(88 days)
For over-the-counter use, Silverlon® Wound Contact Dressing may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Under the supervision of a health care professional, Silverlon® Wound Contact Dressing may be used for the management of: Silverlon® Wound Contact Dressings provide an effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
Silverlon® Contact Wound Dressings are made of flexible, elastomeric, sterile, silver plated fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately one percent silver oxide. The coating of silver is circumferential between 0.8 and 1.0 um thick. Silverlon® 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 Silverlon® Wound Contact Dressings consists of a thin layer of metallic silver containing approximately one percent silver oxide that provides effective protection of the dressing against microbial contamination.
The provided text is a 510(k) summary for the Silverlon® Antimicrobial Barrier Wound Contact Dressing and related products. It focuses on demonstrating substantial equivalence to a predicate device and provides performance data primarily related to biocompatibility.
Here's an analysis of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In vivo biocompatibility (cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, tissue compatibility) | "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), Northwood, Ohio. The studies indicated that Silverlon® Contact Wound Dressings are safe for their intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each biocompatibility test.
- Data Provenance: The studies were performed by North American Science Associates, Inc. (NAMSA), Northwood, Ohio, which suggests the studies were conducted in the USA. The text does not specify if they were retrospective or prospective, but in vivo biocompatibility studies are typically prospective experimental studies.
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. The performance data presented is for biocompatibility tests, which are objective laboratory (in vivo) measurements and do not rely on expert interpretation for "ground truth" in the same way clinical diagnostic studies would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies where human interpretation of medical data (e.g., images) is involved, not for standardized biocompatibility testing.
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-assisted diagnostic tool.
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. The performance described is for the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" would be the observed biological reactions and measurements against established safety limits and criteria as defined by ISO 10993 standards. It's objective, not based on expert consensus, pathology, or outcomes data in the clinical sense for this specific evaluation.
8. The sample size for the training set
Not applicable. This device is a wound dressing, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this information pertains to AI models, not physical medical devices like wound dressings.
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