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ProDerma Liquid Bandage is indicated for over-the-counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

ProDerma Liquid Bandage, a formulated Cyanoacrylate adhesive, is a violet tinted, clear liquid topical bandage composed of 2-Octyl and N-Butyl Cyanoacrylate monomers, a plasticizer and D&C violet #2 pigment.

ProDerma is packaged in a single use applicator containing up to 0.5 grams of product. The single use applicator is constructed in the shape of “tear drop” with the flat bottom side made of a flexible laminated film of Pet/AL/Nitrile and a flexible laminate of either Nitrile/PE or Nitrile/PP/PE formed as a blister on the top side with a polyurethane foam sponge for applying the liquid bandage. Each applicator is individually packaged in a blister with a Tyvek backing. The applicators are packaged in a box with a quantity ranging of 6 to 24 per box depending on the customer's requirements. The applicator is opened by folding over the packet at the narrow end under the foam sponge onto itself. The liquid flows into the foam sponge and is control by the user as pressure is applied to the applicator. ProDerma is then applied to the area in need.

Applicators sterilized to a Sterilization Acceptance Level (SAL) of 10° via commercially available irradiation facilities.

The provided text describes the 510(k) summary for the ProDerma Liquid Bandage (K063202). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way a medical AI/ML device submission would.

Therefore, the following information is not applicable or not provided in the given text:

• A table of acceptance criteria and the reported device performance: This is a submission for a traditional medical device (liquid bandage) and not an AI/ML device. Performance is assessed through chemical properties and biocompatibility, not statistical metrics like sensitivity/specificity.
• Sample size used for the test set and the data provenance: Not applicable for a chemical product's substantial equivalence review.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For a chemical product, ground truth would relate to material properties and biological response, not diagnostic accuracy.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, based on the provided text, we can infer some information relevant to the device's "performance" and how its safety and effectiveness were evaluated:

Acceptance Criteria (Implied by Substantial Equivalence and Testing Summary):

The acceptance criteria for a Class I general hospital device like a liquid bandage primarily revolve around:

1. Safety (Biocompatibility): The device must not cause adverse biological reactions when in contact with the skin.
2. Sterilization Efficacy: If sterilized, the process must achieve a specified sterility assurance level (SAL).
3. Functional Equivalence: The device must perform its intended function (forming a cover, polymerization time) similarly to its predicate devices.
4. Material Composition: The components should be known and similar to legally marketed devices.

Study that Proves the Device Meets the Acceptance Criteria:

The key study mentioned is the testing summary which supports the substantial equivalence claim.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

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

• Sample Size for Test Set: Not specified in the document. Biocompatibility and sterility testing typically involve specific sample sizes dictated by the standards (ANSI/AAMI/ISO 10993, 11137, 11737) but these are not enumerated here.
• Data Provenance: Not specified, but standard testing is generally conducted in controlled laboratory environments. The document does not indicate retrospective or prospective clinical data for performance evaluation in the context of human use outcomes.

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

• Not applicable / Not specified. The evaluation here relies on standardized laboratory tests and comparisons to predicate devices, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set:

• Not applicable / Not specified.

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

• No. This type of study is relevant for diagnostic imaging or AI devices, not for a liquid bandage.

6. Standalone (Algorithm Only) Performance:

• No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Biocompatibility Standards: Ground truth is established by adherence to in vitro and in vivo testing protocols defined by international standards (ANSI/AAMI/ISO 10993).
• Sterilization Standards: Ground truth is established by adherence to validation protocols defined by international standards (ANSI/AAMI/ISO 11137 & 11737).
• Predicate Device Characteristics: For functional aspects (like polymerization time), the "ground truth" or benchmark is the performance characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not applicable / Not specified. This concept is for AI/ML models, not for a traditional medical device. There is no "training set" in the context of this 510(k) submission.

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

• Not applicable / Not specified.

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