(97 days)
Novosyn Quick Absorbable Suture is indicated for use in general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Novosyn Quick suture is not intended for use in ligation in ophthalmic, cardiovascular or neurological procedures.
Novosyn Quick is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn Quick is composed of a copolymer made from 90% gylcolide and 10% L-lactide (PGLA). The Novosyn Quick suture is coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. The Novosyn Quick suture is undyed and will be offered in diameters ranging from USP size 6-0 through 2. It will be available in a variety of cut lengths with or without needles attached.
This document is a 510(k) premarket notification for a medical device called "Novosyn Quick Absorbable Suture." It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe an AI medical device or a study involving human readers or AI assistance in diagnostic tasks.
Therefore, I cannot extract information related to acceptance criteria and study designs for an AI medical device, as requested in the prompt. The information provided is purely for a traditional surgical suture and its physical and biological performance characteristics.
Specifically, the document does not contain any of the following information relevant to your request:
- Acceptance Criteria for an AI device: The document lists acceptance criteria for a physical medical device (suture) based on USP requirements and biocompatibility, not for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
- Study that proves the device meets acceptance criteria for AI: The "performance data" section details mechanical testing (diameter, tensile strength, needle attachment) and biocompatibility testing for the suture, which are physical and biological tests, not clinical performance studies for an AI algorithm.
- Sample size for test set and data provenance for AI: No such data exists in the document.
- Number of experts and their qualifications for AI ground truth: Not applicable.
- Adjudication method for AI test set: Not applicable.
- MRMC comparative effectiveness study: Not conducted.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used for AI: Not applicable.
- Sample size for training set for AI: Not applicable.
- How ground truth for training set was established for AI: Not applicable.
In summary, this document is entirely about a surgical suture and does not contain the information needed to answer your request about an AI medical device.
§ 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.