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DERMA+FLEX™ Gel Adhesive is indicated for OTC use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

DERMA+FLEX™ Gel Adhesive is a sterile, clear, high viscosity, flexible, liquid topical bandage composed of a blend of 2-Octyl and N-Butyl cyanoacrylate monomers with an octyl cyanoacrylate polymer, tributyl citrate (a plasticizer) and containing D&C violet #2 pigment. DERMA+FLEX™ is supplied in 0.5g single patient use aluminum tubes with (2) self-piercing applicator caps (a dauber cap and a nozzle cap). Each sterile single use aluminum tube is packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.

The provided text describes the 510(k) summary for the DERMA+FLEX™ Gel Adhesive and the FDA's clearance letter. It focuses on establishing substantial equivalence to predicate devices and provides details on the device description, indications for use, and a summary of biocompatibility testing. It does not contain information about acceptance criteria for performance, a study to demonstrate device performance in terms of efficacy or effectiveness, or details about sample sizes, expert involvement, or adjudication methods for performance studies.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or details about performance studies, multi-reader multi-case studies, or standalone algorithm performance.

However, I can extract the information related to the biocompatibility testing that was performed:

1. Table of acceptance criteria and the reported device performance (for biocompatibility testing):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• The document describes in vitro and in vivo biocompatibility tests using cell lines (L929 agar overlay test) and animal models (Murine Local Lymph Node Assay and Intracutaneous Inject). Specific sample sizes for these tests are not provided in the document.
• Data provenance is not specified. These are standard laboratory tests typically conducted under controlled conditions and would likely be prospective for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not applicable or not provided for biocompatibility testing. Biocompatibility tests rely on established scientific protocols and quantitative measurements, not expert consensus on qualitative data.

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

• This information is not applicable or not provided for biocompatibility testing.

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 MRMC comparative effectiveness study was mentioned or performed. The device is a "Liquid Bandage" and does not involve AI or human image interpretation.

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

• Not applicable. The device is a physical product (liquid bandage), not an algorithm or AI.

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

• For biocompatibility testing, the "ground truth" is established through:
  • Validated biological assays: such as cell viability assays (L929), immune response assays (LLNA), and irritation potential assays (intracutaneous injection).
  • Interpretation against international standards: (e.g., ISO 10993-5, USP 24) and regulatory guidelines.

8. The sample size for the training set:

• Not applicable. This pertains to algorithm development. For a physical medical device, there isn't a "training set" in the computational sense. The "development" would involve formulation and bench testing.

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

• Not applicable. See point 8.

In summary, the provided document details biocompatibility testing results to demonstrate the safety of the DERMA+FLEX™ Gel Adhesive, not its performance in terms of efficacy, which is typically established through clinical studies not present in this 510(k) summary. The focus of the 510(k) was on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (biocompatibility).

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