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The Apex DAL is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

The Apex DAL is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.

The provided text is a 510(k) summary and FDA clearance letter for a dental apex locator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and data provenance: No details regarding a test set, its sample size, or data origin are mentioned.
3. Number of experts used to establish ground truth and their qualifications: The document does not describe any ground truth establishment for a test set or the experts involved.
4. Adjudication method: No adjudication method is mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The text does not refer to any such study or human reader improvement with AI assistance.
6. Standalone performance study: While the device is "algorithm only" in the sense it measures electronically, no dedicated standalone performance study with specific metrics is detailed. The comparison focuses on technological characteristics rather than performance metrics against a gold standard.
7. Type of ground truth used: No ground truth type (e.g., pathology, outcomes data) is specified for any performance evaluation.
8. Sample size for the training set: There is no mention of a training set or its sample size.
9. How ground truth for the training set was established: Correspondingly, no information on ground truth establishment for a training set is provided.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, rather than detailed performance study results against specific acceptance criteria. It mentions that the manufacturer "believes this difference does [not] raise additional safety of efficacy concerns" based upon "testing results," but these results are not elaborated upon in the provided summary.

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