(69 days)
The Polypropylene nonabsorbable surgical sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Polypropylene nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to Surgilene™ polypropylene nonabsorbable surgical sutures manufactured by Davis+Geck.
The Polypropylene sutures manufactured by R. K. Medical and D+G are monofilament and are dyed blue [ phthalocyaninato (2--) | copper .
The provided text is a 510(k) summary for R. K. Medical's Polypropylene Nonabsorbable Surgical Sutures. This document aims to demonstrate the substantial equivalence of their sutures to an existing predicate device (Surgilene™ polypropylene nonabsorbable surgical sutures by Davis+Geck).
However, the information provided does not contain a description of an AI-powered device or a study involving AI. All the details pertain to a traditional medical device (surgical sutures) and its comparison to a predicate device based on physical characteristics and performance in accordance with USP standards.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves an AI device meets those criteria, nor can I provide information about sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document.
The document discusses:
- Acceptance Criteria (implied): Meeting or exceeding USP XXIII specifications for suture diameter, suture length, knot pull tensile strength, and needle attachment strength.
- Device Performance: The R. K. Medical polypropylene sutures "meet or exceed U.S.P. specifications and are equivalent in terms of the above parameters to polypropylene sutures manufactured by Davis+Geck."
- Study: The "Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength according to methods outlined in USP XXIII."
But, as stated, this is for a physical medical device, not an AI device.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.