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ImprEssix, Colorchange Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

ImprEssix, Colorchange Alginate is a dental impression material based on alginate.

The provided text is an FDA 510(k) clearance letter for the ImprEssix, Colorchange Alginate Impression Materials. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/machine learning device.

The questions posed (e.g., about multi-reader multi-case studies, standalone algorithm performance, training set size, etc.) are typical for the evaluation of AI or machine learning-based medical devices, which this product demonstrably is not. The ImprEssix material is a conventional dental impression material.

Therefore, I cannot answer the questions based on the provided text. To answer these questions, a document detailing the clinical validation or performance study of an AI/machine learning device would be required.

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ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, ImprEssix is particularly suited for orthodontics

ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour.

The provided text is an FDA 510(k) clearance letter for a medical device called "ImprEssix Alginate Impression Material." This letter is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics. Therefore, the detailed information requested in your prompt (acceptance criteria, specific study designs, sample sizes, expert qualifications, etc.) is typically not part of this type of regulatory document.

To directly answer your prompt based on the provided text, I must state that the information is not available within the document.

Here's a breakdown of why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not present. The letter mentions characteristics like "extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum," but these are descriptive features, not quantitative acceptance criteria with reported performance data from a study.
2. Sample size used for the test set and the data provenance: Not present. No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study details are provided.
4. Adjudication method for the test set: Not present. No study details are provided.
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: Not applicable. This device is an alginate impression material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an alginate impression material, not an algorithm.
7. The type of ground truth used: Not present. No study details are provided.
8. The sample size for the training set: Not applicable. This device is an alginate impression material, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This device is an alginate impression material, not a machine learning modelrequiring a training set.

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