(106 days)
The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.
The NuTorque Programmable Electric System is an electric handpiece system for use in performing various dental procedures including grinding and trimming. post and pin drilling, pin setting, finishing, polishing, endodontic, caries removal and prophylaxis.
The NuTorque Programmable Electric System is composed of a power supply. control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100- 40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.
The provided text is a 510(k) summary for the NuTorque Programmable Electric System, a dental handpiece system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information regarding detailed acceptance criteria for the device's performance, nor does it describe specific studies with sample sizes, expert involvement, or ground truth establishment relevant to the request.
The text mentions:
- "Performance testing was conducted to validate the safety and effectiveness of the NuTorque Programmable Electric System."
- "This testing included the electrical safety, electromagnetic compatibility and validation and verification of the software."
- "Testing was completed in accordance with recognized consensus standards."
Based on the provided text, I cannot complete the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the given document.
The document focuses on demonstrating substantial equivalence to a predicate device (Ti-Max NL400), which is a regulatory pathway that often relies on comparing technical characteristics and intended use rather than requiring extensive clinical performance studies with specific acceptance criteria and validation metrics as might be found for novel diagnostic AI devices.
Therefore, the table below will reflect the absence of the requested information from the provided document.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
Study Details (Based on provided text)
- Sample size used for the test set and the data provenance: Not specified in the provided document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided document.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable/Not specified in the provided document. This device is a dental handpiece system, not an AI diagnostic tool that would typically involve human reader performance studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not specified in the provided document. This device is a physical dental instrument system, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided document for performance testing. The document states "Performance testing was conducted to validate the safety and effectiveness" but does not detail the methodology for establishing ground truth for mechanical/electrical performance.
- The sample size for the training set: Not applicable/Not specified in the provided document. This is not an AI/machine learning device that would have a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable/Not specified in the provided document.
§ 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.