(321 days)
DressSkin is intended for the management of wounds that include:
- Partial and full thickness wounds
- Pressure, diabetic, and venous ulcers
- Second-degree burns
- Surgical wounds-donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds
- Draining wounds
DressSkin is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed by the surgeon to meet the individual patient's needs.
This document is a 510(k) Premarket Notification for a wound dressing device named DressSkin™. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving effectiveness through clinical studies with acceptance criteria in the same way a new drug or novel high-risk device might.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in the typical format of a clinical trial (e.g., target sensitivity, specificity, or outcome measures for wound healing). Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" reported is related to biocompatibility and manufacturing safety.
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (from text) |
|---|---|
| Substantial Equivalence (Design & Intended Use) | "DressSkin™ is substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds." |
| Intended use for various wound types is identical to predicate devices. | |
| Biocompatibility | "A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of DressSkin™." Tests included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity. |
| Viral Inactivation (Manufacturing Safety) | "The manufacturing methods for DressSkin™ were also tested by an independent laboratory to assure safe levels of viral inactivation." |
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 does not describe a clinical study with a "test set" in the context of device performance metrics like sensitivity or specificity.
- For Biocompatibility and Viral Inactivation Tests: The sample sizes for these laboratory tests are not specified in the provided text. These are typically in-vitro or animal studies, not human clinical trials.
- Data Provenance: Not applicable in the context of a clinical test set. The laboratory tests were conducted by "an independent certified laboratory" and "an independent laboratory," but the country of origin is not specified. They would generally be prospective for the specific purpose of the submission.
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)
Not applicable. This submission does not involve expert-established ground truth for a clinical test set. The evaluation is based on laboratory testing for biocompatibility and manufacturing safety, and a comparison of design and intended use to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process 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 device is a wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical wound dressing and does not involve any algorithm or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily:
- Predicate Device Characteristics: The established design, materials, and intended use of the predicate devices (SIS Wound Dressing II and Fibracol Plus Collagen Wound Dressing) serve as a de-facto "ground truth" for comparison.
- Standard Biocompatibility & Safety Testing: Ground truth is established by recognized international standards (e.g., ISO standards for biocompatibility) that define acceptable levels for cytotoxicity, sensitization, etc., as determined by the independent certified laboratories.
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. No training set is involved.
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