(2 days)
To be used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
The ProDrive Replacement Turbine is a high-speed air-powered turbine designed to be installed in existing, legally marketed dental handpieces. The ProDrive Replacement Turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation. When fully seated, the length that the ProDrive bur extends from the handpiece is the same as that of the standard bur/turbine assembly. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance. Because of the unique geometry of the ProDrive Replacement Turbine it is appropriate for use only in combination with ProDrive carbide and diamond cutting instruments. Standard round-shank burs will not fit into the ProDrive chuck, preventing their unintended use. ProDrive burs, however, will fit in traditional friction-grip chucks and will meet appropriate performance requirements when used in this way. With the exception of the unique drive-lock spindle, the ProDrive Replacement Turbine consists of commercially available replacement parts currently used to refurbish dental handpieces in the United States. The spindle is composed entirely of stainless steel. The predicate device spindle is also manufactured from stainless steel. Therefore, the products are considered to be identical in materials used in their manufacture. ProDrive burs are composed of tungsten vanadium stainless steel, coated with carbide or diamond cutting surfaces. The ProDrive burs are machined for ProDrive Systems Inc. by the bur manufacturer to the unique shank geometry required by the ProDrive drive-lock mechanism. In all other respects the burs are identical to commercially available burs currently distributed in the United States. The use of stainless steel in the manufacture of ProDrive spindles and burs ensures biocompatibility and resistance to corrosion.
This document describes the ProDrive Replacement Turbine, a dental device, and its conformity to established standards.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the ProDrive Replacement Turbine "meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E)." It then lists specific characteristics that this standard addresses.
| Acceptance Criteria (from ISO 7785-1:1997(E)) | Reported Device Performance |
|---|---|
| Extraction force | Meets or exceeds standard |
| Resistance to corrosion | Meets or exceeds standard |
| Torque | Meets or exceeds standard |
| Noise level | Meets or exceeds standard |
| Eccentricity | Meets or exceeds standard |
| Speed | Meets or exceeds standard |
| Air pressure | Meets or exceeds standard |
| Sterility validation | Meets or exceeds standard |
| Stall torque | Meets or exceeds standard |
| Reprocessing | Meets or exceeds standard |
Furthermore, the document states: "Extensive testing indicates that after 250 sterilization cycles the ProDrive Replacement Turbine continues to meet all performance requirements."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the performance testing. It simply refers to "Extensive testing." The data provenance (country of origin, retrospective/prospective) is also not detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish a "ground truth" in the way it's typically understood for AI/diagnostic studies. The testing appears to be based on adherence to a recognized international standard (ISO 7785-1:1997(E)) and device-specific performance evaluations. Therefore, no information on the number or qualifications of experts is provided.
4. Adjudication Method
Since the testing is against a standard and doesn't involve subjective interpretation by multiple experts establishing a "ground truth" from complex data (like medical images), an explicit adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The study focuses on the device's technical performance against a standard and in comparison to a predicate device, not on diagnostic accuracy improvements with AI.
6. Standalone (Algorithm Only) Performance Study
No. The ProDrive Replacement Turbine is a mechanical dental handpiece component, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not applicable.
7. Type of Ground Truth Used
The "ground truth" in this context is defined by the performance requirements outlined in ISO 7785-1:1997(E) and the comparative performance against a legally marketed predicate device. This is a standards-based and objective measurement-based "ground truth," rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied 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.