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The Derma Sciences Medihoney Primary Dressing with Active Manuka Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds such as:

• . diabetic foot ulcers
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
• pressure ulcers / sores (partial and full thickness) .
• . 1st and 2nd degree partial thickness burns
• donor sites, and traumatic and surgical wounds. .

Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are offered in several sizes including 2" x 2", ¾ x 12", 4" x 4" and 4" x 5". The dressings are comprised of honey and sodium alginate.
The proposed Medihoney Primary Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing, and allows intact removal.

The provided document describes a 510(k) premarket notification for a wound dressing, not a medical device that would typically have performance criteria like sensitivity, specificity, or reader studies. The "acceptance criteria" and "study" described in this document relate to demonstrating substantial equivalence to a predicate device, focusing on biocompatibility and formulation changes.

Here's an interpretation based on the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This section is Not Applicable in the context of the provided document. The "tests" mentioned are biocompatibility tests on the device material itself, not a clinical study involving a "test set" of patients or data, nor does it refer to an AI/algorithm-driven device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This section is Not Applicable. There is no mention of human experts establishing ground truth for a test set in the context of this device's evaluation.

4. Adjudication Method for the Test Set

This section is Not Applicable. There is no "test set" for expert adjudication 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

This section is Not Applicable. This document does not describe an AI-driven device or an MRMC study.

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

This section is Not Applicable. This document does not describe an AI/algorithm-driven device.

7. The type of ground truth used

This section is Not Applicable in the traditional sense of a clinical or imaging study. The "ground truth" for the performance claims relates to established scientific and regulatory standards for biocompatibility testing to ensure the safety of the device's components.

8. The Sample Size for the Training Set

This section is Not Applicable. There is no "training set" as this is not an AI/algorithm device.

9. How the Ground Truth for the Training Set was Established

This section is Not Applicable. There is no "training set" or establishment of ground truth for such a set.

Summary of the Study Demonstrated for Substantial Equivalence:

The primary "study" described to demonstrate the device meets acceptance criteria (specifically, being substantially equivalent to a predicate device) is Biocompatibility Testing.

• Acceptance Criteria: The device must be safe for its intended use, as demonstrated by meeting standard biocompatibility requirements.
• Study Performed: Cytotoxicity, sensitization, and irritation testing was conducted on the Derma Sciences Medihoney Primary Dressings.
• Results: The testing was "performed successfully," indicating that the device met the biocompatibility standards and was deemed safe for its intended use.
• Purpose: This testing supported the formulation change from the predicate device, confirming that the new composition does not adversely affect safety.

The basis for calling this a "study" is the regulatory requirement to demonstrate that any changes (in this case, formulation) from a predicate do not raise new questions of safety or effectiveness. The successful completion of these standard biological tests served as the evidence for this device.

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