(14 days)
To be used in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.
The ProDrive line of high-speed air-driven dental handpieces includes two models - the ProDrive Mini and ProDrive Standard. These models are each available with one of a variety of quick couplings for use with: Sirona, KaVo, W&H, Bien-Air, NSK Mach and NSK QD-J connections. In addition, the PD Standard model comes in a fixed coupling format for MidWest handpiece users. The handpieces come supplied with a halogen light source of approximately 25,000 lux and a 3 jet spray for water. Every ProDrive handpiece is equipped with the previously-cleared ProDrive turbine as the standard drive mechanism. The ProDrive 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. 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.
The provided document is a 510(k) Summary for a dental handpiece. It describes the device, its intended use, and a comparison to a predicate device. However, it does not include detailed study results, acceptance criteria with reported performance, or specific information about ground truth establishment, expert adjudication, or sample sizes for testing or training sets in the way that would typically be presented for a diagnostic AI/ML device.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to performance standards for mechanical devices.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The ProDrive line of dental handpieces meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E). Extensive testing indicates that after 250 sterilization/use cycles the ProDrive handpiece continues to meet all performance requirements."
This is a general statement rather than a table with specific criteria and numerical performance results. Without the actual ISO 7785-1:1997(E) document, the specific acceptance criteria cannot be listed. The reported performance is a qualitative statement of meeting/exceeding standards after 250 cycles.
| Acceptance Criteria (from ISO 7785-1:1997(E)) | Reported Device Performance |
|---|---|
| Specific performance requirements as outlined in ISO 7785-1:1997(E) for dental handpieces. | Meets or exceeds all applicable performance standards outlined in ISO 7785-1:1997(E) after 250 sterilization/use cycles. |
2. Sample size used for the test set and the data provenance
Not explicitly stated. The document mentions "Extensive testing," but does not provide details on sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable.
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 is a mechanical device, not an AI/ML-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device.
7. The type of ground truth used
For this type of mechanical device, "ground truth" would relate to objective performance metrics measured against engineering specifications and international standards (ISO 7785-1:1997(E)). It's not about clinical diagnostic ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a "training set" would be used.
9. How the ground truth for the training set was established
Not applicable.
§ 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.