(266 days)
X-Static® SILVERSEAL™ Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
X-Static® SILVERSEAL™ Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Contact Wound Dressing consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.
The provided text is a 510(k) Premarket Notification for a wound dressing, not a study evaluating an AI/ML medical device. Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in the document.
The document describes the device, its intended use, and claims substantial equivalence to predicate devices based on technological characteristics and biocompatibility testing.
Here's what I can extract related to performance in the context of this specific regulatory submission:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied for Biocompatibility) | Reported Device Performance |
|---|---|
| Non-cytotoxic | Passed biocompatibility tests |
| Non-sensitizing | Passed biocompatibility tests |
| Non-acutely intracutaneous reactive | Passed biocompatibility tests |
Explanation of Device Performance:
The document explicitly states: "X-Static® SILVERSEAL™ 1-Layer and 4-Layer Contact Wound Dressings were subjected to standard in vivo biocompatibility tests including cytotoxicity, sensitization, and acute intracutaneous reactivity. All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA). All claims are the result of In Vitro studies and have not been studied in a clinical setting." and "The studies indicated that X-Static® SILVERSEAL™ 1 Layer and 4 Layer Contact Wound Dressings are safe for their intended use."
Regarding the other points in your request:
- 2. Sample sized used for the test set and the data provenance: Not applicable. Biocompatibility tests typically involve animal models (in vivo) and cell cultures (in vitro), but specific sample sizes and provenance for these are not detailed in this summary. The "claims are the result of In Vitro studies" suggesting cell culture or non-living material tests, but no detail on sample size is provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biocompatibility testing relies on standardized protocols and laboratory analysis, not expert consensus on image/diagnostic interpretation.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For biocompatibility, the "ground truth" is defined by the results of standardized biological tests (e.g., cell viability, immune response indicators) against established safety thresholds.
- 8. The sample size for the training set: Not applicable. 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: Not applicable.
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