(127 days)
The Silver Wound Pad is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic).
The Silver Wound Pad is a sterile, single-use wound care dressing for use in moist wound management. The Silver Wound Pad is offered in several configurations including 24" x 36" and 36 " x 36" The dressings are comprised of 5 layers, each performing a specific function; an occlusive synthetic bottom layer (not in contact with patient), two absorbent layers, a layer of a knitted composite fabric (containing polyester on one side and nylon on the other side; coated with 15 ± 5% Antimicrobial AlphaSan® RC 2000 contained in a polyurethane binder) and a contact layer of apertured polyethylene film. These layers are then stitched or heat-sealed together along the edge.
The provided text is a 510(k) summary for the Silver Wound Pad, focusing on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria, detailed device performance metrics in the way typically seen for AI/ML device studies, or the specific study design elements requested (like sample sizes for test/training sets, expert details for ground truth, or MRMC studies).
The "Performance Testing" section broadly states that "Biocompatibility testing was performed... Results... demonstrate that the device is suitable for its intended use. Antimicrobial testing was performed which showed that Silver Wound Pad provides efficacy against gram-positive and gram-negative bacteria." However, it does not provide quantitative acceptance criteria or detailed results of these tests.
Therefore, many of the requested fields cannot be directly extracted from the provided document.
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Study Details for Silver Wound Pad
| Information Requested | Details from the Document |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly stated in terms of quantitative metrics. The overall acceptance criterion appears to be "substantially equivalent" to the predicate device, implying that the safety and effectiveness are comparable. |
| Reported Performance: |
- Biocompatibility: "Results of the biocompatibility tests demonstrate that the device is suitable for its intended use."
- Antimicrobial Activity: "Antimicrobial testing was performed which showed that Silver Wound Pad provides efficacy against gram-positive and gram-negative bacteria."
No specific numerical performance metrics (e.g., reduction percentage, zone of inhibition sizes) are provided. |
| 2. Sample Size (Test Set) and Data Provenance | Not applicable. This device is a wound dressing, not an AI/ML diagnostic. The "testing" mentioned refers to laboratory performance tests (biocompatibility, antimicrobial), not a clinical 'test set' in the AI sense. No information on sample sizes or data provenance for these lab tests is provided. |
| 3. Number of Experts & Qualifications (Ground Truth) | Not applicable. This is not an AI/ML device requiring expert-established ground truth for a diagnostic test set. |
| 4. Adjudication Method (Test Set) | Not applicable. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. This is not an AI/ML device and therefore no MRMC study would be applicable. |
| 6. Standalone (Algorithm Only) Performance | Not applicable. This is a physical wound dressing and does not have an algorithm component. |
| 7. Type of Ground Truth Used | Not applicable. The "ground truth" for this device would be established by validated laboratory assays for biocompatibility and antimicrobial efficacy. |
| 8. Sample Size for Training Set | Not applicable. This is not an AI/ML device. |
| 9. How Ground Truth for Training Set was Established | Not applicable. |
Summary of the Study:
The "study" or "performance testing" described in the 510(k) submission for the Silver Wound Pad primarily consists of two types of laboratory tests:
- Biocompatibility Testing: Performed in accordance with International Organization for Standardization (ISO) recommendations. The results indicated the device's suitability for its intended use. No specific ISO standards or detailed results are provided.
- Antimicrobial Testing: Performed to demonstrate efficacy against gram-positive and gram-negative bacteria. The results showed the Silver Wound Pad "provides efficacy" against these bacteria. No specific test methods or quantitative results (e.g., bacterial reduction percentages or zones of inhibition) are mentioned.
The overarching "study" in the context of this 510(k) is the demonstration of substantial equivalence to the predicate device (Smith & Nephew Exu-Dry® Non-Permeable Pad). The biocompatibility and antimicrobial tests served to support the claim that the addition of a silver-based preservative does not negatively impact safety and effectiveness, and indeed provides an additional functional benefit (antimicrobial control) while maintaining overall equivalence in design, function, and intended use as a wound dressing. The acceptance criteria essentially boil down to passing these standard laboratory tests to a level that supports safety and efficacy for the stated intended use, and ultimately, allowing the FDA to determine substantial equivalence.
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