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510(k) Data Aggregation
(103 days)
TL TRISEB CREAM
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
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (TL Triseb Cream) |
|---|---|
| Safety: | |
| Non-primary irritant to human skin | Demonstrated to be a non-primary irritant (Met) |
| Non-primary sensitizer to human skin | Demonstrated to be a non-primary sensitizer (Met) |
| Not cytotoxic (in vitro) | Exhibited a slight reaction, meeting ISO 10993-5 and USP 23 requirements (Met) |
| Technological Characteristics (vs. Predicate): | |
| Similar Ingredients | Substantially similar, with minor differences (e.g., acifructol complex, vitis vinifera, glycyrrhetinic acid, and telmesteine absent in TL Triseb but present in Promiseb) |
| Similar Application per day | 2 to 3 times per day or as needed (Same as predicate) |
| Similar Indications for Use | Identical to predicate device |
| Similar Product Description | Identical to predicate device (off-white, steroid-free, fragrance-free, water-based emulsion) |
| Similar Physical Properties | Non-sterile, white cream; Viscosity 205,920 cps (Predicate: 228,800 cps); Consistency: smooth homogeneous; Microscopy: Uniform emulsion |
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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