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CM005 Standard Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff.

CM004 Mini Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.

CM005 Standard Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided as a single-use applicator in a blister package. The pen style applicator is composed of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.

CM004 Mini Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2 It is provided in a singleuse applicator packaged in a blister pack. The applicator is comprised of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.

This document is a 510(k) summary for medical devices (CM005 Standard and CM004 Mini Topical Skin Adhesives) and as such does not contain a study addressing acceptance criteria in the manner requested (i.e., with statistical performance metrics against a defined ground truth, typical for AI-software devices).

The provided text describes performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study with acceptance criteria against a clinical outcome or expert ground truth for an AI/software device. The devices are topical skin adhesives, not AI/software devices. Therefore, a table of acceptance criteria vs. device performance, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or methods for establishing ground truth for training data are not applicable in the context of this document.

The "acceptance criteria" for these devices are demonstrated through a series of performance tests and biocompatibility assessments, showing that they are substantially equivalent to already cleared predicate devices.

Here's a summary of the type of performance criteria and tests carried out (as described in the document), rather than a direct answer to the prompt's table due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

Since this is not an AI/software device, there aren't explicit numeric "acceptance criteria" in the traditional sense of diagnostic accuracy (e.g., sensitivity, specificity). Instead, substantial equivalence is demonstrated by performing various tests to show that the new devices perform comparably to predicate devices. The document states:

"It was determined through the testing (Bench and Animal) performed in this 510(k) submission, that the subject devices are substantially equivalent to the predicate devices and any minor differences in performance does not affect safety or efficacy."

The specific performance tests conducted were:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for each individual test or their provenance. The tests were bench and animal studies (laboratory and pre-clinical, respectively).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to a non-AI/software device submission. Ground truth for these physical and biochemical tests is established by standardized testing protocols (e.g., ASTM standards) and animal study observations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a non-AI/software device. The tests follow established protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests, the "ground truth" is defined by the accepted results or outcomes of standardized physical, chemical, and biological tests (e.g., tensile strength measurements, viscosity values, lack of cytotoxicity as per ISO 10993-1). For the animal wound healing study, the ground truth would be histological assessment and observation of wound closure and healing characteristics.

8. The sample size for the training set

Not applicable, as this is not an AI/software device.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/software device.

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The Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple thoroughly cleansed, trauma- induced lacerations. The 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.

CM00622 Skin Wound Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampoule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that following polymerization, CM00622 LINC acts as a physical barrier (for up to 7 days) to microbial penetration as long as the polymerized liquid topical skin 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.

CM00622 LINC also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liguid topical skin adhesive is applied to achieve skin closure.

The provided text is a 510(k) Summary for the CM00622 LINC Skin Closure System. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study describing the device performance against specific acceptance criteria in a clinical or standalone setting as would be applicable to AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in this document.

However, I can extract information related to performance testing conducted to support the claim of substantial equivalence.

Here's a summary based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document states that "Testing was performed in accordance with the FDA special controls guidance document for 'Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin' Issued on: November 10, 2010" and that "Performance testing found that the subject device is substantially equivalent to the predicate device and these differences do not affect safety or efficacy."

While specific numerical acceptance criteria and reported performance values are not provided in this summary, the general acceptance criterion is substantial equivalence to the predicate device (DERMABOND™ PRINEO™ Skin Closure System) based on various performance tests. The reported performance is that the device met this criterion, indicating that results from the tests were comparable to the predicate within acceptable limits.

2. Sample sized used for the test set and the data provenance:

This information is not provided in the document. The performance tests listed are bench and animal studies (pre-clinical), not clinical studies with a human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as this is not a study assessing diagnostic performance against a ground truth established by experts. The performance tests are largely objective physical and biological tests.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a medical product (skin closure system), not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical product, not an algorithm.

7. The type of ground truth used:

For the performance tests, the "ground truth" (or reference standard) would be the established methods and expected performance characteristics for such devices, as outlined in the FDA guidance and industry standards (e.g., ASTM standards). For the animal study, the ground truth would be observed wound healing outcomes compared to a control or predicate.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of what was included:

The document lists the following performance tests conducted to demonstrate substantial equivalence:

• Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04)
• Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06)
• Tensile Properties of Thin Plastic Sheeting (ASTM D882-12)
• Lap-shear strength (ASTM F2255-05)
• T-peel adhesion strength(ASTM F2256-05)
• Adhesive strength in tension (ASTM F2258-05)
• Wound closure strength(ASTM F2458-05)
• Adhesive degradation study
• Heat of polymerization
• Viscosity
• Dry time
• Microbial barrier testing (Note: Clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between these properties and infection reduction has not been established.)
• Device Yield and Quality of Film
• Flow Control
• Animal wound healing study

Biocompatibility tests:

• Physical and/or chemical information: Solvent compatibility, Chemical characterization and Toxicological risk assessment.
• Cytotoxicity.
• Sensitization.
• Intracutaneous reactivity.
• Material mediated pyrogenicity.
• Endotoxin mediated pyrogenicity.
• Acute systemic toxicity.
• Implantation (including sub-acute toxicity).

The conclusion states that based on these tests, the CM00622 LINC Skin Closure System has been demonstrated to be substantially equivalent to the predicate device.

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