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Under the supervision of a healthcare professional, Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Loutrex Topical Cream is a non-sterile, white to off-white water based emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.

The provided 510(k) application for Loutrex Topical Cream (K120730) does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about any clinical trials or performance testing.

The document is a submission for substantial equivalence to a predicate device, which focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing detailed performance study results against pre-defined acceptance criteria.

Here's a breakdown of what is and isn't in the document, based on your requested information:

What is mentioned:

• Intended Use: "Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process."
• Predicate Devices: Sinclair Skin Emulsion (cleared under K050158 and K111168, distributed by Promius Pharma, LLC as Promiseb® Topical Cream).
• General Statement on Testing: "Functional and performance testing has been conducted to assess the safety and efficacy of Loutrex Topical Cream and the results are satisfactory." (This is a generic statement and does not provide any specifics about the tests, acceptance criteria, or results.)

What is NOT mentioned (and therefore cannot be provided from this document):

• 1. A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or provide performance data for Loutrex Topical Cream.
• 2. Sample sized used for the test set and the data provenance: No information on sample size or data origin is provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set or expert-established ground truth.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 topical cream, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a topical cream, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable, as no model or algorithm is being developed or trained.
• 9. How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device for a topical cream. It explicitly states that "Functional and performance testing has been conducted to assess the safety and efficacy... and the results are satisfactory," but it does not provide any specific details about the nature of those tests, the acceptance criteria used, or the actual performance results. For a medical device like a topical cream, the "study" demonstrating safety and efficacy would typically involve clinical trials. However, the summary provided here does not include any data from such trials.

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