(75 days)
The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.
The Edwards Suture Fastening System is comprised of the fastening instrument and the fastener loader. These components interface together to deploy a nitinol fastener onto a suture and then cut the suture 5 mm proximal to the nitinol fastening instrument has a 3 mm (0.1 inches) diameter shaft which is available in three lengths: 15 cm (5.9 inches), 22 cm (8.7 inches) and 30 cm (11.8 inches). A handle and a trigger are located at the proximal end of the instrument. By activating the trigger, the fastening instrument deploys the nitinol fastener at the intended position and cuts the suture. Each fastener loader holds one nitinol fastener which is pre-loaded in the locking tip.
The provided document is a 510(k) summary for the Edwards Suture Fastening System. It details nonclinical performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the format of an AI model's performance.
The document describes tests for a physical medical device (a suture fastening system), not an AI algorithm. Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to the content of this regulatory submission for a manual surgical instrument.
The document lists various nonclinical tests and states that "all results met acceptance criteria," but it does not quantify or specify those acceptance criteria for most tests, nor does it provide detailed performance reports for each criterion in a table format suitable for an AI model.
Therefore, I cannot fulfill the request as specified because the input document does not pertain to the evaluation of an AI-powered device or algorithm.
If you are looking for an example of how such a table and study description would be presented for an AI device, please provide a document that describes the evaluation of an AI algorithm.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.