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510(k) Data Aggregation
Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.
SILVERSEAL® Wound Packing Strip with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is 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.
The provided text is a 510(k) summary for the SILVERSEAL® Wound Packing Strips with X-Static®. This type of document is for clearance of a medical device, and therefore focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study with numerical thresholds.
As such, many of the requested categories for a rigorous study design (e.g., sample size for test set, number of experts, adjudication methods, multi-reader multi-case studies, effect size, training set details) are not applicable or not present in this type of submission. The primary "study" for a 510(k) is a comparison to a legally marketed predicate device.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission focused on substantial equivalence, there are no explicit numerical acceptance criteria described in the same way one might find in a clinical trial protocol (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied by demonstrating that the new device shares fundamental technological characteristics, intended use, and similar performance to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Design (Similar to predicates) | Flexible, non-adherent, protective dressing. Consists of nylon fibers with a metallic silver surface. |
| Performance (Similar to predicates) | Designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Silver provides effective protection of the dressing against microbial contamination. |
| Intended Use (Similar to predicates) | Control of local wound bleeding and nasal hemorrhage; encourages draining by wicking fluids from a body cavity, infected area, or abscess; helps remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing. |
| Biocompatibility (Safe for intended use) | Passed standard in vivo biocompatibility tests: cytotoxicity, sensitization, and acute intracutaneous reactivity. Performed in accordance with ISO 10993. |
| Technological Characteristics | Flexible primary contact wound dressing, permeability to oxygen and fluids, and protection against microbial contamination of the dressing. Substantially equivalent to cited predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. There was no specific "test set" of cases or patients in the sense of a clinical performance study with statistical endpoints. The evaluation was primarily based on material characterization and in vivo biocompatibility testing.
- Data Provenance: The biocompatibility tests were in vivo studies, likely conducted in animal models, but specific details on the "country of origin" or "retrospective/prospective" nature of patient data (which is not applicable here) are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There was no "ground truth" established by experts for a test set of clinical cases. The evaluation involved laboratory testing and comparison to existing device classifications and intended uses.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method was used, as there was no clinical test set requiring expert review or consensus.
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 packing strip, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" for the biocompatibility assessment was derived from standardized in vivo biological evaluations based on ISO 10993, rather than expert consensus, pathology, or outcomes data from human patients for performance claims.
- The "ground truth" for substantial equivalence relies on the established intended use, technological characteristics, and safety profile of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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