(262 days)
For over-the-counter use, SILVERSEAL® Adhesive Strips with X-Static® 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, SILVERSEAL® Adhesive Strips may be used for the management of: SILVERSEAL® Adhesive Strips with X-Static® 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).
SILVERSEAL® Adhesive Strips with X-Station 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 abainst microbial contamination. The nylon fabric permits the passage of exygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Adhesive Strips with X-Static; consists or a thin layer of approximately 22. metallic silver containing approximately 1.5 silver oxide that provides effective protection of the dressing against microbial contamination. SILVERSEAL: Adhesive Strips are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with 22% metallic silver surface containing approximately 1.58 silver oxide.
This 510(k) premarket notification for the SILVERSEAL® Adhesive Strip with X-Static® does not include acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic device would.
Instead, the submission focuses on substantial equivalence to existing predicate devices. The performance data provided are biocompatibility tests, which are standard for medical devices that come into contact with the body.
Here's an breakdown based on the information provided, highlighting why some sections of your request cannot be fully addressed:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for this type of device (biocompatibility) are generally qualitative (e.g., "safe," "non-sensitizing") rather than quantitative performance metrics like sensitivity/specificity for a diagnostic device. The document states all tests were performed in accordance with ISO 10993 and indicated safety.
| Feature / Test Category | Acceptance Criteria (Implied by ISO 10993) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity | Met (indicated safe) |
| No sensitization | Met (indicated safe) | |
| No acute intracutaneous reactivity | Met (indicated safe) |
Explanation of Device Performance:
- Biocompatibility: The device was subjected to standard in vivo biocompatibility tests, including cytotoxicity, sensitization, and acute intracutaneous reactivity.
- Results: All tests were performed in accordance with ISO 10993 (Biological Evaluation of Medical Devices) by Nittin American Science Associates, Inc. (NAMSA). The studies indicated that SILVERSEAL® Adhesive Strips with X-Station are safe for their intended use.
- Microbial Contamination Protection (of dressing): The silver and silver oxide in the dressing provide "effective protection of the dressing against microbial contamination." This claim is based on "In Vitro studies" and has not been studied in a clinical setting. This is a functional claim for the dressing itself, not a direct patient outcome claim.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Biocompatibility): Not specified in the provided document. Biocompatibility tests usually involve animal models (in vivo) or cell cultures (in vitro), with a specific number of subjects/samples depending on the ISO 10993 part being followed. The document only mentions "standard in vivo biocompatibility tests."
- Data Provenance: Not explicitly stated, but "Nittin American Science Associates, Inc. (NAMSA)" is a contract research organization (CRO) with a global presence, often performing tests in various locations.
- Retrospective or Prospective: Biocompatibility tests are typically prospective studies performed specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in this context. For biocompatibility testing, the "ground truth" is established by adherence to standardized protocols (ISO 10993) and established scientific methods, rather than expert consensus on complex diagnostic interpretations. The CRO (NAMSA) is implicitly qualified to perform these tests.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert image review or clinical outcome assessment in studies where human judgment is a primary input. Biocompatibility testing relies on objective, laboratory-based measurements and observations according to validated protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this device. These studies are typically performed for diagnostic imaging devices to evaluate how AI affects human reader performance.
6. If a Standalone Study Was Done
- Yes, in essence. The biocompatibility studies described are "standalone" in the sense that they evaluate the device's inherent safety properties without human intervention in the loop. The "In Vitro studies" for microbial protection are also standalone algorithm/device performance, though the details are not provided.
- "Algorithm only without human-in-the loop performance": This phrasing is more applicable to AI/software as a medical device. For a wound dressing, the "algorithm" is the physical/chemical properties of the dressing. Its performance (e.g., biocompatibility or antimicrobial action against the dressing itself) is assessed directly.
7. The Type of Ground Truth Used
- Biocompatibility: The "ground truth" is established by standardized biological responses observed in validated in vivo and in vitro models, as defined by ISO 10993. This is based on established scientific principles regarding material interaction with biological systems.
- Microbial Protection: The ground truth for the dressing's protection against microbial contamination is based on in vitro microbiological assays, which quantitatively measure microbial growth on the dressing material under controlled conditions. This is a form of laboratory-based evidence.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical wound dressing, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
In summary, the 510(k) submission for the SILVERSEAL® Adhesive Strip with X-Static® relies on demonstrating substantial equivalence to predicate devices and proving biocompatibility through standard in vivo tests. It also mentions in vitro studies for protection against microbial contamination of the dressing itself. The performance data presented are not in the context of diagnostic AI algorithms, so many of the requested categories (like sample size for test/training sets, expert ground truth, adjudication, or MRMC studies) are not directly applicable or available in the provided text.
N/A