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SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. The SURGISEAL Twist applicator contains the identical adhesive formula as the predicate devices, SURGISEAL® Topical Skin Adhesive and SURGISEAL StylusTM Topical Skin Adhesive, but is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip. This Twist applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin with either Applicator, it polymerizes in minutes. In vitro studies have shown that SURGISEAL acts as a physical 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.

The provided document is a 510(k) summary for a medical device called SURGISEAL Twist™ Topical Skin Adhesive. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical characteristics and bench testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics from a study aimed at proving efficacy. Instead, it describes general claims based on "extensive bench performance testing" and focuses on substantial equivalence to predicate devices. The primary purpose of this 510(k) submission is a "Labeling Change to include Microbial Barrier description," which is based on in vitro studies.

However, from the "Performance Testing" section, we can infer some criteria related to the physical properties of the adhesive application:

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "in vitro studies" and "bench tests" for performance testing.

• Sample Size for Test Set: Not explicitly stated. The phrase "Film Thickness determinations for each of the SURGISEAL Teardrop, Stylus and Twist applicators" suggests multiple samples were tested for each applicator type, but the exact number is not provided.
• Data Provenance: The tests are "in vitro" (laboratory-based) and "bench tests," meaning they were conducted in a controlled lab environment. The document is silent on the country of origin of the data beyond the submitter's address in Wyomissing, Pennsylvania, USA. The studies are retrospective in the sense that they are presented as part of a 510(k) submission which often relies on pre-market testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. For in vitro and bench tests, "ground truth" often refers to a defined standard or measurement method, rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to bench or in vitro performance testing where results are typically data-driven rather than subject to expert interpretation and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "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." This indicates that human-in-the-loop assessments or clinical outcome studies involving human readers/evaluators were not part of this submission's evidence for the labeling change.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical product (topical skin adhesive), not an algorithm or AI. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance described is inherent to the physical properties and application of the adhesive.

7. The Type of Ground Truth Used

For the microbial barrier claim, the ground truth was established through in vitro studies demonstrating the physical barrier property. For film thickness and adhesive deployment, the ground truth would be based on physical measurements and technical specifications (e.g., thickness gauges, visual inspection, or other analytical methods). It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is not an AI/ML algorithm.

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