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HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as:

• First and second degree burns
• Severe sunburns
• Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears

HEALADEX-P dressing should be used under health care professional direction for the following indications:

• Pressure ulcers, Stage I-IV
• Lower extremity ulcers
• Venous ulcers
• Arterial ulcers
• Ulcers of mixed etiology
• Diabetic ulcers
• Donor sites and skin grafts
• Burns caused by radiation oncology procedures

HEALADEX-P is a sterile wound-dressing comprised of carboxymethylcellulose and lyophilized formulated porcine plasma, which is island mounted on moisture vapor permeable adhesive film dressing sheet coated with acrylic adhesive and a polyurethane protective film. This dressing aids the healing process by maintaining a moist environment at the wound site.

HEALADEX-P dressing is individually packaged in a foil moisture barrier chevron peel pouch appropriately labeled with lot number and expiration date. Five units are packaged into a cardboard box with Instructions for Use (IFU).

The provided text is a 510(k) summary for a medical device called HEALADEX®-P Occlusive Dressing. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description and intended use.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The text clearly states: "Safety testing was conducted in accordance with ISO 10993 Part1 in support of the claim of biocompatibility for this product." This indicates the nature of the testing performed, but it's not a performance study of the wound healing properties or a comparative effectiveness study as typically found in submissions for AI/ML-driven devices or those requiring clinical efficacy data for their primary function beyond safety.

Therefore, I cannot populate the table or answer most of the questions you've asked because the information is not present in the provided document.

To directly address your request given the provided input:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Not specified in the provided text.
   • Reported Device Performance: Not specified in the provided text. The document focuses on demonstrating biocompatibility and substantial equivalence to legally marketed predicate devices, not on proving a specific performance metric against a defined acceptance criterion.

2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described. The document mentions "Safety testing" in accordance with ISO 10993 Part 1, which typically involves in-vitro and in-vivo tests on animal models or cell cultures for biocompatibility, not human patient data for device performance as you might expect for an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.

4. Adjudication method: Not applicable. No test set requiring adjudication is described.

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. An MRMC study was not done. This device is a physical wound dressing, not an AI/ML-driven diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device is a physical wound dressing, not an algorithm.

7. The type of ground truth used: Not applicable for performance evaluation in the context of your questions. For biocompatibility testing, the "ground truth" would be established by the results of the ISO 10993 tests against accepted biological safety limits.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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