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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. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus and Twist applicators contain the identical adhesive formula and incorporate a plastic ampoule, which houses the adhesive, contained within the double longer plastic sleeves with an attached applicator tip. When SURGISEAL is applied to the skin with these applicators, it polymerizes in minutes.

The provided document is a 510(k) premarket notification for topical skin adhesives (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or performance study.

Therefore, the information required to populate most of the sections of your request (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document. This document is related to a medical device approval and not a software or AI algorithm approval.

However, I can provide information on acceptance criteria that are implicitly or explicitly mentioned for the biocompatibility and sterilization aspects of the device, which are part of its overall safety and effectiveness.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not provided in the document):

2. Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm evaluation; for biocompatibility, sample sizes for in vitro or in vivo tests are part of the ISO standards but not detailed here. The studies were previously conducted on predicate devices. Data provenance would be related to the lab conducting the biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biocompatibility and sterilization is based on established scientific methods and standards.
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, as this is not an AI/ML 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/ML device.
7. The type of ground truth used:
   • For Biocompatibility: The "ground truth" is defined by the biological response of cells/tissues to the material, as assessed by standardized tests (e.g., cytotoxicity, irritation, sensitization assays) according to ISO-10993.
   • For Sterilization: The "ground truth" is the sterility assurance level (SAL) achieved, verified by validated sterilization cycles and appropriate microbiological testing, according to ISO 11137 and ISO 11135.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The document describes a 510(k) submission for new topical skin adhesive products (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). The "study" or rather, the evidence presented to ensure safety and effectiveness and demonstrate substantial equivalence, relies primarily on:

• Identity of Technological Characteristics: The device's formulation (monomeric 2-octyl cyanoacrylate) and mode of action are identical to previously cleared predicate devices.
• Biocompatibility Testing: Prior biocompatibility testing conducted on the predicate devices (SURGISEAL Teardrop (K082993), SURGISEAL Stylus (K130474), and SURGISEAL Twist (K130474)) in accordance with ISO-10993 was leveraged. This testing confirmed the materials were non-toxic, non-irritating, non-sensitizing, and biocompatible. No new biocompatibility testing was required because the subject devices are identical to the predicates in terms of materials.
• Sterilization Validation: Validation of sterilization methods (electron beam and gamma irradiation for Surgiseal, and gamma followed by ethylene oxide for Stylus and Twist) was conducted according to international standards (ISO 11137-2:2006, ISO 11135-1:2008, ISO 11135-2:2008). This ensures the devices are supplied sterile.
• Shelf-Life Determination: A 2-year shelf life was established, implying stability testing was performed, though details of this testing are not provided in this specific document snippet.
• Microbial Barrier Properties (In vitro): In vitro studies showed SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. However, the document explicitly states that clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between microbial barrier properties and a reduction in infection has not been established.

In essence, the "study" for this 510(k) submission is a demonstration that the new devices are substantially equivalent to already approved predicate devices regarding their materials, design, intended use, and performance characteristics, supported by prior testing data and adherence to recognized standards for biocompatibility and sterilization.

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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.

Adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. When SURGISEAL is applied to the skin with the applicator, it polymerizes in minutes.

This document describes the 510(k) premarket notification for the SURGISEAL® Topical Skin Adhesive. The submission primarily addresses a device modification due to a shift in supplier for an equivalent patient-contacting material. Therefore, the "study" mainly focuses on demonstrating that the new material does not negatively impact the device's performance or safety compared to the predicate device.

Here's an analysis based on the provided text, focusing on acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the new material is "equivalent" and that the modified device is "substantially equivalent to the predicate." Therefore, the acceptance criteria for most tests are implicitly that the performance of the modified device (with the new material) must be comparable to or within acceptable limits of the predicate device. Specific numerical targets are not provided in this summary.

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

The provided text does not specify the sample sizes used for the various biocompatibility and performance bench tests.

The data provenance is from bench testing (in vitro) rather than clinical studies, and the location of this testing is not specified, though it would typically be conducted by the manufacturer or a contract research organization. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are typically considerations for clinical data.

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

This information is not applicable as the studies described are bench tests (biocompatibility and performance) and not studies requiring expert interpretation or ground truth establishment based on medical assessment. The "ground truth" for these types of tests is generally defined by standardized methods and analytical measurements.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication in the medical sense.

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

An MRMC comparative effectiveness study was not performed. This submission is for a medical device (topical skin adhesive), not an AI/imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable as the device is a topical skin adhesive, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to clinical or diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not applicable here. For the bench tests described:

• Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and accepted biological responses in specific in vitro and in vivo models.
• Performance Testing: Ground truth is established by standardized material testing methods and measurements (e.g., precise measurement of film thickness, set-time, viscosity, wound closure strength).
• Sterilization and Shelf-Life: Ground truth is established by adherence to ISO 11137-2:2006 and established stability testing protocols.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/machine learning system that requires a "training set."

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

This information is not applicable as the device is not an AI/machine learning system.

Ask a specific question about this device

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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