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The Dermatac™ Drape is an accessory to the following V.A.C.® Therapy Negative Pressure Wound Therapy Systems:

3M™ ActiV.A.C.™, 3M™ V.A.C.® Simplicity, and 3M™ V.A.C.Via™ Negative Pressure Wound Therapy . Systems, which are integrated wound management systems for use in acute, extended and home care settings. . The V.A.C.ULTA™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

When used on open wounds, these systems are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention, by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts.

When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The Dermatac™ Drape is also an accessory to the V.A.C. VERAFLO™ Therapy (Instillation) provided by the V.A.C.ULTATM Therapy Unit.

V.A.C. VERAFLO™ Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

V.A.C. VERAFLO™ Therapy is indicated for patients with chronic, sub-acute and dehisced wounds, partial-thickness burns. ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts.

The Dermatac™ Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C.® Therapy and V.A.C. VERAFLO™ Therapy Systems. The Dermatac™ Drape is a single-use, sterile covering that provides a sealed environment for delivery of these therapies. It also allows for a moist wound environment.

The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone laver expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound skin, thus creating a sealed wound environment.

The therapy systems with which it is used are comprised of the following:

• Software controlled therapy unit that provides negative pressure and, in the case of ● V.A.C. VERAFLO™ Therapy, a pump for controlled delivery of topical wound solutions.
• Disposable canister which collects wound exudate and, in the case of V.A.C. ● VERAFLO™ Therapy, instilled solutions
• Foam dressing for placement into the wound ●
• Semi-occlusive drape that covers the dressing ●
• Tubing set that connects the dressing to the therapy unit. ●

The provided text is a 510(k) premarket notification for a medical device called the Dermatac™ Drape. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study involving AI or human interpretation of medical images.

Therefore, many of the requested points related to AI acceptance criteria, training/test set sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance cannot be answered based on the provided text. The document describes a physical medical device (a wound drape), not a diagnostic algorithm.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a physical device, the "acceptance criteria" are not framed as typical performance metrics for an AI system. Instead, the testing focuses on validating the fundamental functions and safety of the drape.

2. Sample sizes used for the test set and the data provenance:

• Sample sizes: Not explicitly stated for each test. The document refers to "testing" which implies a sample was used, but the exact number of units or iterations is not provided.
• Data provenance: Not specified in terms of country of origin. The studies are described as "non-clinical tests." The document states "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence," implying these were laboratory or benchtop tests rather than patient-based studies.

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

• Not applicable. This is not a study requiring expert interpretation or ground truth establishment in the context of medical image analysis. The tests are physical/chemical performance evaluations.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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. This is a physical medical device, not an AI system. No MRMC study was performed.

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

• No. This is a physical medical device.

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

• The "ground truth" for the performance tests of the physical device would be based on engineering specifications, material science standards, and established biological/chemical safety protocols (e.g., ISO standards for biocompatibility tests). For example, "maintaining negative pressure within specifications" implies a predefined acceptable range, which serves as the "ground truth" for that test.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI system that requires a "training set."

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

• Not applicable.

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