(169 days)
Silverlon™ 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).
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™ Contact Wound Dressings consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. Silverlon™ 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 describes the 510(k) Premarket Notification for the Silverlon™ Contact Wound Dressing. However, it does not contain specific acceptance criteria, a detailed study report comparing device performance against those criteria, or the methodology typically associated with AI/ML device evaluations.
The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will answer what can be extracted and clearly state what information is missing.
Request Analysis and Information Extraction
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The submission is focused on demonstrating "substantial equivalence" to existing predicate devices (Arglac, Acticoat, Tegapore) rather than meeting specific quantifiable performance targets. The "acceptance" by the FDA is based on this finding of substantial equivalence and adherence to general controls and specific labeling limitations.
- Reported Device Performance: Biocompatibility test results are described.
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 specified. The document mentions "standard in vitro and in vivo biocompatibility tests" but does not detail the number of samples or subjects used in these tests.
- Data Provenance: Not specified, although the testing was conducted by North American Science Associates, Inc. (NAMSA), Northwood, Ohio, USA. The study type (retrospective/prospective) is not indicated, but given it's biocompatibility testing for a medical device, it would typically be prospective pre-clinical testing.
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 type of information is typically relevant for studies involving subjective human assessment or diagnostic accuracy, often with AI. The provided document details biocompatibility testing, which relies on standardized lab methods rather than expert consensus on ground truth in the way a diagnostic AI would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Similar to point 3, adjudication methods are used to establish ground truth in subjective assessments. Biocompatibility testing results are typically objective measurements.
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: The device described (Silverlon™ Contact Wound Dressing) is a physical wound dressing, not an AI/ML diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth for Biocompatibility: The "ground truth" for the performance claims (safety and substantial equivalence) relies on the results of the "standard in vitro and in vivo biocompatibility tests including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study)." These tests follow ISO 10993 standards and represent scientifically established methods to determine biological responses to medical devices. The "ground truth" is therefore derived from standardized biological and chemical assays.
8. The sample size for the training set
- Not Applicable: This concept applies to AI/ML models, not physical medical devices.
9. How the ground truth for the training set was established
- Not Applicable: This concept applies to AI/ML models, not physical medical devices.
Summary Table: Acceptance Criteria and Device Performance
Since explicit acceptance criteria are not provided, I will interpret "acceptance criteria" here as the general requirements for substantial equivalence and safety for a wound dressing, and "reported device performance" as the outcomes of the tests conducted.
| Category | Acceptance Criteria (Implied / General Requirements for Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|---|
| Biocompatibility / Safety | Device must be safe for its intended use, demonstrating no unacceptable biological risks (cytotoxicity, sensitization, irritation, 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)." |
| "The studies indicated that Silverlon™ 1-Layer and 4-Layer Contact Wound Dressings are safe for their intended use." | ||
| Specific tests: cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study). | The device underwent and presumably passed all these specific tests. | |
| Functional Equivalence | Device characteristics (flexible primary contact wound dressing, permeability to oxygen and fluids, protection against microbial contamination of the dressing) must be comparable to predicate devices. | "The technological characteristics of the device... are substantially equivalent to the predicate devices cited." (Arglac, Acticoat, Tegapore) |
| Labeling / Intended Use Restrictions | No claims for use on third-degree burns, accelerating wound healing, long-term/permanent dressing, artificial skin, or as a treatment/cure for wounds. These would require further review. | The FDA letter (K981299) explicitly states these limitations. The 510(k) was accepted with these conditions on labeling. |
Missing Information (as per original request and not present in document):
- Specific quantitative acceptance criteria (e.g., "cytotoxicity index must be
N/A