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Under the supervision of a healthcare professional. APIS® / VERIS™ Wound Management Devices are indicated for use in management of wounds, including:
· Full and partial thickness wounds

• · pressure ulcers (stages I -IV)
• · venous stasis ulcers
• · diabetic ulcers
• abrasion
• · surface wounds
• · traumatic wounds (healing by secondary intention)
• · donor site wounds
• · surgical wounds

For over-the-counter use, APIS® OTC / VERISTM OTC Wound Management Devices may be used for:

• minor abrasions
• · lacerations
• minor cuts
• · minor scalds and burns

APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device for the management of wounds, are sterile, single-use devices. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device are conformable solid sheets that are biodegradable and absorbable. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device in its final form, is comprised of a highly purified collagen derivative from porcine skin (gelatin), Manuka honey, and hydroxyapatite (HAp).

The intended use of APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device in the management of wounds is to cover and protect the wound, absorb wound exudate, and provide and maintain a moist wound environment. The structural reinforcement of APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device is achieved through the incorporation of hydroxyapatite into the crosslinked collagen derivative structure. The absorption and moisture-retaining properties are based on the manufacturing process and incorporation of honey into the crosslinked structure.

The device is biodegradable and absorbs into the surrounding tissue. The degradation occurs through natural processes such as enzymatic breakdown, hydrolysis and other chemical/biological reactions depending on wound type and level of exudation.

There is no difference between the APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device except APIS® Wound Management Device and APIS® OTC Wound Management Devices have a thickness of 0.03cm and is the compressed form of VERIS™ Wound Management Device and VERIS™ OTC Wound Management Devices which has a thickness of 0.6cm. In other words, VERIS™ Wound Management Devices and VERIS™ OTC Wound Management Devices are 20 times thicker than the APIS® Wound Management Devices and APIS® OTC Wound Management Devices (dressings).

The provided text is a 510(k) Summary for medical devices (wound management devices) and does not contain information about the performance of an AI/ML powered device. Therefore, I cannot extract the specific details requested regarding acceptance criteria, study design, ground truth establishment, or human reader performance with AI assistance.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Identicality for the Prescription Use Only version of the device compared to its predicate (APIS® Wound Management Device, K182725). The only difference mentioned is a "change in the directions of use between the current instructions for use and the proposed instructions for use" (Page 12, K. Basis for Substantial Equivalence, Rx Only).
• Equivalence with minor technological differences for the Over-the-Counter (OTC) version of the device compared to its predicate (MediHoney Hydrogel Sheet Dressings with Leptospermum Honey, K110546). The document explicitly states that "Technological differences do not result in new questions of safety or effectiveness" (Page 12, K. Basis for Substantial Equivalence, OTC).

The "Performance Data" section (Page 12, J.) primarily states that "Nonclinical testing was performed to demonstrate that APIS® / VERIS™ Wound Management Devices and APIS® OTC/ VERIS™ OTC Wound Management Devices are as safe and effective as the legally marketed predicate devices, including fluid uptake, and conformability." It also mentions "Sterilization validation, distribution testing and shelf-life testing have been completed" and extensive biocompatibility testing. This refers to standard medical device performance testing, not AI/ML model performance.

In summary, the provided text does not contain the information needed to answer your questions about AI device acceptance criteria and study details.

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