(124 days)
Advanced Wound Wash is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Elta Advanced Wound Wash). This type of document does not contain any information about acceptance criteria, study details, or performance metrics of the device in the way a clinical study report or a scientific publication would.
The FDA 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials for new performance claims.
Therefore, I cannot extract any of the requested information from the provided text, including:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, effect size: Not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical wound wash, not an algorithm.
- The type of ground truth used: Not applicable in this context.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document essentially states that the device is "substantially equivalent" to existing devices for its stated indications for use (removal of foreign material from dermal wounds). It does not provide any detailed performance data.
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