(381 days)
Under the supervision of a healthcare professional, Hylamix Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylamix Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Hylamix Cream is indicated for use in:
Atopic Dermatitis Allergic Contact Dermatitis Radiation Dermatitis
Non-sterile, white, fragrance free, topical cream. Hylamix forms a physical barrier which maintains a moist wound and skin environment, and will be marketed in a 100 g tube, and 450 g jar as a prescription device.
The provided text describes the 510(k) summary for Hylamix Cream, a medical device. It focuses on demonstrating substantial equivalence to a predicate device (Hylatopic Plus™ Cream) rather than establishing performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding a study proving device performance against acceptance criteria, particularly for an AI/algorithm-based device, is not present.
However, I can extract information related to the non-clinical and clinical performance studies conducted to confirm the safety and effectiveness of the Hylamix Cream.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria with corresponding performance metrics in a table format. Instead, it reports the results of safety tests.
| Test Type | Acceptance Standard (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity – Agar Diffusion (ISO 10993-5:2009) | Non-cytotoxic | Hylamix Cream proven to be Non-Cytotoxic. |
| Guinea Pig Sensitization | No sensitization reaction / Acceptable sensitization | The subject device elicited a sensitization reaction in guinea pigs. (Note: This indicates a positive reaction, which might not be an "acceptance," but is a reported finding). |
| Primary Dermal Irritation Tests (ISO 10993-10:2010) | No dermal irritation / Acceptable irritation | The subject device caused a slight dermal irritation response in rabbits. (Note: Similar to sensitization, this indicates a positive reaction). |
| Stability Studies (USP & USP) | Meets chemical and microbiological standards for shelf-life | 12-month expiration date in closed container; 9-month duration of use once opened. |
| 48 hours Patch Test on humans (Dermal Irritation) | Non-indicative of potential for dermal irritation | Hylamix Cream proven to be non-indicative to have a potential for dermal irritation. |
| Repeated Insult Patch Test (RIPT) on humans (Dermal Irritation & Allergic Contact Sensitization) | Non-indicative of potential for dermal irritation or allergic contact sensitization | Hylamix Cream proven to be non-indicative to have a potential for dermal irritation or allergic contact sensitization. |
2. Sample size used for the test set and the data provenance:
- Animal Studies:
- Guinea Pig Sensitization: Sample size not specified.
- Primary Dermal Irritation Tests in rabbits: Sample size not specified.
- Human Studies:
- 48 hours Patch Test on humans: Sample size not specified.
- Repeated Insult Patch Test (RIPT) on humans: Sample size not specified.
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, these studies would have been conducted by or for IGI Laboratories, Inc. The Declaration of Helsinki and 21 CFR parts 50 & 56 (related to human subject protection) are mentioned for the human studies, confirming ethical conduct requirements were followed. Whether these were retrospective or prospective is not specified, but typically pre-market studies are prospective.
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):
This information is not applicable as the studies described are for a topical cream, focusing on safety (cytotoxicity, sensitization, irritation) and stability, not diagnostic performance or image interpretation that would require expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the type of animal and human safety studies described.
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 information is not applicable. The device is a topical cream, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a topical cream, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For cytotoxicity, sensitization, and irritation tests: The "ground truth" would be the observed biological reactions (or lack thereof) in testing models, evaluated against established scientific and regulatory guidelines (e.g., ISO standards).
- For stability studies: The "ground truth" would be the measured chemical and microbiological properties over time, compared to pre-defined specifications.
- For human patch tests: The "ground truth" would be the clinical assessment of skin reactions by qualified personnel, adhering to ethical and scientific standards (Declaration of Helsinki, 21 CFR 50 & 56, ICH guideline E6).
8. The sample size for the training set:
This information is not applicable. The device is a topical cream; there is no "training set" in the context of an AI/algorithm-based device.
9. How the ground truth for the training set was established:
This information is not applicable. As above, there is no training set for this type of device.
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