(244 days)
TI-MAX Z45 is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials.
The Ti-MAX Z45 is a contra-angle dental handpiece which is powered by either an air-motor or electronic-micromotor for use in general dentistry. The TI-MAX Z45 is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The Tr-MAX Z45 transmits rotational force from the motor to the gears through a clutch, and then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur is able to cut and grind teeth and dentures using the rotation force.
The provided text describes a 510(k) summary for a dental handpiece, the TI-MAX Z45. This document focuses on demonstrating substantial equivalence to predicate devices through various comparisons and bench testing. It does not contain information about clinical studies with human readers or AI algorithms for diagnostic purposes. Therefore, many of the requested categories related to clinical studies and AI performance cannot be addressed.
Here's the information that can be extracted from the provided text, primarily focusing on the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TI-MAX Z45 are based on compliance with the international standard ISO 7785-2, which is also used for the predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Compliance with ISO 7785-2 | All TI-MAX Z45 samples were compliant with ISO 7785-2 |
The text also provides specific performance characteristics, although these are not explicitly labelled as "acceptance criteria" but rather as "performance" metrics within the comparison table:
| Performance Metric | TI-MAX Z45 Reported Value |
|---|---|
| Eccentricity | 0.016 mm |
| Force for bur extraction | 25.3N |
| Flow Rate (Coolant Water) | More than 50 ml/min |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "All TI-MAX Z45 samples were compliant with ISO 7785-2". However, the exact sample size for the bench testing is not specified in the provided text.
The data provenance is from bench testing performed by the manufacturer, NAKANISHI, INC., a company located in Japan. The study is not a clinical study involving patient data and therefore the terms "retrospective or prospective" do not apply in the usual sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device's acceptance was established through compliance with an engineering standard (ISO 7785-2) via bench testing, not through expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. This was bench testing against a standard, not a clinical study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the regulatory submission for a physical dental handpiece, not an AI software or a diagnostic tool that would typically involve human readers and comparative effectiveness studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a hardware device (dental handpiece), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance regarding safety and effectiveness was established by compliance with the international standard ISO 7785-2. This is an engineering/performance standard for dental handpieces.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a hardware device and does not involve a training set as understood in the context of AI development.
§ 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.