(91 days)
For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
SILVERSEAL® Burn Contact Wound Dressings with X-Static® 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 SILVERSEAL® Contact Wound Dressings with X-Static® consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination.
SILVERSEAL® Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SILVERSEAL® Burn Glove with X-Static® and related dressings:
No acceptance criteria or study demonstrating performance against such criteria are explicitly provided in this 510(k) summary.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and biocompatibility.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does NOT explicitly state any acceptance criteria for device performance (e.g., specific percentages for infection reduction, healing rates, or other clinical outcomes).
Instead, the "performance" discussed is related to biocompatibility and protection against microbial contamination of the dressing itself.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| N/A (No specific numerical acceptance criteria for clinical efficacy are provided.) | - Biocompatibility: Passed standard in vivo tests (cytotoxicity, sensitization, acute intracutaneous reactivity) in accordance with ISO 10993. |
- Protection Against Microbial Contamination (of the dressing): The silver content provides effective protection of the dressing against microbial contamination (based on in vitro studies). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set for Biocompatibility: The sample size for the in vivo biocompatibility tests (cytotoxicity, sensitization, acute intracutaneous reactivity) is not specified.
- Data Provenance: The biocompatibility tests were performed by North American Science Associates, Inc. (NAMSA), which is a common contract research organization for medical device testing. The country of origin for the data is implicitly the USA, where NAMSA operates. These tests are typically prospective in nature, conducted specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable.
- For biocompatibility tests, "ground truth" is typically established by laboratory standards and protocols (e.g., observing for specific cellular reactions, skin reactions) rather than expert consensus on a clinical outcome.
- There is no mention of a human-centric "test set" requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable.
As there is no "test set" requiring human interpretation or clinical judgment in the traditional sense for efficacy or diagnostic performance, no adjudication method is mentioned. Biocompatibility results are typically objective measurements or observations against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done.
The document explicitly states: "All claims are the result of In Vitro studies and have not been studied in a clinical setting." This confirms that no clinical studies comparing the device's effectiveness, either with or without AI assistance, were performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable, and no such study was performed.
This is a medical dressing, not an algorithm or AI device. Therefore, the concept of "standalone algorithm performance" does not apply. The performance evaluation was focused on materials, biocompatibility, and antimicrobial properties of the dressing itself.
7. The Type of Ground Truth Used
- Biocompatibility: The "ground truth" for biocompatibility was established through performance against standardized laboratory protocols and observations for cytotoxicity, sensitization, and acute intracutaneous reactivity, as defined by ISO 10993.
- Antimicrobial properties (of the dressing): The "ground truth" for protection against microbial contamination of the dressing was established through in vitro studies, which involve lab-based testing of the material's ability to inhibit microbial growth.
8. The Sample Size for the Training Set
Not applicable.
This product is a medical dressing, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
As there is no AI algorithm or "training set," there is no ground truth established in this context.
N/A