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

TL Triseb cream is a non-sterile viscous emulsion/cream formulation. TL Triseb Cream is an off-white, steroid-free, fragrance-free, water-based emulsion.

This 510(k) application for TL Triseb Cream asserts substantial equivalence to a predicate device (Promiseb® Topical Cream) rather than establishing de novo acceptance criteria for the device's performance. Therefore, the information provided does not contain a typical study outlining acceptance criteria, a test set, ground truth, or details on human reader performance, as would be expected for a diagnostic or AI-driven medical device.

Instead, the submission focuses on demonstrating that the new device shares similar technological characteristics and has comparable safety and performance to the already-cleared predicate device.

However, based on the provided text, we can infer some 'acceptance criteria' in terms of safety and the studies conducted to support them.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific questions:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Safety Tests:
  • Repeat Insult Patch Testing: 50 human subjects. The provenance (country of origin) and whether it was retrospective or prospective are not specified, but this type of testing is generally prospective.
  • L929 Agar Overlay Cytotoxicity study: This is an in-vitro study (cell culture), so "human subjects" or "country of origin" are not applicable in the same way. The sample size refers to the cells tested, not specified beyond "cells."
• Technological Comparison: This involved a direct comparison of product specifications and characteristics, not a human subject test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as the studies cited are for safety (irritation, sensitization, cytotoxicity) and material comparison, not for diagnostic performance requiring expert consensus on a 'ground truth' for a specific disease outcome. The 'truth' for the patch test is the observed skin reaction, and for cytotoxicity, it's the cellular response to the extract.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation of medical data. The safety tests performed (patch test, cytotoxicity) do not involve such a process.

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

• No. This type of study (MRMC, AI assistance) is not relevant to this device, which is a topical cream for seborrheic dermatitis, not a diagnostic imaging or AI-driven tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. Again, this is for an AI/algorithm-based device, which TL Triseb Cream is not.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the Repeat Insult Patch Testing, the "ground truth" is the observed dermal reaction (e.g., erythema, edema) on the human subjects, typically assessed by a qualified dermatologist or allergist following a standardized protocol.
• For the L929 Agar Overlay Cytotoxicity study, the "ground truth" is the cellular response (viability, morphology) observed under a microscope, measured against control cells, as per ISO 10993-5 and USP 23 guidelines.
• For the Technological Characteristics Comparison, the "ground truth" is the verified specifications of both the proposed device and the predicate.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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AVO Cream Topical Emulsion is indicated for use in:

• Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers ●
• Superficial wounds
• 1st and 2nd degree burns, including sunburns .
• Dermal donor and graft site management .
• Radiation dermatitis .
• Minor abrasions .

AVO Cream Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream Topical Emulsion provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.

The provided text is a 510(k) summary for AVO Cream Topical Emulsion, a wound dressing. It declares substantial equivalence to a predicate device and states that functional and performance testing was conducted to assess safety and efficacy with satisfactory results. However, the document does not contain explicit acceptance criteria, detailed study designs, or reported device performance metrics that would allow for the completion of the requested table and answers to points 2 through 9.

Here's an analysis of what can be extracted and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

Explanation: The document states, "Functional and performance testing has been conducted to assess the safety and efficacy of AVO Cream Topical Emulsion and the results are satisfactory." This is a general statement and does not provide specific acceptance criteria (e.g., "wound healing time reduced by X%") or quantitative performance data to fill this table.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not provided.
• Data provenance: Not provided. The document focuses on regulatory submission and substantial equivalence rather than a detailed study protocol or results.

3. 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)

• Not applicable/Not provided. The document does not describe studies involving expert-established ground truth for a test set. The assessment of "safety and efficacy" would typically involve clinical or pre-clinical studies, but the details are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

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 is a medical device (topical emulsion) and not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a medical device (topical emulsion) and not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated. Given it's a wound dressing, "outcomes data" related to wound healing, safety (e.g., adverse events), and patient comfort would be expected, but the document does not specify what type of data served as "ground truth" for their internal "functional and performance testing."

8. The sample size for the training set

• Not applicable/Not provided. This document implies pre-clinical and possibly clinical testing for safety and efficacy, not a "training set" for an algorithm.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

In summary: The provided 510(k) summary is a regulatory document affirming substantial equivalence to an existing device (Biafine® Wound Dressing Emulsion, K964240). It states that functional and performance testing was performed with satisfactory results but does not include the detailed study information, acceptance criteria, or performance metrics requested. This level of detail is typically found in the full submission, not the summary intended for public disclosure.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is mentioned.

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: 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.

6. 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information on ground truth.

8. The sample size for the training set: Not applicable; this is not an AI or algorithm-based device that would have a training set.

9. 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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