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510(k) Data Aggregation
(187 days)
COPA AMD ANTIMICROBIAL WOUND DRESSING
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 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.
The provided text from the 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing describes performance data related to its antimicrobial properties. The information pertains to the device's ability to prevent bacterial penetration and colonization.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Broad-spectrum antimicrobial activity against specified organisms | Demonstrated broad-spectrum activity against 6 organisms (gram-positive, gram-negative, and fungal types). |
| Effectiveness over time against bacterial challenge | Total kill was achieved for 7 consecutive days, with a daily challenge of >6 log of each organism. |
| Target organisms | P. aeruginosa, E. coli, C. albicans, S. epidermidis, S. aureus, E. faecalis. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in terms of the number of unique dressings or tests. The tests were performed in-vitro and an animal testing was also mentioned.
- Data provenance: The tests were described as "in-vitro and animal testing," indicating laboratory and possibly animal model experiments. The country of origin for these tests is not specified, but the submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance data is based on laboratory (in-vitro) and animal testing, which typically relies on established microbiological and scientific protocols rather than expert consensus on subjective observations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is relevant for studies involving human interpretation (e.g., image reading), not for laboratory or animal testing results.
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
Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established through microbiological assays (quantifying bacterial kill) for the in-vitro tests and likely biological endpoints related to infection or wound healing for the animal testing.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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