(132 days)
Exofin® Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® Fusion Skin Closure System has a low viscosity. In vitro studies have shown that Exofin® Fusion Skin Closure System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established. Exofin Fusion Skin Closure System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of two incisions up to 20 cm each in length until the liquid adhesive is applied to achieve skin closure.
The provided document describes the Exofin® Fusion Skin Closure System and its substantial equivalence to the predicate device, Dermabond™ Prineo™ Skin Closure System. However, it does not contain information on acceptance criteria or a study proving the device meets an algorithm's acceptance criteria.
The document outlines a 510(k) submission for a medical device (a skin closure system), not an AI/ML powered device. The "Performance Data" section details several physical and biological tests conducted on the device components, such as wound closure strength, adhesive strength, biocompatibility, and a porcine wound healing study, to demonstrate its safety and effectiveness. These tests are relevant for a physical medical device.
Therefore, I cannot fulfill the request as it pertains to AI/ML specific acceptance criteria, test set sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.
The closest information provided is:
- Type of Ground Truth Used (for the animal study): Histological analysis (for the porcine wound healing study).
- Sample size for the training set: Not applicable/not mentioned, as it's not a machine learning study.
- How the ground truth for the training set was established: Not applicable/not mentioned.
Essentially, the device in question is a physical tissue adhesive system, not an AI software.
§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
(a)
Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.