Search Results

The NAVI ROOT is intended for measuring the length of the root canal for the purpose of performing root canals.

Not Found

This document is a marketing clearance letter from the FDA for the NAVI ROOT device, not a study report. Therefore, it does not contain the detailed information necessary to answer all the questions about acceptance criteria and study design.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used in pre-market testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.

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)
This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.

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
This information is not available in the provided document. The NAVI ROOT is described as a device for measuring root canal length, implying it's likely a primary measurement tool rather than an AI-assisted diagnostic aid for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Given NAVI ROOT is described as a device for "measuring the length of the root canal," it suggests a standalone measurement function. However, the exact details of standalone performance testing are not available in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available in the provided document. For a root canal length measurement device, ground truth would typically be established through highly accurate physical measurements or a gold-standard imaging technique.

8. The sample size for the training set
This information is not available in the provided document.

9. How the ground truth for the training set was established
This information is not available in the provided document.

Ask a specific question about this device