(154 days)
TL-Cermide Skin Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. TL-Cermide Skin Emulsion helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
TL-Cermide Skin Emulsion is a steroid-free, fragrance-free, ceramide-dominant formulation
The provided 510(k) summary for TL-Cermide Skin Emulsion does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
This document is a premarket notification for a medical device (skin emulsion) and primarily focuses on demonstrating substantial equivalence to a predicate device already on the market (EPICERAM® Skin Barrier Emulsion cleared under K052643).
Here's a breakdown of why the requested information is not present and what the document does say:
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A table of acceptance criteria and the reported device performance: This information is not provided. The document states "Functional and performance testing has been conducted to assess the safety and efficacy of TL-Cermide Skin Emulsion and the results are satisfactory," but it does not detail what that testing was, what the acceptance criteria were, or what the specific performance results were.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No test set or ground truth establishment details are provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is mentioned.
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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: This is completely irrelevant for this type of device (a skin emulsion). MRMC studies, AI, and human readers are specific to diagnostic imaging or AI-assisted diagnostic devices, not topical medications.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As mentioned above, this is irrelevant for a skin emulsion.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information on ground truth.
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The sample size for the training set: Not applicable; this is not an AI or algorithm-based device that would have a training set.
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How the ground truth for the training set was established: Not applicable.
What the document does communicate regarding "proof" and "testing" is:
- Substantial Equivalence: The primary "proof" for this 510(k) submission is that the TL-Cermide Skin Emulsion is "substantially equivalent" to an already legally marketed predicate device (EPICERAM® Skin Barrier Emulsion). This means the FDA believes it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- "Satisfactory" Testing: The document vaguely states, "Functional and performance testing has been conducted to assess the safety and efficacy of TL-Cermide Skin Emulsion and the results are satisfactory." Without specific details, this statement indicates that some internal or external testing was done to support the safety and function of the emulsion, likely comparing its physical properties, stability, and possibly some basic biological effects (e.g., skin hydration, barrier function) to the predicate device or industry standards. However, the details of such testing, including specific criteria or results, are not included in this summary.
In summary, as per the provided text, there is no detailed information regarding acceptance criteria or specific study data to directly "prove" performance in the way one might expect for a diagnostic or AI-powered device. The regulatory pathway here relies on substantial equivalence to a previously cleared product and a general statement about satisfactory functional and performance testing.
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