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The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including microorganisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).

The ARMIS VeriCyn® Wound Wash is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, no-odor aqueous solution that is used to remove debris, including microorganisms from wounds though the use of a lavage system. ARMIS VeriCyn® Wound Wash contains: Hydrogen Peroxide, Acetic Acid, Disodium EDTA and Purified water. VeriCyn® Wound Wash has been tested for compliance with ISO 10993.

The provided text describes information for a 510(k) submission for the Armis VeriCyn® Wound Wash. Based on the content, this is a medical device (a wound wash solution) and not an AI/ML device, therefore, many of the requested criteria (like ground truth, experts, MRMC studies, training set, etc.) are not applicable.

However, I can extract the relevant acceptance criteria and details of the non-clinical testing performed to establish substantial equivalence.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating substantial equivalence to a predicate device (Next Science™ Irrigation Solution) through non-clinical testing, ensuring safety and effectiveness for its intended use. The "reported device performance" refers to the results of these non-clinical tests.

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

Not applicable for this type of device (wound wash solution). The "test set" here refers to the samples of the wound wash solution and materials that underwent physical, chemical, and biological testing, not a dataset of patient images or clinical cases. The provenance of the data is from specific laboratory tests conducted on the device components and the final product, as detailed under "Non-Clinical Tests Performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No expert consensus "ground truth" as typically understood for AI/ML devices is relevant here. The standards for testing (e.g., ISO 10993, USP , , ) provide the "ground truth" of performance criteria, and the tests themselves are conducted by qualified laboratory personnel following these established protocols.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials involving human interpretation, often for AI/ML device validation. For this wound wash solution, performance is assessed against established physical, chemical, and biological standards through laboratory 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

Not applicable. This is not an AI/ML device; it is a physical wound wash solution. MRMC studies are used to evaluate diagnostic or screening AI/ML devices.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established international and national standards and test methodologies for medical device safety, biocompatibility, and functional performance. These include:

• ISO 10993 series: For biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity).
• USP : For Preservative Effectiveness.
• USP and : For Bioburden.
• Internal specifications: For physical properties like Clarity, Color, pH, and Viscosity, which are then compared to the predicate or deemed safe.
• Functional wound-wash study: To demonstrate mechanical removal of debris.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML algorithm.

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

Not applicable. This device does not have a training set.

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The VeriFixx™ Small Bone Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VeriFixx™ SBI is single use, gamma sterilized device that is surgically implanted into the intramedullary canal of the bones in the toe to create a fusion and provides stability and maintain the alignment of bone during the healing process. The device is a solid, non-threaded implant that has a superior surface protrusion known as the dorsal fin, which is intended to maintain alignment of the joint during the healing process.

The provided text describes a medical device, the VeriFixx™ Small Bone Implant, and its 510(k) summary for FDA clearance. However, it does not contain information about software or AI, nor does it provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI-based device's performance.

The document is purely a regulatory submission for a physical medical implant, focusing on its substantial equivalence to a predicate device based on bench testing.

Therefore, I cannot extract the requested information from the provided text.

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