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The SiroEndo is intended for dental root canal length measurement and root canal treatment.

The SiroEndo is an electronic digital control system indicated for endodontic treatment that allows a dentist to locate the anatomical root canal apex and to obtain root canal length measurements. The SiroEndo system is comprised of the central unit mounted via a support arm to a dental unit, micromotor, foot pedal and power supply. The central unit electronically controls the micromotor's rotation speed, rotation direction and torque. A commercially available handpiece is attached to the micromotor. Systems of files are selectable with corresponding preset values for rotation speed and torque that are adjusted according to the entered handpiece reduction ratio. Individual values of rotation speed and torque can be entered and saved. File systems with individual values of rotation speed and torque can be stored in an internal memory or on a SiroEndo memory stick and can be re-called. The SiroEndo incorporates a selectable auto-stop and auto-reverse function triggered when the selected torque has been reached. The SiroEndo offers a selectable apex locator feature that makes the distance between file tip and apex visible. The motor stops, if programmed, when the apex has been reached.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It primarily focuses on the regulatory submission and determination of substantial equivalence for the Sirona Dental Systems SiroEndo device to a predicate device.

However, based on the information provided, here's what can be extracted and what is missing:

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

Missing Information: The document states that "Performance testing to validate the safety and effectiveness of the SiroEndo included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions." However, it does not specify the acceptance criteria (e.g., specific thresholds for accuracy, tolerance levels for electrical parameters) for these tests, nor does it provide the results of these tests in a quantitative or qualitative manner beyond stating that they were conducted.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

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)

Not mentioned in the document. The document describes internal performance testing, but not a study involving human experts to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not mentioned, as there is no description of a study involving a test set with human adjudication.

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

Not mentioned or implied. This device is described as an electronic digital control system for endodontic treatment including an apex locator, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers.

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

The document mentions "validation testing of both hardware and software functions" and "The SiroEndo offers a selectable apex locator feature that makes the distance between file tip and apex visible. The motor stops, if programmed, when the apex has been reached." This implies standalone testing of these functionalities, but no specific study details (like sample size, methodology, or quantitative results) are provided.

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

Not explicitly stated for any of the performance tests. For the apex locator function, the ground truth would inherently relate to the actual anatomical apex location, likely determined by methods like direct visualization, radiographic comparison, or histological analysis during development/validation, but this is not detailed in the document.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning or AI model that typically requires a distinct training set. The device's functionality is based on electronic measurements and control, not learned patterns from data.

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

Not applicable for the same reason as #8.

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