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For use by dentists in standard endodontic procedures using rotary endodontic files or reciprocating endodontic files or use by dentists in periodontics, endodontics, scaling, prosthesis procedures with ultrasonic tips.

The ENDO CENTER is an electric motor-driven handpiece combined with an ultrasonic scaler intended for root canal preparation procedures in endodontic industry. In ULTRASONIC mode, the device is able to drive piezo-electric resonator for root canal treatment at selectable power and fixed frequency . In ROTATING mode, the device is able to drive electrical micromotor for rotary files for root canal treatment at selectable speed and torque. In RECIPROCATING, mode, the device is able to drive electrical micromotor for reciprocating files for root canal treatment at selectable speed and rotational angle. The New Device is a combination of two existing devices already in consolidated use in endodontic field.

The provided text describes a 510(k) submission for a dental device called ENDO CENTER. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against predefined acceptance criteria through a clinical study. Therefore, much of the requested information (such as sample sizes, expert qualifications, and adjudication methods for a clinical study) is not present in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in the typical sense of a clinical trial (e.g., a specific statistical endpoint to be met). Instead, the performance evaluation was conducted to demonstrate similarity to the predicate devices. The "evaluated Performances" section lists the parameters that were compared.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a non-clinical bench test comparing the performance of the ENDO CENTER device to its predicate devices: I-ENDO DUAL (for motor functions) and SUPRASSON P5 NEWTRON (for ultrasonic functions). The document states, "After tests, the obtained results for the New Device have been directly compared to the Predicate Device Performances. The results of the comparison show that the Performances of the New Device and the Predicate Device are similar."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The study was a non-clinical bench test, so "sample size" would likely refer to the number of units tested, but this information is not provided.
• Data Provenance: The tests were non-clinical bench tests, likely performed by the manufacturer (SATELEC) at their facility in France. The provenance is therefore internal R&D/engineering data. It is retrospective in the sense that the device was developed and then tested against existing predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the study was a non-clinical bench test comparing technical specifications, not a clinical study requiring expert ground truth for diagnostic accuracy or similar endpoints. The "ground truth" was the technical specifications and measured performance of the predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as the study was a non-clinical bench test. No human adjudication was involved in comparing the technical performance parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a dental handpiece and scaler, and the evaluation relies on demonstrating technical equivalence and safety based on existing technologies, not on human reader performance with or without AI assistance.

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

This is not applicable. The device is a physical dental instrument, not a medical AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" was essentially the measured performance and technical specifications of the predicate devices. The new device's performance (ultrasonic frequency, motor speed, motor torque) was compared directly to these established benchmarks of the predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. It is a physical medical device, not an AI model that requires training data.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set for this type of device.

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