, OTR and OIG performance testing including simulated use testing, Tensile strength testing, OTR scope compatibility, OIG instrument compatibility and OTR/OIG compatibility." Biocompatibility testing was also performed and passed.
- Study Proving Acceptance: The "Bench Testing" and "Biocompatibility Testing" sections describe the studies. These are laboratory-based tests rather than clinical studies with human participants for performance evaluation in the way an AI/ML device would be evaluated.
To directly answer your questions based only on the provided text, many fields would be "Not Applicable" or "Information Not Provided" as they pertain to AI/ML device evaluation, not a physical medical device like the ORISE™ Tissue Retractor System.
§ 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.