(135 days)
The 430 Torque High-Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparation.
The 430 Torque High-Speed Handpiece Series consists of a fiber optic high speed handpiece, marketed as a SWL and a non-fiber optic handpiece, marketed as a SW handpiece. Each is a pneumatically driven hand- held device that is capable of reaching rotational speeds of 350,000 to 450,000 rpms at a recommended air pressure of 38-43 PSI. The series delivers on average up to 20 watts of power providing .269 oz.-in. of stall torque. The handpieces are constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur, and incorporates lubefree ceramic bearings (K905155) and a push button autochuck. The rotor is larger than the rotor of the predicate, yielding a higher cutting torque. The fiber optics in the SWL version of the handpiece are lead-free, multi-core glass rod that transmit light from the fiber optic swivel coupler to the oral cavity. The 430 Torque High-Speed handpiece Series can be assembled to quick disconnect couplers that are ISO Type 3 and ISO Type 2 connections, available as fiber optic or non-fiber optic versions, using a halogen bulb or LED technology. All couplers are autoclavable with the exception of the LED coupler that incorporates the electronics internally.
This looks like a 510(k) summary for a dental handpiece, and not a study on a medical device that uses artificial intelligence or machine learning. Therefore, most of the requested information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, MRMC studies) is not applicable.
However, I can extract the relevant performance data and mention the standards used for testing.
1. Table of Acceptance Criteria and Reported Device Performance
For dental handpieces, the "acceptance criteria" are generally compliance with recognized consensus standards for safety and performance. The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format, but rather demonstrates compliance with a standard and compares performance metrics to predicate devices.
| Characteristic | Acceptance Standard / Predicate Range | Reported Device Performance (430 Torque High-Speed Handpiece Series) |
|---|---|---|
| Performance Standard | ISO 7785-1 (for predicates) | ISO 14457:2012 Dentistry – Handpieces and motors (for proposed device) |
| Rotational Speed (no load) | 430,000 rpms (at 30-34 PSI) | 350,000 to 450,000 rpms (at 38-43 PSI) |
| Power | 14 watts (on average) | Up to 20 watts (on average) |
| Stall Torque | 0.181 oz.-in. | 0.269 oz.-in. |
| Sterilization Standard | AAMI TIR No. 12-1994, FDA June 1996 guidance document | ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, ANSI/AAMI ST81:2004 (R2010) |
| Biocompatibility | Known biocompatible materials (400/300 series stainless steel) | Identical material composition and manufacturing process to predicates (stainless steel, aluminum) |
| Risk Analysis Standard | ISO14971:2012 | ISO14971:2012 Medical devices - Application of risk management to medical devices (for proposed device and current for predicates) |
Notes on the Table:
- The proposed device (430 Torque High-Speed Handpiece Series) demonstrates improved performance (higher power, higher rotational speed, higher stall torque) compared to its predicates, while still being considered substantially equivalent.
- The "acceptance criteria" are implied by meeting or exceeding the performance of the predicate devices and complying with relevant international standards for safety and performance (e.g., sterilization, risk management, performance standards for dental handpieces).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance testing ... in accordance with ISO 14457:2012 Dentistry – Handpieces and motors" and "Sterilization validation...". These are bench tests, and the sample size or specific data provenance (country, retrospective/prospective) are not detailed within this 510(k) summary. Given the nature of a 510(k) submission for a mechanical device, the data would typically be generated during product development and testing, likely by the manufacturer, Dentalez, Inc. (USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a mechanical dental device and not an AI/ML diagnostic or prognostic device requiring expert ground truth for image or data interpretation. The "ground truth" for this device's performance is established through objective physical measurements according to specified ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as point 3.
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 as this is a mechanical dental device and not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as this is a mechanical dental device and not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is objective physical measurements (e.g., rotational speed, power, stall torque) and compliance with recognized consensus standards (e.g., ISO 14457:2012 for performance, ANSI/AAMI ST79:2010 for sterilization, ISO 14971:2012 for risk analysis).
8. The sample size for the training set
This is not applicable as this is a mechanical dental device and does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This is not applicable as this is a mechanical dental device and does not involve a "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.