(122 days)
Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning, and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. Ceramax may be used to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Ceramax emollient formulation is a non-sterile, off-white, low odor, fragrance free, topical formulation delivers as a cream or a foam. The cream is dispensed via a tube and rubbed into the skin. When the Ceramax formulation is applied to diseased skin protective barrier that helps to maintain a moist wound and skin environment is formed. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
This document is a 510(k) Pre-market Notification for the Ceramax Skin Barrier Cream. It establishes substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, performance studies, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The document focuses on demonstrating that the new device is as safe and effective as existing ones.
Here's a breakdown of the information that can be extracted or deduced from the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
This section generally applies to studies demonstrating specific performance targets. For a 510(k) submission not involving new analytical or clinical performance claims, the "acceptance criteria" are primarily met through demonstrating equivalence to predicates in terms of intended use, technological characteristics, and safety/effectiveness.
| Acceptance Criteria Category | Ceramax Performance/Status |
|---|---|
| Performance Testing | Meets specification and performance characteristics for visual inspection, pH, viscosity, bioburden, and preservative effectiveness. |
| Biocompatibility | Meets applicable requirements of Blue Book Memorandum G95-1 (ISO-10993) and is biocompatible. |
| Safety and Effectiveness | Does not raise any new safety and efficacy concerns when compared to a similar legally marketed device. |
| Intended Use | Substantially equivalent to predicate devices (Epiceram K052643, TL-Cermide K110757) for relieving and managing burning/itching associated with various dermatoses. |
| **Technological | |
| Characteristics** | Substantially equivalent to predicate devices (e.g., non-sterile, cream formulation, tube delivery). |
Note: The document does not provide numerical or quantitative performance metrics against specific "acceptance criteria" for clinical efficacy beyond the statement of "substantially equivalent" intended use. The performance testing mentioned (visual inspection, pH, etc.) are quality control tests for the product's physical and chemical properties, not clinical efficacy.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in this context. The submission is not based on a new clinical study comparing Ceramax to a control or evaluating its performance on a test set of patient data for a diagnostic algorithm. It's a regulatory filing based on demonstrating equivalence to an existing product.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is not an AI or diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not mentioned or implied, as this is a topical skin barrier cream, not an imaging or diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a medical device (topical cream), not an algorithm or AI system.
7. The Type of Ground Truth Used
Not applicable in the conventional sense. The "ground truth" for this 510(k) submission is the regulatory status and established safety and effectiveness of the predicate devices (Epiceram K052643 and TL-Cermide K110757), to which Ceramax is demonstrating substantial equivalence. The claim is that Ceramax has the same intended use and similar technological characteristics, and therefore similar safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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