(388 days)
The turbines of the T1 / T2 / T3 Turbine family are intended for the
- Preparation of cavities and crowns
- Removal of carious material
- Removal of fillings
- Processing of tooth and restoration surfaces
- Reducing hard tooth structure
The Sirona Dental Systems T1 / T2 / T3 turbine family consists of air powered, high speed handpieces. The handpieces are reusable, ergonomically shaped and include (T1 and T2 Turbines) a fiber optic light system. The water delivery geometry includes 4 pair of water / air spray nozzles just below the head with one way retraction valves to prevent the ingress of external water or air, when the spray system is shut down. The devices are sterilizable in an autoclave. The turbines are provided in three variants: control, boost and mini.
In addition, the turbines are compatible with the following quick-coupling:
- Sirona R coupling
- Sirona F coupling
- Sirona B coupling
- KaVo coupling
- W&H coupling
- NSK MachLite coupling
- NSK QD-J coupling
This document is a 510(k) summary for a dental device, specifically the Sirona Dental Systems T1 / T2 / T3 Turbine family. Due to the nature of the device (a dental handpiece) and the regulatory submission (510(k)), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the context of demonstrating substantial equivalence to predicate devices, rather than through formal clinical trials with specific performance metrics such as sensitivity, specificity, or accuracy, which are typical for diagnostic or AI-driven devices.
Here's a breakdown based on the provided text, addressing your questions where applicable and noting where the information is not relevant to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are predominantly compliance with recognized international standards and demonstration of similar technological characteristics and performance to predicate devices. The "reported device performance" is a comparison of these characteristics to the predicate devices.
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (Sirona T1 / T2 / T3 Turbine family) | Predicate Device 1 (Nakanishi Ti-Max X) | Predicate Device 2 (Morita Twin Power) |
|---|---|---|---|
| Principle of Operation (Air-driven turbine) | Turbine, Air driven | Turbine, Air driven | Turbine, Air driven |
| Couplings to Treatment Chair (Compatibility with common couplings) | Sirona, Kavo, NSK, W&H | Sirona, Kavo, NSK, W&H, Bienair | Sirona, Kavo, NSK, W&H, Morita |
| Speed Range (Comparable to predicates) | 250,000 - 400,000 rpm | 300,000 - 450,000 rpm | 320,000 - 400,000 rpm |
| Power [W] (Comparable to predicates) | 22/23/20 W | 16-22 W | 18-22 W |
| Chuck (Push button FG) | Push button FG | Push button FG | Push button FG |
| Light Intensity [lux] (If applicable, comparable to predicates) | 25,000 lux | Data not available | 25,000 lux |
| Intended Use (Matching or equivalent to predicates) | -Preparation of cavities & crowns | ||
| -Removal of carious material | |||
| -Removal of fillings | |||
| -Processing of tooth & restoration surfaces | |||
| -Reducing hard tooth structure | ...removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. | ...for use by authorized persons in the practice of the dentistry. | |
| Compliance with ISO Standards (14457, 1797, 9168, 21531) | Complies with ISO 14457, ISO 1797, ISO 9168, ISO 21531 | Implicitly compliant for predicates | Implicitly compliant for predicates |
| Sterilization Process (Validation) | Validation performed | Not explicitly stated for predicates, but implied by class | Not explicitly stated for predicates, but implied by class |
| Device Effectiveness (Validation) | Validation performed | Not explicitly stated for predicates, but implied by class | Not explicitly stated for predicates, but implied by class |
| Biocompatibility (Validation) | Validation performed | Not explicitly stated for predicates, but implied by class | Not explicitly stated for predicates, but implied by class |
| Quick Coupling (Reverse engineering) | Reverse engineering conducted | Not explicitly stated for predicates, but implied by design | Not explicitly stated for predicates, but implied by design |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable to this type of device submission. The submission is for a mechanical dental handpiece, and its performance is evaluated through engineering tests, compliance with standards, and comparison of technical specifications to legally marketed predicate devices, not through a "test set" of patient data or clinical cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of device submission. There is no concept of a "ground truth" derived from expert consensus for a mechanical dental handpiece in the way it would be for an AI diagnostic device. The ground truth, in a technical sense, would be defined by engineering specifications and material properties, validated through laboratory testing.
4. Adjudication Method for the Test Set
This is not applicable to this type of device submission. There is no "test set" requiring adjudication in the context of a mechanical handpiece's 510(k) submission.
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
This is not applicable to this device. It is a traditional mechanical dental handpiece, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, AI integration, or human reader improvement metric is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical dental handpiece; there is no algorithm, AI, or software component that operates in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is established through adherence to international standards (ISO 14457, 1797, 9168, 21531), engineering specifications, and validation through laboratory performance testing related to sterilization, device effectiveness, and biocompatibility. There is no patient-specific "ground truth" in the clinical sense mentioned (pathology, outcomes data, expert consensus). The performance is measured against objective, quantifiable physical and sterile conditions.
8. The Sample Size for the Training Set
This is not applicable to this device. There is no "training set" as it is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable to this device. There is no "training set."
§ 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.