(147 days)
Rx: Nivatopic™ Plus 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. Nivatopic™ Plus also helps relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Nivatopic Plus is a non-sterile, steroid free, semi-viscous emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.
The provided text describes a 510(k) application for a device called Nivatopic™ Plus, which is a non-sterile, steroid-free, semi-viscous emulsion intended for topical application to manage and relieve symptoms of various dermatoses.
However, the documentation does not contain information regarding acceptance criteria, a specific study proving device performance against acceptance criteria, or details about a clinical study involving human readers or standalone algorithm performance. The 510(k) summary only states that "Functional and performance testing has been conducted to assess the safety and efficacy of Nivatopic™ Plus and the results are satisfactory."
The 510(k) clearance process primarily establishes substantial equivalence to a predicate device, rather than requiring extensive clinical trials or performance metrics of the kind typically associated with AI/software devices. The predicates mentioned are other topical emulsions (Hylatopic Plus™ Cream and HPR™ Plus Emollient Foam). The safety evaluation is stated to meet USP and ISO requirements.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "Functional and performance testing has been conducted to assess the safety and efficacy of Nivatopic™ Plus and the results are satisfactory." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified.
- Data provenance: Not specified (no clinical study details are provided).
- Retrospective or prospective: Not specified.
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)
- Not applicable/Not specified as no clinical study with expert ground truth establishment is described for this 510(k). The evaluation relies on substantial equivalence to predicate devices and general functional/performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. This device is a topical emulsion, not an AI/software device that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is a medical device (topical emulsion), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified. The 510(k) process for this type of device relies on demonstrating substantial equivalence in terms of safety, technological characteristics, and intended use, often supported by bench testing and adherence to standards (USP, ISO), rather than clinical ground truth as understood in diagnostic studies.
8. The sample size for the training set
- Not applicable/Not specified, as this is a physical medical device (topical emulsion), not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified, for the same reason as above.
In summary, the provided document is a 510(k) premarket notification for a topical dermatological product. It focuses on demonstrating substantial equivalence to already marketed predicate devices and mentions that functional and performance testing for safety and efficacy has been conducted. It does not contain the specific details about acceptance criteria, clinical study designs, ground truth establishment, or sample sizes for test/training sets that would be expected for a diagnostic or AI-based device.
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