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Elta Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Elta Wound Cleanser." It states that the device is substantially equivalent to legally marketed predicate devices. The document also includes the "Indications for Use" for the device.

However, the text does not contain any information about:

• Acceptance criteria or reported device performance
• Details of any study (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set) that would prove the device meets acceptance criteria.

The letter is a regulatory approval document and not a scientific study report. Therefore, I cannot fulfill your request for the specific details of a study and acceptance criteria based solely on the provided text.

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Advanced Wound Wash is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

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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:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, effect size: Not present.
6. 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.
7. The type of ground truth used: Not applicable in this context.
8. The sample size for the training set: Not applicable.
9. 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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Elta Silver Antimicrobial Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

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This document is a letter from the FDA regarding the 510(k) premarket notification for the "Elta Silver Antimicrobial Wound Gel". It states that the device is substantially equivalent to legally marketed predicate devices.

The information you are asking for, regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, and comparative effectiveness studies, is typically found in the premarket notification submission itself, which is a much more detailed document than this FDA clearance letter. This letter is simply the FDA's decision based on their review of that submission.

Therefore, this document does not contain the information requested in your prompt. It does not describe acceptance criteria, device performance, details of studies, sample sizes, or ground truth methodologies. It only states that the device has been found substantially equivalent for the indicated uses.

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