(90 days)
The SiroTorque L is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces.
The SiroTorque L is composed of a supply / control unit, supply hoses, connection cables, a transformer and two alternative electric micromotors. The pneumatic outlet from the dental treatment unit, which would be the supply hose for an air-driven instrument (e.g., a high speed handpiece or an air motor), provides the input to the SiroTorque L supply / control unit. The electronic circuitry within the SiroTorque L converts the air pressure input to an electrical signal, which is output to the supply hose for the handpiece electric micromotor. The handpiece electric micromotor is activated using the footswitch of the existing dental operative unit. As the footswitch is pressed farther down, the pressure of the compressed air supply increases, which in turn increases the rotational speed of the micromotor. The permissible speed range is adjustable by the user from 1,000 to 40,000 rpm, although the highest speeds are only attainable if the compressed air supply has a pressure of at least 3 bars. The minimum and maximum speeds are displayed and can be adjusted using the SiroTorque L control panel. The SiroTorque L also provides the user with the following features: Selection of clockwise and counter-clockwise rotation of the dental handpieces, Variable intensity handpiece light, "Satellite" version: The control panel of the SiroTorque L can be separated from the supply / control unit and mounted so as to be more easily accessible for the user.
The provided 510(k) summary for the Sirona Dental Systems SiroTorque L is for a dental handpiece and accessories controller unit, not an AI/ML powered device. Therefore, much of the requested information regarding AI device acceptance criteria and performance evaluation (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance) is not applicable to this document.
However, I can extract the information that is present and relevant to device performance and substantiation.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Performance Aspect | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence | "substantially equivalent to the Bell International Mark 20 and Mark 25 Hand Engine Controller based on equivalence of the intended uses" |
| Technical Characteristics Equivalence | "substantially equivalent to the Bell International Mark 20 and Mark 25 Hand Engine Controller based on equivalence of...technical characteristics." |
| Safety and Effectiveness Validation | "Performance testing to validate the safety and effectiveness of the SiroTorque L included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions." |
| Pneumatic to Electrical Conversion | Converts pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. |
| Speed Range | Adjustable by the user from 1,000 to 40,000 rpm. Note: Highest speeds only attainable with compressed air supply of at least 3 bars. |
| Rotation Selection | Provides selection of clockwise and counter-clockwise rotation of the dental handpieces. |
| Handpiece Light | Provides variable intensity handpiece light. |
| Control Panel Flexibility | "Satellite" version allows the control panel to be separated from the supply/control unit and mounted for easier user access. |
Missing/Not Applicable Information (as per AI device context):
Due to the nature of this device (a physical controller for dental handpieces), the following requested information is not relevant or present in the provided 510(k) summary:
- 2. Sample size used for the test set and the data provenance: Not an AI device, so no "test set" of an AI algorithm. Performance testing would have involved physical device testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device functionality is physical, not based on expert-labeled data.
- 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. This is not an AI-assisted diagnostic or interpretative device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI device. "Ground truth" for this device would be its physical specifications and functionality meeting engineering standards.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of Device Substantiation:
The Sirona Dental Systems SiroTorque L gains its market clearance based on substantial equivalence to predicate devices (Bell International Mark 20 and Mark 25 Hand Engine Controller). The substantiation largely relies on the equivalence of its intended use and technical characteristics, supported by performance testing covering electrical safety, electromagnetic compatibility, and hardware/software function validation.
§ 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.