(179 days)
GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.
Survisorb brand absorbable suture is provided both dyed (D&C Viclet #2) and undyed (milk white), braided and monofiliment types and coated with polyceprolate and calcium sterate. Sizes offered are U.S.P. 8.0 through 2 (mstric equivalcht 0.4 through 5). Michaels. Polyglycolic acid. U.S.P. & polycaprolate and calcium sterate.
The provided text is a Premarket Notification (510(k)) for the "Surgisorb" absorbable suture, indicating it is substantially equivalent to a predicate device. This type of document does not typically contain acceptance criteria or detailed study results in the manner requested for AI/device performance.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Dexon® II polyglycolic acid, synthetic absorbable surgical sutures) based on material, packaging, sterilization, sizes, and functional characteristics (absorption rate, strength, etc.), as well as meeting or exceeding USP 23 performance requirements.
Therefore, I cannot provide the specific information requested in the format of a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or details of standalone or MRMC comparative effectiveness studies, as these types of studies and their detailed results are not typically included in a 510(k) submission summary for this class of medical device.
Here's what can be extracted and inferred from the document:
-
Acceptance Criteria & Reported Device Performance:
- Acceptance Criteria (Implied): The device must meet or exceed the performance requirements of USP 23 (United States Pharmacopeia) for absorbable surgical sutures. It also must be substantially equivalent to the Dexon® II polyglycolic acid suture in terms of materials, packaging, sterilization method, sizes, multi and monofilament types, dyed and undyed states, and functional characteristics (absorption rate, strength).
- Reported Device Performance: The document explicitly states: "Surgisorb and Dexon® II both meet or exceed the performance requirements of USP 23." This implicitly states that Surgisorb also meets these criteria. The "Summary Comparison Table" (page 2) lists features where Surgisorb is "SAME" as the predicate device, implying comparable performance.
-
Sample Size and Data Provenance: Not specified in this 510(k) summary. These details would be in the underlying testing documentation, not the public summary.
-
Number of Experts and Qualifications: Not specified. The determination of "substantial equivalence" is made by the FDA based on the manufacturer's submission. The performance testing against USP standards would be conducted in laboratories, but the specific expert involvement for establishing "ground truth" as might be relevant for AI models is not applicable here.
-
Adjudication Method: Not applicable for this type of device submission.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is not an AI-assisted diagnostic tool.
-
Stand-alone Performance (Algorithm Only): Not applicable, as this is a physical medical device (suture), not an algorithm.
-
Type of Ground Truth Used: The "ground truth" here is compliance with established industry standards (USP 23) and demonstrated equivalence to a predicate device through material and functional characteristic comparisons. This is based on USP standards and direct material/performance testing, not expert consensus, pathology, or outcomes data in the AI sense.
-
Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
-
How Ground Truth for Training Set was Established: Not applicable. This is not an AI/machine learning device.
In summary, the provided document is a 510(k) Pre-market Notification for a surgical suture and does not contain the detailed study information (especially related to AI/algorithm performance) that your template requests.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.