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The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.

The TCM Endo V is a transportable, cord connected, microprocessor-controlled endodontic device with Apex Locator. It is provided with a plastic enclosure which has four electrical connection ports for the detachable power supply cord, the foot-control, the micro-motor and the reference electrode (lip connector). The Apex Locator measures the distance between file tip and Apex. If a minimum distance is preselected, the selected auto-control mode is activated thus ensuring that the minimum distance is reached. The speed is held constantly under all circumstances until the maximum adjusted torque limit is reached. The Automatic Torque Control (ATC) protection mode ensures that no file breakage occurs. Once the preselected torque limit has been reached, the motor will immediately reverse for one revolution, then returns to forward direction. This ensures a fast and effective root canal preparation. The following parameters can be set by the user; - mains voltage (100V/115V/230V) - rotational speed (150-2000 rpm) - "Apex adjust" (-1 to 0) - automatic torque limitation "ATC" (5-40Nmm) - "Auto control" mode ("Auto Slow / Down", "Auto Reverse"; "Auto Stop") - micro-motor ON/OFF "Motor"

This 510(k) premarket notification for the NOUVAG AG TCM Endo V does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance.

This document is a 510(k) summary, which is a high-level overview submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically focuses on the device's intended use, technological characteristics, and a brief summary of non-clinical tests.

Here's why the requested information is not present in the provided text:

• Acceptance Criteria and Reported Device Performance: This document states that "The TCM Endo V has been designed and tested to applicable safety standards." and "The TCM Endo V does not raise any new issues of safety, effectiveness, or performance of the product." However, it does not provide specific acceptance criteria (e.g., accuracy percentages, specific tolerances for apex localization) or report the results of any specific performance studies against those criteria. Such details would typically be found in a more comprehensive device validation report, which is part of the full 510(k) submission but not usually included in the publicly available summary.
• Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details: These are all aspects related to a detailed clinical or performance study. The provided text is a regulatory summary and does not include the methodology or results of any such studies. The device is for "dental root canal measurement and treatment" and mentions an "Apex Locator," implying that accuracy in length measurement would be critical, but no data on this is presented.

Based only on the provided text, I cannot complete the table or answer the specific questions about the study. The summary aims to establish substantial equivalence for regulatory purposes, not to present detailed scientific performance data.

The FDA's decision letter (K042822) confirms the substantial equivalence based on the submitted information, but it also does not contain the detailed study results.

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