(329 days)
Pneumatic drive system for dental handpieces and dental air motors, which is intended to be used in general dental applications such as: removal of decayed materials, cavities and crown preparations, removal of filings, finishing of tooth and restauration surfaces, polishing, prophylaxis and endodontics.
The Advanced Air System is intended for dental transmission instruments used in the field of preventive dentistry, restorative dentistry such as cavity preparation and prosthodontics such as crown preparation and endodontics.
The system consists of the control unit (AC-1.0), which is designed to be built in a dental chair. As an attachment the air-driven handpiece (RK-97 L, RG- 97 L, and/or RK-94 L) or the air motor (RM-25 L RM) can be used.
The air-driven handpiece is equipped with a speed sensor, which is connected to a control module that regulates the applied air pressure to the handpiece through a proportional valve in order to maintain constant speed throughout the dental treatment.
This document describes a 510(k) premarket notification for the "Advanced Air System" device. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical acceptance criteria for new therapeutic or diagnostic claims. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, expert ground truth, and statistical performance metrics (like those used for AI/ML devices) is not directly applicable or available in this document.
However, I can extract information related to the device's technical specifications and the non-clinical performance testing conducted to support its substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in the sense of clinical performance thresholds (e.g., sensitivity, specificity, or therapeutic efficacy rates). Instead, it establishes substantial equivalence based on a comparison of technological characteristics and adherence to recognized standards.
Technological Characteristics Comparison (Subject Device vs. Predicate Device)
| Characteristic | Subject Device (Advanced Air System Control Unit) | Primary Predicate Device (Axis System K072989) | Reference Predicate Devices (Handpieces/Motors K070663, K082716) (Specific Model) | Notes on Comparison & Performance |
|---|---|---|---|---|
| Control Unit Features | ||||
| User modes (control characteristics) | 3 | 1 | The subject device offers more user modes. This is presented as an enhancement, not a failure to meet criteria. | |
| Supply air | 0.52 – 0.59 MPa (75 – 85 psi) | 0.45 – 0.52 MPa (65 – 75 psi) | Differences in operating air pressure. Assumed to be within safe and functional ranges for dental applications. | |
| Power supply | 19–29 V AC @ 50-60Hz or 24-40 V DC | 24 V DC | Differences in power supply range. Assumed to be safe and compatible with typical dental operatory setups. | |
| Speed Sensor Location | Head area (direct measurement of rotation) | Coupling area (measures vibration) | Technological difference, with the subject device offering more direct speed measurement. This is presented as an equivalent or improved method. | |
| Handpiece/Motor Features | ||||
| Optic lighting | yes | yes (TA-97 LED, AM-25 L RM) | Equivalent. | |
| Speed range (RK/RG-97 L) | 60,000–320,000 rpm | 400,000 rpm (TA-97 LED) | Subject device has a slightly lower maximum speed range than TA-97 LED, but within acceptable range for its intended use. | |
| Speed range (RK-94 L) | 60,000–320,000 rpm | (no direct comparable predicate for this model listed for speed) | ||
| Speed range (RM-25 L RM) | 2,000-20,000 rpm | 5,000–25,000 rpm (AM-25 L RM) | Subject device has a slightly wider low-end speed range. | |
| Max. torque (RK/RG-97 L) | 2.4 Nmm (0.34 ozf in) | 1.7 Nmm (0.25 ozf in) (TA-97 LED) | Subject device has higher torque. | |
| Max. torque (RK-94 L) | 1.5 Nmm (0.21 ozf in) | |||
| Max. torque (RM-25 L RM) | 4.4 Nmm (6.2 ozf in) | 24 Nmm (3.4 ozf in) (AM-25 L RM) | Subject AM-25 L RM has significantly lower max torque than the predicate AM-25 L RM. This could be a point of divergence if the application area required the higher torque. However, the submission implies it's still equivalent for general dental applications. | |
| Max. power (RK/RG-97 L) | 30 W | 18 W (TA-97 LED) | Subject device has higher power. | |
| Max. power (RK-94 L) | 20 W | |||
| Max. power (RM-25 L RM) | 28 W | 16 W (AM-25 L RM) | Subject device has higher power. | |
| Torque limit | 30 - 100 % (available) | None (for predicates specified) | Subject device offers a feature that the predicate may not have. Not a failure criterion. | |
| Max. air consumption (RK/RG-97 L) | 1.2 l/s (2.5 cfm) | 0.75 l/s (1.5 cfm) (TA-97 LED) | Subject device consumes more air. | |
| Max. air consumption (RK-94 L) | 1.1 l/s (2.3 cfm) | |||
| Max. air consumption (RM-25 L RM) | 1.5 l/s (3.2 cfm) | 1 l/s (2.1 cfm) (AM-25 L RM) | Subject device consumes more air. | |
| Weight (RK/RG-97 L) | 38 g (1.34 oz) | 38 g (1.34 oz) (TA-97 LED) | Equivalent. |
The report concludes that the "differences between the devices shown in the side-by-side comparison table above are minor and do not have any negative effect on equivalence."
2. Sample sized 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. The performance testing described is primarily non-clinical, involving engineering and biocompatibility evaluations, not data from a test set of clinical cases.
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)
Not applicable. This device is a dental handpiece system, and its approval relies on technical specifications and non-clinical performance, not expert-adjudicated ground truth as would be required for a diagnostic or AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance is adherence to recognized engineering standards and comparison to a legally marketed predicate device's technical specifications and performance.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):
The "study" proving the device meets the "acceptance criteria" (defined here as demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards) consists of a series of non-clinical tests:
- Electrical Safety Tests: According to IEC 60601-1:2005.
- Electromagnetic Compatibility (EMC) Test: According to IEC 60601-1-1:2007.
- Product Testing of Handpiece Function and Life Cycle Testing: Per ISO 14457:2012 (Dentistry - Handpieces and Motors).
- Software Validation: According to IEC 62304:2006 (Medical device software).
- Usability Validation: According to IEC 62366:2007.
- Thermal Safety: According to IEC 62471:2006 (Photobiological safety of lamps and lamp systems).
- Biocompatibility Evaluation: Based on identical patient-contacting materials with previously cleared W&H handpieces (TA-97LED and AM-25L RM) and Cytotoxicity Testing per EN ISO 10993-5:2009-06. This evaluation meets ISO 7405:2008.
The document states, "The results demonstrate substantial equivalence in this regard" for the product testing. No clinical data was deemed necessary for this submission. The overall conclusion is that "The “Advanced Air System”, as designed and manufactured, is substantially equivalent to its predicate device."
§ 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.