(10 days)
Maxon** and Maxon CV** sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.
Maxon** and Maxon CV** monofilament synthetic absorbable sutures (clear or green) are prepared from a copolymer of glycolic acid and trimethylene carbonate. The sutures are sterile, inert, noncollagenous and nonantigenic.
The provided text is a 510(k) summary for a surgical suture and does not contain information about acceptance criteria or specific study results that would typically be reported for a device meeting acceptance criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe acceptance criteria and associated study results. The document does not provide the following information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document primarily serves to:
- Identify the device (Maxon Synthetic, Absorbable Surgical Suture).
- State its intended use.
- Establish substantial equivalence to predicate devices for regulatory clearance.
- Outline regulatory classifications and requirements for its marketing.
§ 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.