(29 days)
The OverStitch Sx Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
OverStitch™ Sx Endoscopic Suturing System and The accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.
The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using thermoplastic polyurethane straps for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.
The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.
The provided text is a 510(k) summary for the Apollo Endosurgery OverStitch™ Sx Endoscopic Suturing System. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, or information about human expert involvement or MRMC studies for AI performance. The document explicitly states "Clinical testing was not required to demonstrate substantial equivalence."
Therefore, I cannot provide a table of acceptance criteria, detailed study results proving acceptance, or information about AI-related aspects (sample sizes, ground truth, experts, MRMC, standalone AI performance) based on the provided text.
The closest information available regarding "acceptance criteria" is a general statement about non-clinical performance data:
"Acceptance criteria were met in each of the studies listed above. The results confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised."
The studies mentioned are:
- Non-Clinical Performance Data:
- Bench testing: suture drag testing, tensile testing, endoscope compatibility, reliability, and bond strength.
- Functional Testing: an ex vivo model utilized under the same test methods as the predicate.
- Packaging Integrity: testing in accordance with ASTM F2096-11, ASTM F1980-16, ASTM D4169-16 and ASTM F88/F88M-15.
- Biocompatibility: Testing and toxicological assessments performed in accordance with ISO 10933-1, including cytotoxicity, irritation and skin sensitization, systemic toxicity, and material mediated pyrogenicity.
Without specific numerical values or targets for these tests, a table of acceptance criteria and reported performance cannot be generated. Moreover, the device described is a physical medical device (suturing system), not an AI/ML powered device, which explains the absence of information related to AI models, ground truth, expert reviews, and MRMC studies.
§ 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.