(394 days)
X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.
X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Laboratory antibacterial testing has demonstrated that 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 X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressing consists of a thin layer of metallic silver containing approximately 1.5% of 99% elemental silver that provides effective protection of the dressing against microbial contamination. Physical Description: 4 % x 4 % OD with a 2.5" x 2.0" square silver-colloid pad. The pad will consist of a colloid-film laminate, laminated to X-Static silver-plated nylon, number 90203.
The provided text describes the regulatory clearance of a medical device (X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings) rather than a study that establishes acceptance criteria and provides performance data against those criteria in the context of an AI/medical device performance evaluation. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to predicate devices, and subsequent FDA clearance.
Therefore, many of the specific questions regarding acceptance criteria, study design, expert involvement, and AI performance cannot be directly answered from the provided text.
However, based on the information available, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not present in the document. The document describes compliance with standard tests, but not specific numerical acceptance criteria (e.g., minimum sensitivity, specificity) and corresponding performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for quantitative performance metrics (e.g., accuracy, sensitivity, specificity). | Biocompatibility: Device met standards for cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation). |
| Antimicrobial Protection: Silver provides effective protection of the dressing against microbial contamination (demonstrated in laboratory antibacterial testing). |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "standard tests" and "in vitro studies" but does not specify sample sizes for these tests, nor does it detail data provenance (e.g., country of origin, retrospective/prospective). The studies are primarily laboratory-based for material properties and antimicrobial activity.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The studies mentioned are laboratory (in vitro) tests for biocompatibility and antimicrobial properties, not clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable. The studies are laboratory tests, not clinical evaluations requiring adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to existing predicate devices based on material properties, intended use, and general performance characteristics through laboratory testing, not a comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical dressing and not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the results of established laboratory methods for testing biocompatibility and antimicrobial properties.
- Biocompatibility: Defined by the outcomes of tests performed according to ISO 10993 standards (e.g., cytotoxicity, sensitization, systemic toxicity, tissue compatibility).
- Antimicrobial activity: Defined by the results of laboratory antibacterial testing demonstrating protection against microbial contamination.
8. The Sample Size for the Training Set
This question is not applicable as the device is a medical dressing and not an AI algorithm. There is no mention of a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as #8.
N/A