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Curative Dental Acrylic Teeth are preformed plastic denture teeth intended for use as teeth in dentures.

Curative Dental Acrylic Teeth are preformed plastic denture teeth.

The provided text describes the 510(k) premarket notification for "Curative Dental Acrylic Teeth." It states that "Data were provided to demonstrate that the Curative Dental Acrylic Teeth comply with applicable safety and performance standards." However, the document does not include specific acceptance criteria, detailed study designs, or performance results. It focuses on the regulatory submission and FDA's determination of substantial equivalence to predicate devices based on the same or similar materials and intended use.

Therefore, I cannot provide accurate information for most of your requested points based only on the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states "Data were provided to demonstrate... compliance," but it does not specify what those data were, what the acceptance criteria were, or the actual performance results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The text does not mention any sample sizes for testing or the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Cannot be provided. This type of information is not relevant to a device like dental acrylic teeth, which do not typically require expert interpretation of images or other subjective data to establish a "ground truth" in the way an AI diagnostic device would.

4. Adjudication method for the test set

• Cannot be provided. As above, this is not applicable for this type of device and study.

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

• Cannot be provided. This is explicitly an AI-related study type and is not relevant to "Curative Dental Acrylic Teeth."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Cannot be provided. This is an AI-related study type and is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. For this type of product, "ground truth" would likely refer to established material properties and functional tests rather than clinical outcomes or pathology. However, the document does not specify these.

8. The sample size for the training set

• Cannot be provided. This is an AI-related term and is not relevant to a traditional medical device like dental acrylic teeth.

9. How the ground truth for the training set was established

• Cannot be provided. This is an AI-related term and is not relevant.

In summary, the provided document is a regulatory approval letter for a medical device (dental acrylic teeth), not a scientific study detailing performance criteria and results in the way one would find for a diagnostic or AI-powered device. It indicates that some performance data were submitted to the FDA to demonstrate compliance with standards, leading to a determination of substantial equivalence, but it does not disclose the specifics of those data or the studies themselves.

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