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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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