(77 days)
The Derma Sciences Medihoney Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and is indicated for the management of 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 Dressing with Active Manuka Honey are sterile, wound care dressings for use in moist wound management. The Derma Sciences Medihoney Dressing with Active Manuka Honey are offered in several sizes including .5, 1, and 1.5 oz. sizes.
The proposed Medihoney 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 provided text is a 510(k) Summary for Derma Sciences Medihoney Dressings with Active Manuka Honey. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study typically would. Instead, it refers to biocompatibility testing.
Here's an attempt to answer your questions based only on the provided text, acknowledging where information is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for performance in the context of efficacy for wound healing. It focuses on biocompatibility.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility for Intended Use: | The biocompatibility testing performed (sensitization, irritation, cytotoxicity, implantation) supports the device's safe use. |
| Sensitization (no significant reaction) | Successfully performed. |
| Irritation (non-irritant or minimal irritant) | Successfully performed. Macroscopic reaction was not significant compared to control; slight compared to negative control. Microscopically, classified as non-irritant compared to control, slight irritant compared to negative control. |
| Cytotoxicity (expected reaction due to osmotic effect) | A moderate cytotoxic reaction was observed using 100% honey dressings. This is expected due to the osmotic effect of honey on cells in culture (maximum tolerance ~2% honey concentration for cells in culture). The document explicitly states: "However, neither sugar nor honey used on open wounds causes any adverse effects." Implantation testing was initiated to further support safe use given this in-vitro finding. |
| Substantial Equivalence (to predicate devices K072956 & K053095): | The device is considered "essentially identical" to the predicate devices, with differences limited to a "slight formulation change" (100% Manuka Honey vs. 95% Manuka Honey and 5% calcium alginate). This change "does not represent a significant change in technological characteristics" and does not "affect the safety and effectiveness of the device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "biocompatibility testing." While it refers to "implantation testing," specifics such as the number of subjects (animal or human), data provenance (country, retrospective/prospective), or specific sample sizes for sensitization, irritation, or cytotoxicity tests are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The biocompatibility tests are laboratory-based and likely follow standardized protocols for assessment, rather than relying on expert consensus for "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the biocompatibility tests.
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 MRMC study was mentioned. This 510(k) summary is for a physical wound dressing, not an AI-powered diagnostic device, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility testing:
- Sensitization and Irritation: Likely based on standardized grading scales of physiological reactions.
- Cytotoxicity: Measured in vitro using cell culture reactions.
- Implantation testing: Macroscopic and microscopic assessment of tissue reaction, likely against established criteria for irritancy. This is not "ground truth" in the sense of clinical outcomes, but rather a safety assessment.
There is no mention of clinical outcomes data or pathology results specifically for proving the efficacy of this new formulation. The device relies on substantial equivalence primarily due to minor formulation changes and the established safety of manuka honey as a wound dressing.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
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