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The new oxygen enriched topical hydrophilic closed cell foam wound dressings are indicated for use in the management of acute and chronic wounds. The products are intended as a primary topical wound contact dressings for use in the management of wound exudates for wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, puncture wounds, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

Over the Counter Use: AcryDerm Absorbent Oxygen Dressings are intended to be used on minor wounds including lacerations scrapes, skin tears, abrasions, blister wounds, and minor burns.

AcryDerm Absorbent Oxygen Dressing is a single use, sterile, hydrophilic absorbent closed cell foam enriched with gaseous and dissolved oxygen intended for use in the management of wounds. The oxygen enriched product is intended to be used as a topical moisture management wound dressing.

The provided text describes a 510(k) premarket notification for the AcryDerm Absorbent Oxygen Dressing. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a detailed clinical study with performance metrics in the way a clinical trial for a novel AI device might.

Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document, as the regulatory pathway for this specific wound dressing does not typically involve such studies for its clearance.

Here's a breakdown of what can be extracted and what cannot, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The document describes a medical device (wound dressing) and its regulatory clearance process, which primarily relies on substantial equivalence to predicate devices and adherence to safety/manufacturing standards, rather than performance evaluation against a "test set" in the context of an AI study. There is no mention of a test set, data provenance, or patient data.

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 or ground truth established by experts is mentioned for this device.

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

• Not Applicable. No test set or related adjudication method is mentioned.

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 a wound dressing, not an AI diagnostic or assistive device for human readers. No MRMC study was conducted.

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

• Not Applicable. This is a physical wound dressing, not an algorithm.

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

• Not Applicable. No ground truth in the context of diagnostic or analytical performance evaluation is relevant or mentioned for this product. The 'ground truth' for this type of device is its ability to meet material specifications, safety, and manufacturing quality.

8. The sample size for the training set

• Not Applicable. This is a physical wound dressing, not an AI model requiring a training set.

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

• Not Applicable. No training set or associated ground truth establishment is relevant or mentioned.

Summary of the Study (as described in the document):

The "study" described in the 510(k) submission is not a clinical trial in the traditional sense of evaluating efficacy or diagnostic accuracy, but rather a demonstration of substantial equivalence to legally marketed predicate devices. The "study" involves:

• Technological Characteristics Comparison: The device's ability to absorb 5 to 10 times its weight in moisture (in vitro absorbency studies) is compared to similar characteristics of predicate devices.
• Safety and Biocompatibility Testing: The product underwent testing to meet or exceed safety and biocompatibility guidelines as provided in the ISO standard (Biological Evaluation of Medical Devices) and NIH Publication 99-4494.
• Sterility Assurance: The product's sterility assurance conforms to AAMI/ANSI/ISO 11137-1994.
• Manufacturing Practices: A commitment to manufacturing according to good manufacturing practices.

The regulatory clearance (K082459) was granted based on these demonstrations, concluding that the AcryDerm Absorbent Oxygen Dressing is "substantially equivalent" to predicate devices without requiring new clinical efficacy studies or performance standards to be met beyond safety and manufacturing quality.

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