(425 days)
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, MimyX Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. MimyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
MimyX Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. MimyX Cream may also be used to soothe minor burns, including sunburn.
MimyX™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requires a physician diagnosis of disease state) and Over-the-Counter (OTC) use.
This document, a 510(k) Pre-Market Notification for MimyX™ Cream, describes a topical emulsion for managing and relieving symptoms of various dermatoses. However, it does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML-based medical devices.
Instead, this submission focuses on "substantial equivalence" to previously cleared devices (Biafine® Wound Dressing Emulsion and Sinclair Wound and Skin Emulsion), which is a common pathway for medical device clearance. The document states that "Functional and performance testing has been conducted to assess the safety and efficacy of MimyXTM Cream and results are satisfactory," but it does not provide the specifics of these tests or their results.
Therefore, for the information requested in your prompt, I can only provide an assessment based on the available text, with the understanding that many of the specific details you're looking for (e.g., sample sizes, expert qualifications, adjudication methods) are not present in this type of regulatory submission.
Here's an attempt to answer your questions based on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | "Functional and performance testing has been conducted to assess the safety... and results are satisfactory." |
| (Specific safety endpoints, metrics, or thresholds are not provided.) | |
| Efficacy: | "Functional and performance testing has been conducted to assess the... efficacy of MimyX™ Cream and results are satisfactory." |
| "Manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis." | (Specific efficacy endpoints, metrics, or thresholds are not provided.) |
| "Helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process." | (Specific efficacy endpoints, metrics, or thresholds are not provided.) |
| Comparison to Predicate Devices: "Substantially equivalent" to Biafine® Wound Dressing Emulsion (K964240) and Sinclair Wound and Skin Emulsion (K024367) in terms of being non-sterile topical emulsions that relieve symptoms of various dermatoses. | This is the primary "performance" claim: equivalence in mechanism and intended use. No quantitative performance metrics are provided for direct comparison. |
2. Sample size used for the test set and the data provenance
- Not Available. The document does not describe a clinical trial or a test set in the context of an AI/ML algorithm. It mentions "functional and performance testing" but provides no details on participant numbers, study design, or data origin (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Available. This information relates to the establishment of ground truth for a diagnostic or prognostic device, typically through expert review of data. MimyX™ Cream is a topical therapeutic emulsion, and the regulatory submission pathway (510(k) substantial equivalence) does not typically require this type of ground truth establishment.
4. Adjudication method for the test set
- Not Applicable/Not Available. As above, this concept doesn't apply to this type of device and submission.
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/Not Available. MimyX™ Cream is a product (cream), not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Available. This is not an AI/ML algorithm, so standalone performance is not relevant.
7. The type of ground truth used
- Not Available. For this type of product, "ground truth" might refer to established clinical endpoints (e.g., reduction in itching scores, improvement in skin barrier function, physician global assessment of dermatitis severity). However, the document does not specify what specific endpoints were measured or how their "truth" was established in the mentioned "functional and performance testing." The primary "truth" for this submission is that it is "substantially equivalent" to predicate devices already on the market for similar indications, implying comparable safety and efficacy profiles.
8. The sample size for the training set
- Not Applicable/Not Available. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set for an AI/ML algorithm exists for this product.
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