(342 days)
The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and fungal penetration. The barrier function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds. It has not been evaluated in third degree burns.
Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-density polyethylene (HDPE) mesh. The sustained release of silver actively protects the wound site from bacterial and fungal contamination. The dressing will be sold in a variety of sizes.
The provided text does not describe a study to prove the device meets acceptance criteria in the traditional sense of a clinical trial with specific performance metrics. Instead, it is a 510(k) submission summary for the ACTICOAT® Primary Antimicrobial Dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against predefined acceptance criteria through a specific study.
The primary "acceptance criterion" in a 510(k) submission is the demonstration of substantial equivalence to a legally marketed predicate device. This is achieved by comparing the new device's intended use, technological characteristics (design, materials), and safety/effectiveness data to those of the predicate.
Here's how to address the questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
As mentioned, there are no explicit "acceptance criteria" and "reported device performance" in the context of a prospective study for this specific 510(k) submission. The document's closest equivalent is a comparison for substantial equivalence.
| Acceptance Criterion (for 510(k) Equivalence) | Reported Device Performance / Characteristics |
|---|---|
| Intended Use (Wound Dressing) | Yes (Matches predicate) |
| Design: HDPE Skin Contact Layer | Yes (Matches predicate) |
| Design: Absorbable | No (Differs from one predicate, matches another) |
| Design: Antimicrobial silver coating | Yes (Present, distinguishes it from one predicate) |
| Materials (HDPE & Polyurethane backing) | HDPE (Matches predicate) |
| Biocompatibility | Demonstrated through in vivo and in vitro tests |
| Safety and Effectiveness | Substantially equivalent (based on comparison and biocompatibility) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable (N/A). The document does not describe a "test set" in the context of a clinical performance study. The "in vitro testing" mentioned is for antimicrobial effectiveness and biocompatibility, not for assessing wound healing performance against a specific set of test cases.
- Data Provenance: N/A for a clinical performance test set. The biocompatibility and antimicrobial effectiveness data would likely be from laboratory studies, but the document does not specify their origin or whether they were retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. There is no mention of a test set with an established ground truth by experts in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring adjudication is described.
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
- N/A. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A for clinical performance. For the antimicrobial claim, the "ground truth" would be established by in vitro microbiological testing (e.g., zone of inhibition, bacterial kill rates) against known pathogenic microorganisms, as stated by "based on in vitro testing. Data on file." This type of ground truth is laboratory-based and uses established microbiological assay methods.
- For biocompatibility, the ground truth is established through standard in vivo and in vitro toxicology tests (e.g., cytotoxicity, irritation, sensitization), as mentioned.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. This is not an AI/machine learning device.
Summary of the document's approach:
The ACTICOAT® Primary Antimicrobial Dressing's 510(k) submission relies on:
- Substantial Equivalence: Comparing its intended use and technological characteristics to legally marketed predicate devices (ACTICOAT® Composite dressing and N'Terface dressing). The key difference highlighted is the antimicrobial silver coating, which is also present in one of the predicate devices.
- In vitro testing: To support the antimicrobial claims ("effective barrier to bacterial and fungal penetration") and biocompatibility.
- Previous testing on individual components: For biocompatibility, leveraging existing data for its constituent materials.
The document does not describe a new clinical study to evaluate the device's performance against specific acceptance criteria for wound healing outcomes in humans. Its clearance is based on its similarity to existing devices and positive laboratory findings.
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