(381 days)
Under the supervision of a healthcare professional, Dash-Topic Plus 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. Dash-Topic Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Dash-Topic Plus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. Dash-Topic Plus Cream forms a physical barrier that helps to maintain a moist wound and skin environment. Dash-Topic Plus Cream is a prescription device.
The provided document is a 510(k) summary for the medical device "Dash-Topic Plus Cream." It is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to a legally marketed predicate device. This type of document focuses on comparing the new device to an existing one, rather than presenting a study of its independent effectiveness against clinical outcomes or a rigorous clinical trial. Therefore, the document does not contain the information required to answer your specific questions about acceptance criteria, detailed study designs, sample sizes, expert ground truth, or comparative effectiveness with human readers.
The document discusses "Performance Data" but this refers to non-clinical testing (biocompatibility, stability, etc.) to ensure safety and functionality, not clinical performance in terms of diagnostic accuracy or impact on human readers.
Here's a breakdown of what can be extracted and why the other information is missing:
1. A table of acceptance criteria and the reported device performance
- Missing from document: The document does not provide a table of acceptance criteria in terms of clinical efficacy or diagnostic performance. The "performance data" section (Section VIII) lists non-clinical tests (biocompatibility, stability) and states the results (e.g., "non-cytotoxic, a negligible irritant and non-sensitizing"), but it doesn't define acceptance criteria for these tests within the narrative. Their acceptance is implied by the "Conclusion" that the device is substantially equivalent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from document: There is no clinical test set described in the sense of a patient cohort or diagnostic images. The "tests" mentioned are laboratory-based assays (e.g., Agar Diffusion Cytotoxicity). Sample sizes for these types of tests typically refer to the number of samples or replicates tested in the lab, not patient populations. No data provenance in terms of country of origin or retrospective/prospective nature is applicable as no clinical study is described.
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)
- Missing from document: Not applicable. No clinical ground truth or expert review is mentioned because no clinical study or diagnostic AI algorithm testing is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from document: Not applicable. No clinical adjudication method is mentioned as there is no clinical test set to adjudicate.
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
- Missing from document: Not applicable. This document pertains to a topical cream, not an AI-powered diagnostic device, and therefore no MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from document: Not applicable. This device is a topical cream, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing from document: Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be the established scientific standards and methods for assessing cytotoxicity, irritation, sensitization, and stability (e.g., ISO standards, USP monographs).
8. The sample size for the training set
- Missing from document: Not applicable. This document is for a medical device (topical cream), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Missing from document: Not applicable. As above, there is no AI algorithm or training set.
Summary of what the document does provide regarding "performance":
The "Performance Data" (Section VIII) describes non-clinical testing to confirm the safety and effective performance in terms of the cream's physical and biological interaction with the body (biocompatibility) and its stability.
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Tests Conducted:
- Agar Diffusion Cytotoxicity (ISO 10993-5: 2009)
- Direct Primary Skin Irritation (ISO 10993-10:2010)
- Kligman Maximization Sensitization (ISO 10993-10:2010)
- Bench performance testing for release and shelf life stability (monitored parameters: Appearance, pH, preservative content, viscosity and package integrity)
- Preservative Effectiveness Testing as per USP (Antimicrobial Effectiveness Testing)
- USP (Microbial Enumeration Tests and Tests for Specified Microorganisms)
- In-use stability testing for opened 450g container (monitored parameters: Appearance, pH, preservative content, viscosity, package integrity, USP and USP )
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Reported Results (Performance):
- Dash-Topic Plus Cream is non-cytotoxic.
- Dash-Topic Plus Cream is a negligible irritant.
- Dash-Topic Plus Cream is non-sensitizing.
- The bench performance data confirmed the physical characteristics, stability, and shelf-life.
The acceptance criteria for these tests are implicitly that the device passes specific thresholds or shows no adverse effects according to the referenced ISO and USP standards. However, the exact numerical acceptance criteria are not explicitly stated in this summary.
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