(589 days)
Neosalus is indicated for management and relief of irritation associated with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
Neosalus is fragrance-free, water-soluble foam dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. Neosalus is intended for topical application.
This 510(k) summary for Neosalus does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Instead, it's a summary of the device's regulatory submission, focusing on establishing substantial equivalence to predicate devices (Mimyx Cream and Biafine Wound Dressing Emulsion).
Here's a breakdown of why the requested information cannot be provided based on the input:
- Acceptance Criteria and Reported Device Performance (Table): Not mentioned. The document primarily states that the product is a "fragrance-free, water-soluble foam dressing formulated for the management and relief of irritation experienced with various types of dermatoses." It doesn't quantify performance metrics, nor does it set specific thresholds for "relief of irritation."
- Sample Size for Test Set and Data Provenance: Not mentioned. No clinical studies or test sets are described. The "Performance Data" section simply states that predicate devices are "non-sterile formulations that are applied topically to relieve the symptoms of various dermatoses."
- Number of Experts and Qualifications: Not mentioned.
- Adjudication Method: Not applicable as no test set or expert review is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. No human reader studies are described.
- Standalone Performance Study: Not mentioned. The document focuses on the formulation and its intended use, rather than a quantifiable performance study.
- Type of Ground Truth Used: Not mentioned. Since no study is described, no ground truth types are relevant here.
- Sample Size for Training Set: Not applicable as this is not an AI/ML device and no training sets are mentioned.
- Ground Truth for Training Set: Not applicable.
Conclusion from the provided text:
The "Conclusions" section explicitly states: "Based on the 510(k) summaries (21CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the predicate devices under the Food Drug and Cosmetic Act." This indicates that the device was approved based on its similarity to existing, legally marketed devices, rather than a clinical study demonstrating performance against specific acceptance criteria.
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