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An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

The Cleartooth Digital X-Ray System software processes standard dental images captured from a sensor device that is placed in a patient's mouth as if it were dental X-ray film. It provides users with a familiar personal computer moveable window interface, including pushbuttons, tool bars, pull-down menus, and pop-up menus. It allows users to access its features by point and click, and it allows them to work with images using intuitive and responsive features like orienting an image.

This device, the Cleartooth Digital X-Ray System, is a Class II medical device that produces digital radiographs intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and supporting oral structures.

Based on the provided information, the submission describes a substantial equivalence determination, not a study demonstrating the device meets pre-defined acceptance criteria for performance metrics (like sensitivity, specificity, etc.) against a specific ground truth.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or reported device performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it states that the device was found to have "similar technological characteristics and to be equivalent" to a predicate device.

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable or not provided. The submission relies on a comparison of technological characteristics to a predicate device, not on clinical performance testing with a specific test set.
• Data provenance: Not applicable or not provided.

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

• Not applicable or not provided, as no specific test set requiring expert ground truth for performance evaluation is described.

4. Adjudication method for the test set:

• Not applicable or not 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:

• No MRMC study was conducted or described. This device is an X-ray system that produces digital radiographs, not an AI-powered diagnostic tool for interpretation.

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

• Not applicable. The device is described as "software processes standard dental images captured from a sensor device," indicating it's an imaging system, not an algorithm providing standalone diagnostic output. Its performance is evaluated based on its technical similarity to a predicate device.

7. The type of ground truth used:

• Not applicable. The submission is based on a substantial equivalence to a predicate device, meaning the comparison is based on technical specifications and intended use, not a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. The device is an imaging system, not a machine learning algorithm that requires a training set.

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

• Not applicable.

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