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TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.

TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.

The provided text describes a 510(k) premarket notification for a medical device called "TearRepair Liquid Skin Protectant." This submission seeks to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "Marathon No Sting Liquid Skin Protectant" (K133443).

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML powered device. The "TearRepair Liquid Skin Protectant" is a physical medical device (liquid bandage) and not an AI/ML-powered device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of device in the provided text.
2. Sample size used for the test set and the data provenance: Not provided, as this is not an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as this is not an AI/ML study.
4. Adjudication method for the test set: Not provided, as this is not an AI/ML study.
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: Not applicable, as this is not an AI/ML study.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

The document focuses on non-clinical bench testing and biocompatibility testing for a physical liquid skin protectant, as summarized below:

Summary of Non-Clinical Testing

The following tests were performed to demonstrate safety based on current industry standards, indicating that TearRepair is substantially equivalent to the predicate device:

Bench Testing:

• Mechanical Testing/Adhesive strength testing
• Heat of Polymerization
• Moisture Vapor Transmission Rate
• Setting Time of Liquid Skin Protectant
• Applicator Functionality

Biocompatibility (ISO 10993 series):

• Cytotoxicity (ISO 10993-5)
• Sensitization (ISO 10993-10)
• Irritation (ISO 10993-10)
• Acute systemic toxicity (ISO 10993-11)
• Material-mediated pyrogenicity (ISO 10993-11, USP )
• Subacute toxicity (ISO 10993-11)
• Implantation (ISO 10993-6)

Acceptance Criteria and Reported Device Performance
The document states that "No FDA performance standards have been established for TearRepair." Therefore, while specific tests are listed, the explicit quantitative acceptance criteria and the numerical reported performance for each test are not provided in the given text. The conclusion merely states that the results "indicate that TearRepair is substantially equivalent to the predicate device" and "does not raise different questions of safety or effectiveness compared to the predicate devices."

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BondEase® Topical Skin Adhesive is intended for topical use only, to hold together the skin edges of incisions and lacerations that are under minimal tension and easily approximated. Where significant tension exists on incisions or lacerations, BondEase® Topical Skin Adhesive should be used in conjunction with deep dermal stiches.

BondEase® Topical Skin Adhesive is a sterile, liquid topical skin closure device composed of a methylidene malonate monomer formulation and the colorant D&C Green #6. It is provided in a single-use applicator, packaged in a foil pouch. The applicator is comprised of a crushable glass ampoule contained within a plastic vial with attached applicator tip and handle. BondEase® is applied to the skin as a viscous liquid which polymerizes to bond approximated wound edges within minutes. In vitro studies have shown that BondEase® acts as a bacterial barrier as long as the adhesive film remains intact.

This document describes the BondEase® Topical Skin Adhesive and presents data to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the primary endpoint were established around demonstrating non-inferiority to conventional wound closure devices (CWCD) with a 10% margin.

Additional secondary endpoints and their performance are summarized below, though specific "acceptance criteria" for these were not explicitly stated as non-inferiority targets:

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

• Sample Size (Test Set):
  • Randomized (Total): 162
  • Randomized and treatment applied (Total): 159
    • BondEase: 105 subjects
    • CWCD: 54 subjects
  • Intent-to-treat population (ITT): 159 subjects (BondEase: 105, CWCD: 54)
  • Per protocol population (PP): 153 subjects (BondEase: 100, CWCD: 53)
• Data Provenance: Prospective, randomized, controlled, open-label study. The document does not specify the country of origin of the data, but it is an FDA submission for a US market.

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

The ground truth for the clinical study was established by investigators and a blinded clinician.

• Wound Apposition: Determined by the "investigator." The qualifications of these investigators are not explicitly stated, but it's implied they are healthcare professionals treating the wounds.
• Cosmetic Outcome: Determined by a "blinded clinician." The qualifications of this clinician are not explicitly stated.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. Outcomes (wound apposition and cosmetic outcome) were assessed by single parties (investigator for apposition, blinded clinician for cosmesis), rather than multiple experts with a defined adjudication process.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The study compared the device against conventional wound closure methods (CWCD) with human application, but it did not assess the comparative effectiveness of human readers improving with or without AI assistance. The device itself is a topical adhesive; there is no AI component.

6. Standalone Performance

Yes, a standalone performance was done for various characteristics of the BondEase® Topical Skin Adhesive, independent of human application in a clinical setting. This is detailed under "Nonclinical Performance Data":

• Performance Bench Testing: Included tests of adhesive strength, degradation rate, heat of polymerization, and bacterial barrier performance.
• Biocompatibility Testing: Conducted per ISO 10993 guidelines, showing the device to be non-cytotoxic, non-irritating, non-pyrogenic, with no toxicological effect, non-hemolytic, and non-genotoxic.
• Porcine Study: Demonstrated that BondEase® did not inhibit normal wound closure and healing.

7. Type of Ground Truth Used

• For Nonclinical Tests: Ground truth was based on laboratory measurements, validated standards (e.g., ISO 10993 guidelines for biocompatibility), and observations in animal models (porcine study).
• For Clinical Study:
  • Wound apposition: Clinical assessment by the investigator.
  • Cosmetic outcome: Clinical assessment by a blinded clinician using a validated scale (Hollander JE, et al, 1995).
  • Adverse events: Clinically observed and reported events.

8. Sample Size for the Training Set

No "training set" in the context of an AI/algorithm is mentioned since this is a topical skin adhesive product. The device itself does not employ an AI algorithm. The closest equivalent would be the data used for the development and bench testing of the adhesive formulation, or prior clinical experience informing the study design. However, the document does not provide a specific sample size for such a "training set."

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

As there is no AI algorithm and thus no explicit "training set" in the computational sense, this question is not applicable. The development and testing of the adhesive material itself relied on chemical and biological principles, and extensive non-clinical testing (bench and animal studies) as described under "Nonclinical Performance Data," where ground truth was established through validated test methods and established standards.

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