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For the management of open wounds.

Indications: For use as a wound dressing to manage pressure ulcers stages I-IV, stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions and skin irritations associated with periostomal care.

Amerigel™ Ointment Saturated Wound Dressing

This document is a 510(k) premarket notification letter from the FDA regarding a wound dressing device called Amerigel™ Ointment Saturated Wound Dressing. It determines the device is substantially equivalent to a previously marketed device. However, it does not contain information about acceptance criteria, study details, or performance metrics typically associated with proving a device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the device's main basis for clearance is its substantial equivalence to an existing predicate device, not necessarily a new clinical study demonstrating specific performance against predefined acceptance criteria.

Therefore, I cannot provide the requested information based on the text provided. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or its data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method for the test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory clearance letter, not a study report. It focuses on the legal and regulatory aspects of marketing the device based on substantial equivalence.

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