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Exofin® High Viscosity Topical Skin Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.

Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Exofin® High Viscosity Topical Skin Adhesive is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. It is provided in a single-use, aluminum, collapsible tube fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disk and soft elastomeric brush, used to apply and spread the adhesive evenly. The adhesive and applicator tip are packaged together in a polyethylene terephthalate glycol plastic blister pack and sealed with a labeled Tyvek® blister backer. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity in Exofin® High Viscosity Topical Skin Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In-vitro studies have shown that Exofin® High Viscosity Topical Skin Adhesive acts as a barrier to microbial penetration when 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.

The provided text describes a medical device, Exofin® High Viscosity Topical Skin Adhesive, and its review for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the format requested in the prompt.

Specifically, the document focuses on the regulatory submission (510(k)) and comparison to a predicate device (Exofin® High Viscosity Tissue Adhesive). It lists various performance and biocompatibility tests conducted, and states that the device "met all performance criteria," but it does not specify what those criteria are (e.g., a numerical threshold or range for wound closure strength).

Therefore, for aspects of the prompt related to specific numerical acceptance criteria, reported performance values, sample sizes, expert qualifications, adjudication methods, or MRMC studies, that information is not present in the provided text. The document concerns a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical efficacy study with defined acceptance criteria and human expert evaluation in the same manner as, for example, an AI diagnostic algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be created. The document lists the types of performance tests conducted (e.g., Wound Closure Strength, Adhesive Strength in Tension) and states that the device "met all performance criteria." However, it does not specify the actual numerical acceptance criteria or the measured performance values for these tests. For example, it doesn't say "Wound Closure Strength must be > X N/cm" and "Reported Wound Closure Strength was Y N/cm."

2. Sample size used for the test set and the data provenance

• Cannot be determined. The document mentions performance and biocompatibility testing but does not provide details on sample sizes used for these tests, nor does it specify the provenance (e.g., country of origin, retrospective/prospective) of any data beyond indicating "In-vitro studies" for microbial barrier properties.

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

• Not applicable / Cannot be determined. This type of information is typically relevant for diagnostic devices, especially those involving image interpretation by human experts. The Exofin® device is a topical skin adhesive. Its evaluation involves laboratory performance tests and biocompatibility, not expert interpretation of diagnostic data to establish a "ground truth" in the requested sense.

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

• Not applicable / Cannot be determined. Similar to point 3, adjudication methods are relevant for studies comparing expert interpretations, often in diagnostic settings. This device's testing does not involve such a process.

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

• No. An MRMC study is not mentioned. This type of study is typically for evaluating diagnostic accuracy, especially of AI/CAD systems that assist human readers. Exofin® is a therapeutic device (a skin adhesive), not a diagnostic AI.

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

• Not applicable. This question pertains to AI algorithms, which Exofin® is not.

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

• Ground truth in the context of device performance testing: For the performance tests listed (e.g., Wound Closure Strength, Adhesive Strength), the "ground truth" would be the objective measurement against established ASTM standards and internal specifications, rather than expert consensus or pathology in a clinical diagnostic sense. For biocompatibility, it's against established biological safety endpoints.
• The document implies that the device "met all performance criteria," meaning its measured performance values conformed to the pre-defined specifications/acceptance criteria for each test (e.g., ISO, ASTM standards).

8. The sample size for the training set

• Not applicable / Cannot be determined. The device is a physical medical product (a skin adhesive), not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

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