(495 days)
The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
The SureSkin III with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ III with Silver THIN wound dressings are indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.
The SureSkin™ III with Silver wound dressings are also indicated for use on second degree burns and donor sites.
The SureSkin III with Silver Wound Dressings are identical to the SureSkin II products with the exception that the formulation has been slightly modified to include silver. The SureSkin III formulation includes the same well-known materials that are used in other hydrocolloid wound dressings. Polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing. The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.
This is a 510(k) premarket notification for a medical device (wound dressing), not an AI/ML powered device. As such, most of the requested information regarding AI/ML study design, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, is not applicable or not present in the provided document.
However, I can extract information related to the device's performance testing and acceptance criteria as described for this type of medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Antimicrobial Effectiveness | Antimicrobial effectiveness testing (USP Methods) | "showed that the SureSkin III with Silver Wound Dressings provide an effective microbial barrier in the wound pad." |
| Microbial Barrier | Microbial Barrier testing (USP Methods) | "showed that the SureSkin III with Silver Wound Dressings provide an effective microbial barrier in the wound pad." |
| Biocompatibility | Biocompatibility testing (International Organization for Standardization recommendations) | "Results of the biocompatibility tests demonstrate that the device is suitable for its intended use." |
| Substantial Equivalence | Comparison to Predicate Devices (SureSkin II, Contreet, Xylos Cell Antimicrobial) | "The SureSkin III with Silver Wound Dressings... are identical in design, function and intended use to the commercially available predicate SureSkin II wound dressings. The only difference is the slight change in formulation of the materials... The only differences between the new SureSkin III with Silver products and the predicate devices are slightly different formulations, which are minor and do not affect safety and effectiveness of the device." |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A) for AI/ML powered device studies.
- For the performance testing mentioned (Antimicrobial effectiveness, Microbial Barrier, Biocompatibility), the document does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective). These are typically laboratory-based tests following specific protocols, not clinical studies with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A for AI/ML powered device studies.
- Ground truth as typically understood in AI/ML validation (e.g., expert consensus on image annotations) is not relevant here. The "ground truth" for this device's performance is established by the results of standardized laboratory tests and comparisons to predicate devices.
4. Adjudication method for the test set
- N/A for AI/ML powered device studies.
- Adjudication methods (like 2+1, 3+1) are common in clinical trials or expert review of AI outputs. This document describes laboratory testing; arbitration or adjudication of results would follow standard laboratory quality control and protocol adherence, not a multi-expert consensus process as implied by the question.
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, an MRMC comparative effectiveness study was not done. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML powered device with an algorithm. Performance tests were done on the physical device itself.
7. The type of ground truth used
- For this device, the "ground truth" is established by:
- Standardized Test Methods: Adherence to established USP methods for antimicrobial and microbial barrier testing.
- International Standards: Compliance with International Organization for Standardization (ISO) recommendations for biocompatibility.
- Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices based on design, function, intended use, and material composition.
8. The sample size for the training set
- N/A for AI/ML powered device studies.
- There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- N/A for AI/ML powered device studies.
- There is no training set for this device.
N/A