(198 days)
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.
Here's an analysis of the provided text to extract the requested information regarding the device's acceptance criteria and studies:
Assessment: The provided document is a 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing, specifically for a change in sterilization method from ETO to Gamma irradiation. It is primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, not with establishing novel performance characteristics through extensive clinical studies. Therefore, many of the typical performance study details for a new device are not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to existing COPA AMD antimicrobial wound dressings in: | The COPA AMD antimicrobial wound dressing is substantially equivalent to the existing COPA AMD antimicrobial wound dressings in intended use, materials, physical characteristics, and performance characteristics. |
| - Intended Use | Met |
| - Materials | Met |
| - Physical Characteristics | Met |
| - Performance Characteristics | Met |
| Change in sterilization method from ETO to Gamma irradiation | Not explicitly stated as "met" with specific criteria, but the 510(k) was cleared, implying the change was deemed acceptable and did not alter equivalence. The "Performance Data" section mentions "in-vitro testing" but doesn't detail specific acceptance criteria for this change. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses "in-vitro testing" to support the change in sterilization method. It does not provide details on:
- Sample size for a test set: No specific sample sizes for in-vitro tests are mentioned.
- Data provenance: No country of origin is specified for the in-vitro data.
- Retrospective or prospective: This is not applicable as it's in-vitro testing and not a human study.
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)
This is not applicable to this 510(k) submission. The submission focuses on demonstrating substantial equivalence through in-vitro testing related to a sterilization change, not on diagnostic performance where expert-established ground truth would be required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of a human-read test set or expert adjudication.
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
This is not applicable. The device is an antimicrobial wound dressing, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "in-vitro testing" mentioned, the ground truth would typically be established by standardized laboratory methods and analytical results, not by expert consensus, pathology, or outcomes data in the context of a clinical study. The document does not specify the exact nature of this "ground truth" but implies it's related to material properties, sterility, or antimicrobial effectiveness after gamma irradiation.
8. The sample size for the training set
This is not applicable. The device is a physical wound dressing and does not involve AI algorithms that require training sets.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
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