(482 days)
Under the supervision of a healthcare professional, NUTRASEB Facial Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. NUTRASEB Facial Cream helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
NUTRASEB Facial Cream is a non-sterile, steroid-free, fragrance-free, water-based emulsion for the management of the signs and symptoms of seborrheic dermatitis which is presented for prescription use. NUTRASEB Facial cream is supplied in a polyethylene tube. Two 50 gram polyethylene tubes will be packaged together within a single carton.
This document describes the regulatory approval for a topical cream, not a medical device that uses AI or goes through extensive clinical trials for performance beyond safety and substantial equivalence to a predicate device. Therefore, many of the requested details about acceptance criteria, study methodologies for AI/imaging devices, expert involvement, and ground truth establishment are not applicable.
However, I can extract the relevant information from the provided document regarding the product's performance and the basis for its approval.
Here's an interpretation based on the provided text:
The document is a 510(k) Premarket Notification from the FDA regarding the "NUTRASEB Facial Cream". This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device's efficacy through extensive clinical performance studies. Performance data in this context is primarily related to safety and confirming the new device's similarity to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a topical cream, the "acceptance criteria" are not related to diagnostic accuracy or AI performance metrics. Instead, they pertain to safety and equivalence to the predicate.
| Acceptance Criteria (Implied for 510(k) equivalence) | Reported Device Performance (NUTRASEB Facial Cream) |
|---|---|
| Safety: Non-toxic, non-irritating, non-sensitizing | Cytotoxicity: Not cytotoxic (Agar diffusion; ISO 10993-5:2009) |
| Dermal Irritation: "Slightly irritant" in rabbits | |
| Sensitization Potential: Mildly sensitizing in guinea pigs | |
| Toxicological Analysis: Safety corroborated by toxicological analysis of components | |
| Clinical Safety: Rare reports of skin sensitivity; does not appear to induce phototoxicity or photoallergy reaction | |
| Stability: Chemical and microbiological stability over time | Expiration Date: 36 months (closed container), 6 months (after opening) per USP |
| Equivalence to Predicate: Similar indications for use, design, and materials | Indications for Use: Matches predicate (Promiseb® Topical Cream) for managing seborrhea/seborrheic dermatitis signs/symptoms, maintaining moist skin for healing. |
| Design & Materials: Contains similar emollients, humectants, skin conditioning agents, piroctone olamine, and ascorbyl palmitate; non-sterile, water-based emulsion, topical application. |
Note: The FDA's determination of substantial equivalence means they believe it is as safe and effective as the predicate device. The "slightly irritant" and "mildly sensitizing" results were acceptable in the context of it being a topical cream for managing a skin condition and balanced against the toxicological analysis and clinical safety observations.
2. Sample Size and Data Provenance
- Non-clinical testing:
- Dermal Irritation: Tested in "rabbits" (specific number not given, but typically a small group for this type of test).
- Sensitization Potential: Tested in "guinea pigs" (specific number not given, but typically a small group).
- Cytotoxicity (in vitro): Not applicable to animal or human sample size.
- Clinical Performance: "Several clinical tests were conducted," but no specific sample sizes for these tests are provided. The "rare reports of skin sensitivity" suggest this might be based on post-market surveillance data or cumulative safety data from various tests, rather than a single, large-scale controlled clinical trial with a defined sample size for efficacy.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The context suggests studies were done to support regulatory filing, likely by or for the manufacturer. It's safe to assume these were prospective safety tests conducted specifically for this submission, rather than retrospective analysis of patient data.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This is not a diagnostic device where expert readers determine ground truth for imaging. The "ground truth" for this product is its chemical properties, biological interactions (safety endpoints), and its ability to relieve symptoms as observed in clinical (safety) studies, which is subjectively reported or objectively measured (e.g., erythema reduction). The experts involved would be toxicologists, dermatologists, and chemists involved in the product's development and safety assessment.
4. Adjudication Method for the Test Set
- Not applicable. There's no "test set" in the sense of a set of cases requiring expert review and adjudication for AI performance. Safety data is collected and analyzed by scientific experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is specifically for diagnostic imaging devices, often AI-assisted, to compare human reader performance with and without AI assistance. It is not relevant for a topical cream.
6. Standalone Performance (Algorithm Only)
- No. This is a topical cream, not an algorithm or an AI device.
7. Type of Ground Truth Used
- The "ground truth" for this product's approval is based on:
- Biocompatibility/Safety assays: In-vitro cytotoxicity tests, in-vivo animal irritation and sensitization studies.
- Chemical and Microbiological Stability Data: Laboratory tests confirming the product's shelf life.
- Toxicological Analysis of components.
- Clinical Safety Observations: Reports of skin sensitivity, phototoxicity, and photoallergy reactions, likely from small human safety studies or post-market data.
- Comparison to Predicate Device: The main "ground truth" for a 510(k) is demonstrating that the new device is substantially equivalent to a device already legally marketed for the same intended use.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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