(101 days)
The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.
The TCM Endo 20 is a transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor. It is a microprocessor controlled electronic motor system which controls the rotational speed and the torque of the motor. The rotational speed is constant until the torque reaches the adjusted level. In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode. The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting).
The provided text is a 510(k) summary for the NOUVAG AG TCM Endo 20 device. It states that the device is substantially equivalent to a previously cleared device (NOUVAG AG TCM Endo V K042822). The summary explicitly states: "The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product."
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Study for NOUVAG AG TCM Endo 20
This 510(k) submission for the NOUVAG AG TCM Endo 20 is for a dental root treatment device. As such, the primary method for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than a clinical study with detailed performance metrics and acceptance criteria as would be seen for novel or high-risk devices. The submission indicates that the device has been designed and tested to applicable safety standards and is substantially equivalent to other legally marketed devices in the United States and functions in a similar manner for the same intended use.
Therefore, the "acceptance criteria" here are generally related to meeting recognized safety standards and demonstrating that the device's technical characteristics and intended use are comparable to the predicate. The "study" proving this largely relies on engineering and performance testing to ensure it operates equivalently to the predicate, not a clinical trial measuring diagnostic accuracy or treatment efficacy.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical and electrical safety via applicable standards. | "The TCM Endo 20 has been designed and tested to applicable safety standards." |
| Functional equivalence to the predicate device (TCM Endo V K042822). | "The TCM Endo 20 functions in a manner similar and is intended for the same use as the TCM Endo V (Predicate device)." |
| No new issues of safety, effectiveness, or performance. | "The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product." |
| Compliance with regulatory requirements (GMP, labeling, etc.). | (Implicitly asserted by submitting for 510(k) clearance) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the traditional sense (e.g., patient data). The testing mentioned is primarily non-clinical, likely engineering and performance testing to verify adherence to safety standards and functional specifications. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable or provided for a clinical test set.
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 information is not applicable and not provided. The substantial equivalence argument relies on comparing device specifications and intended use to a predicate, not on a clinical ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set with adjudicated ground truth is described.
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
Not applicable. This device is an endodontic motor, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this device filing, the "ground truth" for substantial equivalence is primarily the established safety and effectiveness profile of the predicate device, demonstrated through non-clinical testing against engineering specifications and applicable standards for the new device.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.