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EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating endodontic instruments with torque control, or retreatment of an already treated tooth, with integrated apex locator.

EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating endodontic instruments with torque control, or retreatment of an already treated tooth, with integrated apex locator. We can identify two different functional principles: one is the motor function which serves to shape the root canal the other is the apex locator function to determine the apex approach when the file is in the root canal. The motor function, when the file has a movement transmitted from the motor through the contra-angle, allows the proper shaping of a root canal with infected pulp through rotary or reciprocating movement, helping to remove debris and infected tissue from the canal.

The motor, controlled in speed and torque, uses brush less DC technology with 3 phases and 3 Hall sensors, driven by an embedded software. The apex locator function allows to determine when, during an endodontic treatment, the tip of an endodontic instrument, in steel or nickel-titanium, inserted by the dentist inside the root canal, is at the apex of the canal.

Two electrodes are applied to the patient, a lip clip on the lip and a file clamp to the endodontic instrument positioned inside the canal. When the device signals the apex has been reached, the dentist positions the instrument stopper on the dental crown and indirectly goes to measure the working length of the canal using a ruler for endodontic: instruments, so the length from which the dentist must remove the infected pulp.

The provided FDA 510(k) Clearance Letter for EnDrive (EnDriveUS) outlines the device's technical specifications and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with a detailed test set, ground truth, expert adjudication, or MRMC study).

The document primarily focuses on demonstrating substantial equivalence through bench testing of key performance characteristics and compliance with various standards.

Here's a breakdown of the information available and what is not disclosed in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7), here's the information that can be extracted:

Note: The "acceptance criteria" for EnDrive are largely implicitly defined by its substantial equivalence to the predicate device (Endo Motor, K220829). The document states that EnDrive's performance is either within or acceptably comparable to the predicate's ranges.

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

• Sample Size for Test Set: Not specified. The document mentions "bench test reports" but does not provide details on the number of samples, root canals, or measurements included in these tests for speed, torque, or apex locator accuracy.
• Data Provenance: Not explicitly stated as "country of origin." However, the applicant is "Advanced Technology Research (A.T.R.) s.r.l." located in Pistoia, Italy. The testing described appears to be a non-clinical, bench-top study rather than a human clinical trial, making "retrospective or prospective" less applicable in the typical sense. It implies prospective testing conducted on the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable/Not specified. For the bench tests described (motor speed, torque, apex locator accuracy), the "ground truth" would typically be established by calibrated measurement instruments, not human experts. Human experts are generally relevant for interpreting images, diagnosing conditions, or performing clinical assessments, none of which are described in the performance tests here.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess data, and disagreements need to be resolved. Since the reported performance tests are bench-top measurements against instrument-derived "ground truth," such a method is not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document does not describe any study involving human readers assessing cases with or without AI assistance. The device is a "motorized handpiece with integrated apex locator," not an AI diagnostic/interpretive tool in the context of MRMC studies.
• Effect size of improvement with AI vs without AI assistance: Not applicable, as no MRMC study was conducted or described.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop)

• Was a standalone study done? Yes, in essence. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section describes performance characteristics (motor speed, apex locator accuracy, torque) of the device itself, implying standalone performance. The device's "integrated apex locator" function is a component of the device's overall functionality, and its accuracy (±0.5mm) is reported as a standalone metric for that function.
  • However, it's crucial to distinguish this from AI/software-only standalone performance. This is about the electromechanical performance of the hardware and its integrated functions, not a purely software-based diagnostic algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the reported performance metrics (motor speed, torque, apex locator accuracy), the ground truth would be established by calibrated reference instruments or precise physical measurements. For example:
  • Motor Speed: A calibrated tachometer or speed sensor.
  • Torque: A calibrated torque sensor.
  • Apex Locator Accuracy: Physical measurement of root canal length (e.g., using a micrometer or precise ruler) in a controlled phantom/model alongside electronic readings.
  • General compliance with standards implies that the tests performed to meet those standards would use appropriately robust and validated ground truth methodologies.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified/Not applicable in the AI/ML sense. The EnDrive is described as an electronic medical device with embedded software controlling motor functions and an apex locator. While "embedded software" runs the device, the document does not suggest the use of machine learning or AI models that would require a distinct "training set" in the context of typical AI/ML submissions to the FDA (e.g., for diagnostic image analysis). The software likely relies on algorithms and control logic rather than learned patterns from a training dataset.

