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The Endo Tabletop consists of a motorized endodontic handpiece for root canal cleaning and preparation. In addition, some models may also incorporate an electronic apex locator that assists the operator to locate the file tip in the root canal. The Endo Tabletop is intended solely for use by trained dental professionals on patients that need root canal treatment.

The Endo Tabletop is designed to drive dental endodontic instruments for a rotating treatment of root canals. Therefore, the Endo Tabletop provides different kinds of movement:

1. Continuous rotary motions (adjustable speed, torque and direction depending on the file used)
2. Reciprocating motions (speed, torque, direction, and angles depending on the file used)
   This functionality is provided by a Brushless Direct Current (BLDC) motor having speed and torque controls. The motor speed control is driven by a dedicated controller using pulse width modulation (PWM) of the excitation voltage and the motor torque control is performed by controlling and limiting the maximum current flow. The contra-angle transmits the motor movement in speed and direction to the endodontic file.
   The user can set the device by a graphical user interface on a 7" touch Thin-Film Transistor (TFT) display. The handpiece can be started/ stopped with a finger switch and foot control.
   All models can also be used for root canal length determination using the integrated apex locator functionality. This apex locator functionality is provided by evaluating the electical impedance between to the file clamp, placed into the dental root canal and the lip clip placed on the patient. The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray.
   The proposed apex locator function has two modes standalone mode. In standalone mode, the apex determination works with the lip and the endodontic file, which is connected to a file clamp. In combined mode, the apex determination works with the lip clip and the endodontic file which is connected to the contra-angle.

This is a 510(k) summary for a dental handpiece with an apex locator. The document does not contain the specific acceptance criteria and detailed study results in the format requested.

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria and reported device performance with specific numerical values for metrics like accuracy, precision, or other quantitative measures typically found in performance studies. Instead, it lists various standards and guidance documents that the device's testing complied with. For example, it states:

• "All testing to the applicable elements of the standard passed." (referring to ISO 14457:2017)
• "Results confirm that the design inputs, function, and performance specifications for the proposed device are met."
• "performance data support the conclusion that the proposed device performs as well as the predicate device EndoPilot2 (K202906)."

This implies that the device met the requirements outlined in these standards, but the specific performance data against those requirements is not detailed in this summary.

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

The document does not specify the sample size used for any of the performance tests (e.g., how many devices were tested for endurance, how many measurements were taken for the apex locator accuracy). It also does not mention the data provenance in terms of country of origin or whether studies were retrospective or prospective.

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)

This section is not applicable as there is no mention of a human-read or expert-adjudicated test set in the document. The testing described focuses on mechanical, electrical, software, and biocompatibility performance of the device and does not involve human interpretation or classification of medical images/data.

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

This section is not applicable as there is no mention of a human-read or expert-adjudicated test set in the document.

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 section is not applicable. The device described is a dental handpiece and electronic apex locator, which are physical tools, not AI-driven diagnostic software that would typically be involved in MRMC studies to assess human reader improvement. The document explicitly states, "There are no clinical tests submitted, referenced or relied on in the 510(k) for a determination of substantial equivalence."

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

The device is not an algorithm, so the concept of standalone algorithm performance does not directly apply. However, the performance of the apex locator functionality (e.g., its accuracy in determining file tip position) would be considered part of its standalone performance. The document states:

• "The apex location is the same, at ≤ 0.5 mm." This refers to the accuracy of the apex locator functionality compared to the predicate device.
• "File performance (speed/torque) is determined by the system consisting of contra-angle and motor together."
• Various non-clinical tests were conducted to confirm the performance, including those conforming to ISO 14457:2017.

While specific numerical results beyond "≤ 0.5 mm" for apex location are not provided in this summary, the mentioned tests represent the standalone performance evaluation of the device's functions.

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

For the apex locator, the "ground truth" would likely be established through a reference method, such as direct measurement on extracted teeth validated by X-ray or micro-CT, or comparison to a clinically accepted gold standard. The document mentions: "The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray." However, it does not explicitly state how the "≤ 0.5 mm" accuracy was determined or what the ground truth method was for the performance testing.

For other aspects like mechanical, electrical, and biocompatibility testing, the "ground truth" is defined by the requirements of the relevant international standards (e.g., ISO 14457:2017, IEC 60601 series, ISO 10993 series).

8. The sample size for the training set

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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