Search Results

NEOSALUS Cream is indicated for management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.

NEOSALUS Cream is fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application.

The provided text describes NEOSALUS Cream, which is a non-sterile formulation intended for topical application to manage various types of dermatoses, including atopic dermatitis and allergic contact dermatitis. This submission is a 510(k) premarket notification claiming substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific quantitative acceptance criteria or a detailed performance study with reported metrics for NEOSALUS Cream. The claim of substantial equivalence is based on the new device being a modified version of an already approved predicate device.

Instead, the submission states:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not mention any specific sample sizes for a test set. This type of 510(k) submission for a cream/drug product often relies on chemical formulation comparisons and intended use similarity to a predicate, rather than a clinical performance study with a test set. There is no information on data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as no clinical or performance test set, requiring expert-established ground truth, is described. The approval is based on substantial equivalence to a predicate, not on a novel performance claim that would necessitate such expert evaluation.

4. Adjudication Method for the Test Set:

This information is not applicable as no specific test set requiring adjudication is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices or diagnostic algorithms where human readers' performance is compared with and without AI assistance. This submission is for a topical cream, which does not involve such an evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

No, a standalone performance study was not done. This concept is relevant for artificial intelligence algorithms. NEOSALUS Cream is a topical medication and does not involve an algorithm.

7. The Type of Ground Truth Used:

No specific ground truth (expert consensus, pathology, outcomes data, etc.) was explicitly stated as being used for performance evaluation because a clinical performance study with a test set is not detailed. The basis for approval is substantial equivalence to the predicate device in terms of formulation and intended use.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is a pharmaceutical cream, not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. As there is no training set mentioned, there is no ground truth establishment process for it.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria, in this context, is the demonstration of substantial equivalence to an already legally marketed predicate device (NEOSALUS, K070309) under the Food, Drug, and Cosmetic Act. The acceptance criteria essentially revolve around the new device having the same intended use and similar technological characteristics (e.g., being a non-sterile, topically applied formulation for dermatoses) as the predicate device, leading to a conclusion of safety and effectiveness without the need for new, extensive clinical trials. The provided document serves as the "summary" of how this equivalence was established.

Ask a specific question about this device