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derma+flex® QS ™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.

derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity.

The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ 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.

The provided text describes a 510(k) premarket notification for a medical device called derma+flex® QS™ High Viscosity Tissue Adhesive. This type of filing aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a traditional clinical study. Therefore, the information you're looking for, such as a table of acceptance criteria and device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not directly applicable or available in this document.

However, I can extract information about the shelf-life study which included performance testing to demonstrate that changes in the sterilization process did not alter the device's performance over time. This is the closest equivalent to a performance study mentioned in the document.

Here's a breakdown of the relevant information from the document regarding the shelf-life study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantified acceptance criteria and reported performance values. It only lists the types of tests performed to demonstrate that the minor differences in sterilization did not change the performance of the device over time. The implied acceptance criterion would be that the device's performance on these tests remains within pre-defined acceptable ranges or comparable to the predicate for its stated shelf-life.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the document.
• Data Provenance: Not specified in the document. This was a lab-based, pre-clinical study focusing on material and performance characteristics under different sterilization conditions for shelf-life testing. It is not a clinical study involving human patients or data.

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

• Experts: Not applicable. These were laboratory tests against ASTM standards, not expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Lab tests are typically performed according to established protocols and measured objectively, not through human adjudication in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This document describes a 510(k) submission for a tissue adhesive, not an AI or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. This is a physical medical device (tissue adhesive), not an algorithm or software.

7. Type of Ground Truth Used:

• Ground Truth: For the shelf-life studies, the "ground truth" would be the established performance characteristics of the predicate device and the specified limits/ranges for each material property and mechanical strength test as defined by industry standards (ASTM), against which the performance of the new device was compared.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The studies described are for shelf-life validation, where samples of the device are tested over time.

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

• Ground Truth Establishment: Not applicable, as there is no training set. The "ground truth" for showing substantial equivalence relies on comparing the device's characteristics and performance to existing, legally marketed predicate devices and established standards.

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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-ocylt cyanoacrylate) formulation and the colorant D&C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.

This document describes the regulatory submission for SURGISEAL® Topical Skin Adhesive, specifically focusing on a labeling change rather than a new device or a new AI/Machine Learning (AI/ML) device. Therefore, many of the requested criteria related to AI/ML or direct performance studies are not explicitly stated or applicable in this context.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable for this particular submission type:

1. Table of acceptance criteria and the reported device performance:

The document describes performance testing relative to a predicate device and specifications, rather than detailing specific acceptance criteria with numerical targets.

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

The document mentions "Additional bench testing was performed to support the modification to the currently marketed product," but it does not specify the sample size for this bench testing. Similarly, data provenance (e.g., country of origin, retrospective/prospective) is not provided.

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 or provided as this submission is for a labeling change to a medical device (topical skin adhesive), not an AI/ML device requiring expert ground truth for interpretation of images or clinical data. The performance is assessed through bench tests.

4. Adjudication method for the test set:

This is not applicable or provided as the evaluation relies on physical bench tests, not expert interpretation requiring adjudication.

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:

This is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.

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

This is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.

7. The type of ground truth used:

For the performance testing mentioned, the "ground truth" would be defined by the specifications and established performance benchmarks of the predicate device and industry standards for wound closure products. For biocompatibility, the ground truth was established by adherence to ISO-10993 standards.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device and therefore does not involve a training set.

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

This is not applicable as this is not an AI/ML device and therefore does not involve a training set.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "extensive bench performance testing" and biocompatibility testing.

• Biocompatibility Testing: Previously conducted on the currently marketed device, SURGISEAL (K082993), per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The results considered the device non-toxic, non-irritating, non-sensitizing, and biocompatible. No additional biocompatibility testing was deemed necessary for this K123936 submission as the subject device is identical to K082993.
• Performance Testing: "Additional bench testing was performed to support the modification to the currently marketed product." These tests included:
  • Wound closure strength
  • Set-time
  • Linear coverage
  • Film thickness
  • Tissue approximation time

The document states: "In all cases, the modified labeled SURGISEAL Topical Skin Adhesive met specifications and demonstrated equivalence to the predicate device(s)."

The overall conclusion is: "Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be substantially equivalent to its predicate devices from a safety and performance perspective, and has demonstrated that a single layer of the low viscosity product maintains approximation of wound edges."

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