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The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.

The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes the EndoPilot2, a dental device, for which the manufacturer, Schlumbohm GmbH & Co. KG, sought 510(k) clearance from the FDA. The submission (K202906) claims substantial equivalence to predicate devices: EMS-200 and SUPRASSON P5 NEWTRON. The document details the non-clinical performance data used to support this claim.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against which specific quantitative numerical performance metrics of the EndoPilot2 are directly compared. Instead, it describes various non-clinical performance tests conducted and states that the device "PASSED required testing" or "all requirements were met."

Therefore, I will extract the performance specifications and the stated outcome for the most relevant functional components where quantitative values are mentioned, and then for other types of tests, I will summarize the general pass/fail outcome.

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

The document does not specify a "test set" in the context of patient data or clinical images. The performance data presented are from non-clinical (bench) tests on the device itself, comparing its specifications and performance to established standards or predicate devices. No information is provided regarding the sample size of devices tested or any provenance related to patient data (country of origin, retrospective/prospective). This is typical for a 510(k) for a device like this, which relies on engineering and standards compliance rather than clinical study data.

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

This question is not applicable to the provided information. No "test set" with ground truth established by experts (e.g., radiologists) is mentioned. The studies are non-clinical engineering and performance tests against defined technical specifications and standards.

4. Adjudication Method for the Test Set

This question is not applicable. There is no mention of an adjudication method as there were no expert assessments of a test set. The compliance was determined by technical testing and validation against standards.

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

This question is not applicable. The EndoPilot2 is a physical dental device for root canal procedures, not an AI-powered diagnostic or assistive tool for human readers interpreting medical images. Therefore, an MRMC study and effects of AI assistance are outside the scope of this submission.

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

This question is not applicable. The device is not an algorithm, but a physical system of integrated dental tools. The performance refers to the device's functional capabilities (e.g., motor speed, torque, temperature control, apex locator accuracy) and compliance with safety and design standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests, the "ground truth" or reference points were:

• Predicate Device Specifications: The technical specifications (e.g., apex locator accuracy, motor speed ranges, obturation temperatures, ultrasonic frequency) of the legally marketed predicate devices (EMS-200 and SUPRASSON P5 NEWTRON).
• International and National Standards: Recognized standards for medical device safety, biocompatibility, electromagnetic compatibility, reprocessing, software, usability, and risk management (e.g., ISO 10993, IEC 60601-1, IEC 62304, EN ISO 14971, ISO 3964, ISO 14457).

8. The Sample Size for the Training Set

This question is not applicable. The EndoPilot2 is a hardware device, not an AI model that requires a training set.

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

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

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