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The NSK Precision Apex Locator is intended for the measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

The NSK Precision Apex Locator is a dental medical device which has the ability to measure the depth of the root canal by electronic means.

The provided text is a 510(k) Summary and the FDA's acceptance letter for the NSK Precision Apex Locator. It does not contain the detailed information needed to answer the questions regarding acceptance criteria and a specific study proving the device meets those criteria.

The 510(k) Summary (document {0}) outlines the device's intended use and claims substantial equivalence to a predicate device. It briefly mentions "testing results" as a basis for believing a difference in display technology does not raise additional safety or efficacy concerns, but it does not describe the specific acceptance criteria or the study methodology in detail.

The FDA letter (documents {1}, {2}, {3}) confirms the substantial equivalence determination but also does not provide the study details.

Therefore, I cannot provide the requested information based on the given text. The text does not elaborate on:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Whether a multi reader multi case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. Type of ground truth used for the test set.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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