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The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds.

For over the counter use, Medihoney Gel Dressings with Active Manuka Honey may be used for:

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

Under the supervision of a healthcare professional, The Derma Sciences Medihoney Gel Dressings provide a moist environment conducive to wound healing and are indicated for light to moderate exuding wounds. The Medihoney Gel Wound Dressings are intended for the management of the following:

• 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 Gel Dressings with Active Manuka Honey are sterile, wound care dressings for use in moist wound management. The Derma Sciences Medihoney Gel Dressing with Active Manuka Honey is offered in 10, 20, and 25 oz tubes sizes. The dressings are comprised of honey an emulsifier and a surfactant.

The proposed Medihoney Gel 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.

The proposed Medihoney Gel Wound Dressings with Active Manuka Honey are comprised of 80% Active Manuka Honey, 15% Myristyl Myristate and 5% Plantacare 810 compared to the parent Medihoney Primary Dressings which are comprised of 100% honey, 80% Active Manuka Honey and 20% sodium alginate powder or 95% w/w Active Manuka Honey and 5% w/w Calcium Alginate. The addition of the Myristyl Myristate and Plantacare 810 increases the viscosity of the gel which helps to improve adherence to the wound bed.

This document is a 510(k) Summary for a medical device called "Derma Sciences Medihoney Gel Dressings with Active Manuka Honey." It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new performance criteria through a standalone clinical study with acceptance criteria and reported performance metrics in the way a novel diagnostic or AI device might.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not applicable in this context. The document describes a formulation change and demonstrates biocompatibility and substantial equivalence to existing devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of data is not provided in the document as it is a 510(k) submission for a device with a formulation change, relying on substantial equivalence to predicate devices, not on proving new clinical efficacy metrics against specific acceptance criteria.

The document states:

• "Biocompatibility testing performed to support the formulation change for the modified dressings demonstrates that the Medihoney Gel Dressings with Active Manuka Honey are safe for their intended use."
• "The biocompatibility testing included cytotoxicity, implantation, sensitization, and irritation testing (repeat patch insult testing)."

There are no quantitative acceptance criteria or reported values for these tests mentioned in the provided text. The output is a qualitative statement of safety for its intended use.

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

Not Applicable in the context of clinical performance demonstrating efficacy against acceptance criteria. The performance testing mentioned is biocompatibility. Details on the sample size and provenance for the biocompatibility tests are not provided in this summary.

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

Not Applicable. This document does not describe a study involving expert-established ground truth for a test set. The determination is based on the safety and substantial equivalence of the material.

4. Adjudication method for the test set

Not Applicable. No test set requiring adjudication in the context of clinical performance 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

Not Applicable. This is not an AI device, and no MRMC study is described.

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

Not Applicable. This is a medical dressing, not an algorithm, so standalone performance is not relevant in this context.

7. The type of ground truth used

For biocompatibility testing, the "ground truth" would typically be established by standardized laboratory methods and benchmarks for toxicology (cytotoxicity, irritation, sensitization) and material compatibility (implantation). These are widely accepted scientific standards, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not Applicable. This document does not describe a machine learning algorithm or a training set.

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

Not Applicable. As above, no training set for a machine learning model is involved.

Summary of Device and Evidence Presented:

The document describes the Derma Sciences Medihoney Gel Dressings with Active Manuka Honey.

• Acceptance Criteria/Performance: The primary "acceptance criteria" for a 510(k) submission of this nature are demonstrating substantial equivalence to existing predicate devices and showing that biocompatibility testing (cytotoxicity, implantation, sensitization, and irritation) supports the safety of the modified formulation for its intended use. The document states that the biocompatibility testing demonstrates that the Medihoney Gel Dressings... are safe for their intended use. There are no quantitative performance metrics against specific acceptance criteria reported in this summary.
• Study: The "study" mentioned is biocompatibility testing. This testing was performed to support a slight formulation change in the product (addition of Myristyl Myristate and Plantacare 810 to increase viscosity and adherence to the wound bed).
• Purpose: The goal was to prove that the new formulation maintains safety and efficacy comparable to the predicate devices, thereby establishing substantial equivalence for the same intended uses.

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