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

• How Ground Truth for Training Set Was Established: Not applicable/Not specified. As there's no mention of a machine learning "training set," there's no information on how its ground truth would be established. The device's functionality is based on established engineering principles for electromechanical control and impedance-based apex localization, not typically on a data-driven training paradigm requiring labeled ground truth in the way a diagnostic AI does.

In summary: The provided FDA clearance letter focuses on establishing substantial equivalence for a medical device (a dental handpiece with an integrated apex locator) primarily through bench testing against performance specifications and compliance with relevant industry standards. It does not detail a clinical study with elements like a human-adjudicated test set, MRMC comparisons, or specific AI/ML training data that your request implies. The performance claims are limited to the mechanical and electronic accuracy of the device's core functions.

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The ATR5000, LC5000 and Implant System are intended for the preparation of intra-oral bone for implantology procedures. These ATR Surgical Micromotors are intended to prepare Intraoral bone for implantology procedures.

The ATR Surgical Micromotors ATR5000, LC5000 and Implant System, are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System consists of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The units also house the peristaltic pump. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System provide electronic control of velocity and torque. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System can be programmed and retain programs in memory. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System are fully operational from foot pedal.

This document describes acceptance criteria and testing for the ATR Surgical Micromotors (ATR5000, LC5000, and Implant System), which are microprocessor driven surgical micromotors used in implantology procedures.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated by its compliance with a series of electrical, safety, and electromagnetic compatibility (EMC) standards. The acceptance criteria essentially are compliance with these listed standards.

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

• Sample Size: The document does not specify a numerical "sample size" in terms of number of devices tested. It refers to "All evaluation of the ATR 5000, LC5000 and Implant System" being performed. This implies at least one unit of each model (ATR5000, LC5000, and Implant System) was tested.
• Data Provenance: The tests were "performed by certified body Laboratory," but the specific country of origin for the data is not explicitly stated. The submitting company (ATR srl) is based in Italy, suggesting the testing might have been done in Italy or a European certified lab. The predicate device was also evaluated "with the same regulation standard," indicating historical consistency in testing approach.
• Retrospective or Prospective: Not applicable in the context of device performance testing against engineering standards. This is a prospective testing of the manufactured device models.

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

This information is not applicable to this type of device submission. The "ground truth" here is compliance with established engineering and safety standards, not a medicaldiagnosis or interpretation by experts. The "certified body Laboratory" acts as the independent verifier of compliance.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where conflicting expert interpretations need resolution. For compliance testing against engineering standards, the results are objectively measured against the standard's specifications.

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 information is not applicable. MRMC studies and the concept of "human readers" improving with "AI assistance" are relevant to diagnostic imaging devices or other AI-enabled tools for interpretation. This submission is for surgical micromotors, which are hand-held mechanical and electronic devices, not AI-driven diagnostic tools.

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

This information is not applicable. This device is a surgical micromotor, not a software algorithm. Its performance is evaluated through physical and electrical tests, not algorithmic performance.

7. The type of ground truth used

The "ground truth" in this context is the specific technical requirements and limits defined by the listed international and national standards (e.g., UL 2601-1, IEC 60601-1, IEC 60601-1-2, IEC 61000 series, ISO 11498). The device is deemed safe and effective if its measured performance falls within the acceptable parameters set by these standards.

8. The sample size for the training set

This information is not applicable. Surgical micromotors are hardware devices that do not use machine learning algorithms, and therefore, there is no "training set."

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

This information is not applicable for the same reason as above; there is no training set for this type of medical device.

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