(129 days)
Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1ª and 2ª degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.
AcryDerm Antimicrobial Silver Gel Model #B is a repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds.
The provided text is a 510(k) summary for the AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B. This type of regulatory submission primarily focuses on establishing substantial equivalence to a predicate device rather than demonstrating performance against specific, quantitative acceptance criteria through clinical or complex technical studies as would be seen for AI/ML devices or novel diagnostic tools.
Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this document. The device is a wound dressing, and the assessment centers on safety, biocompatibility, and manufacturing practices, not on diagnostic performance or AI model evaluation.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Biocompatibility | Meets or exceeds safety and biocompatibility assurance guidelines as provided in Part-1 of the ISO standard (Biological Evaluation of Medical Devices) and NIH Publication 99-4494. |
| Preservative Assurance | Meets or exceeds USP Preservative Assurance Testing requirements for a repeat use product. |
| Manufacturing | Will be manufactured according to product specifications and in accordance with good manufacturing practices to ensure the device is safe and effective for its intended uses. |
| Performance Standards (FDA) | No performance standards are prescribed for the new product. |
| Substantial Equivalence | Determined to be substantially equivalent to legally marketed predicate devices (AcryDerm Silver Antimicrobial Wound Gel and AcryDerm Silver Antimicrobial OTC Wound Gel). |
Study Information (as applicable to this type of device)
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Sample size used for the test set and the data provenance: Not applicable. The testing described (safety, biocompatibility, preservative assurance) would not typically involve a "test set" or "data provenance" in the way it's understood for AI/ML or diagnostic device studies. These are laboratory-based tests on the device materials themselves or microbiological performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as expert consensus is not a concept relevant to the testing methods for this wound dressing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No 'adjudication' in this sense would be used for the device's stated testing.
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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 dressing, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests mentioned are:
- Safety and Biocompatibility: Conformance to established ISO and NIH standards (pre-defined thresholds for toxicological and biological responses).
- Preservative Assurance: Conformance to USP standards (pre-defined microbial reduction and stability criteria).
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The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of medical device assessment.
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How the ground truth for the training set was established: Not applicable, as there is no training set.
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