(327 days)
SilverMed™ Antimicrobial Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
The Argentis SilverMedIM Antimicrobial Hydrogel is a moist hydrogel dressing designed to deliver antimicrobial silver that inhibits the growth of microbial contaminants. The high moisture content gel absorbs destructive components of wound exudate while promoting healthy tissue healing. Stabilizers prevent discoloration and staining from the dressing. The product is available in 1.5 oz and 3 oz containers.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SilverMed™ Antimicrobial Hydrogel:
This document is a 510(k) summary for a medical device seeking clearance, not a study report detailing clinical trial results or a comparative effectiveness study. Therefore, the information typically found in such a study for AI/software devices (like sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance) is largely not applicable or not present in this type of submission.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics, intended use, and performance data from in vitro and in vivo biocompatibility/antimicrobial tests.
Here's a breakdown of the requested information based on the provided text, with explanations where information is missing or not relevant to this type of regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO Modified Intracutaneous Study | Safe for contact with skin | Supports safe use in contact with breached or compromised skin. |
| ISO Intracutaneous Reactivity Test | Safe for contact with skin | Supports safe use in contact with breached or compromised skin. | |
| ISO Delayed Hypersensitivity Study | Safe for contact with skin | Supports safe use in contact with breached or compromised skin. | |
| Cytotoxicity | ISO Agar Diffusion (Direct) | Non-cytotoxic | Supports safe use in contact with breached or compromised skin. |
| Antimicrobial Efficacy | USP Antimicrobial Effectiveness Test | Inhibit microbial growth | Exceeds the requirements as set forth by the USP. |
| Substantial Equivalence | Comparisons to predicate devices (K011994, K062212, K061227, K071703, K932291) | Similar indications, technological properties, and performance | "Substantially equivalent" to predicate devices for indications of use, technological properties, and performance. |
2. Sample Sizes Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/software device evaluation. The studies referenced are in vitro and in vivo biocompatibility and antimicrobial efficacy tests.
- Sample Size: Not specified for individual biocompatibility or antimicrobial tests.
- Data Provenance: The studies are described as in vitro (Antimicrobial Effectiveness) and in vivo (Biocompatibility). The document does not specify country of origin for these tests. They are standard laboratory tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is typically relevant for evaluating the performance of diagnostic algorithms or imaging devices. For a hydrogel dressing, "ground truth" relates to objective measurements from laboratory and animal studies (biocompatibility, antimicrobial efficacy).
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers for diagnostic evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a hydrogel wound dressing, not an AI or diagnostic imaging system that would typically be evaluated with an MRMC study comparing human reader performance with and without AI assistance.
6. If a Standalone Performance Study Was Done
The device performance was evaluated through standalone in vitro and in vivo tests (biocompatibility and antimicrobial efficacy) as described, not "standalone performance" in the context of an AI algorithm without human-in-the-loop. The term "standalone performance" often refers to the algorithm's performance independent of human input, which isn't relevant here. The device's performance stands alone on its merit in safety and efficacy tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on objective measurements derived from standardized laboratory tests:
- Biocompatibility: Results from ISO Modified Intracutaneous study, ISO Intracutaneous Reactivity test, and ISO Delayed Hypersensitivity study. These tests define what is considered a safe biological response.
- Cytotoxicity: Results from ISO Agar Diffusion (Direct) test.
- Antimicrobial Efficacy: Results from the standard USP Antimicrobial Effectiveness Test . This test provides objective measurements of reduction in microbial contaminants.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" for this device as it is not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" or corresponding ground truth establishment methodology in the context of AI/machine learning for this device.
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