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CUTIVA™ Topical Skin Adhesive (RM1700) 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. CUTIVA™ Topical Skin Adhesive (RM1700) should be used in conjunction with, but not in place of, deep dermal stitches.

The CUTIVA™ PLUS Skin Closure System (RM1739) 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. CUTIVA™ PLUS Skin Closure System (RM1739) 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 application of the liquid adhesive.

CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) are skin closure devices that are comprised of a 2-octyl cyanoacrylate liquid adhesive formulation. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. The CUTIVA™ PLUS Skin Closure System (RM1739) also incorporates a self-adhering mesh component that is applied to the wound prior to the application of the liquid adhesive to align the skin edges. The liquid adhesive is then applied to the mesh with the adhesive applicator to complete the device application.

Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) provide a physical barrier to microbial penetration as long as the adhesive film remains intact. In vitro studies have been performed to demonstrate the microbial barrier properties of CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) for 72 hours after device application. No clinical studies have been performed and no clinical benefit associated with the in vitro microbial barrier performance of the device has been demonstrated.

The provided text is a 510(k) summary for medical devices (Topical Skin Adhesives and Skin Closure Systems), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML performance, such as sample sizes for test/training sets, expert qualifications, and human-in-the-loop studies, is not contained within this document.

The document discusses the substantial equivalence of the new devices (CUTIVA™ Topical Skin Adhesive and CUTIVA™ PLUS Skin Closure System) to legally marketed predicate devices, focusing on:

• Device Description: What the devices are made of (2-octyl cyanoacrylate liquid adhesive, with an additional mesh component for the PLUS system).
• Indications for Use: What the devices are intended for (holding closed easily approximated skin edges of wounds).
• Comparison of Technological Characteristics: A table comparing features of the new devices to predicates (e.g., sterilization method, applicator style, polymerization initiating agent).
• Performance Data: This section details bench studies (viscosity, setting time, strength tests like wound closure strength, tensile strength, lap shear strength, heat of polymerization, applicator functionality, microbial barrier), animal studies (porcine study evaluating safety and effectiveness comparably to predicate devices), and biocompatibility testing (cytotoxicity, sensitization, irritation, pyrogenicity, systemic injection, subcutaneous implantation, systemic toxicity) to demonstrate substantial equivalence.
• Sterilization and Shelf-Life: Details on the sterilization processes and shelf-life confirmation.

Therefore, I cannot provide the requested table and information as it specifically pertains to the evaluation of AI/ML device performance, which is not described in this regulatory submission for a topical skin adhesive.

The acceptance criteria mentioned in the document relate to the successful completion of various physical, chemical, and biological tests for the adhesive devices, and where applicable, demonstration of comparable performance to predicate devices. For example, "All success criteria were met for Endpoint 1 (overall animal health), Endpoint 2 (test article performance), and Endpoint 3 (local tissue response to the test article)" in the porcine study. These are not acceptance criteria for AI/ML model performance metrics.

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