(90 days)
The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation.
The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation. The Suture Clinch is manufactured from implant grade titanium. Its unique shape provides an optimum means of capturing and securing the suture. The unique shape of the Suture Clinch also allows the applicator (clip applier) to close the Suture Clinch completely around the suture. The Surure Clinch is available preloaded in a cartridge. The Suture Clinch Cartridge is designed to easily snap fit into the barrel of the applicator for application and quickly detach from the barrel after the clinch is applied to the suture. The single use Suture Clinch Cartridge is supplied sterile, packaged individually in a tyvek pouch.
The provided document is a 510(k) summary for the Suture Clinch device, which is a regulatory submission to the FDA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, as required for certain medical devices. This typically involves comparing specifications, materials, and intended use, rather than presenting a performance study with detailed acceptance criteria and results as would be found in a clinical or performance validation report.
Therefore, I cannot provide the requested information from the given text.
To explicitly address your request based on the provided input, I must state:
- A table of acceptance criteria and the reported device performance: Not found in the document.
- Sample sized used for the test set and the data provenance: Not found in the document, as no specific performance study is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not found, as no ground truth establishment for a test set is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not found.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device (Suture Clinch) is a physical implantable clip, not an AI software/diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical implantable clip.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not found.
- The sample size for the training set: Not applicable/Not found, as no machine learning model or training set is mentioned.
- How the ground truth for the training set was established: Not applicable/Not found.
§ 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.