(101 days)
The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.
Endo 6:1 is a contra-angle handpiece which is adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable and it does not have a fiber optic light system.
T1 LINE ENDO 6 L contra-angle handpiece is equipped with a fiber optic light system. It is also adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable.
SIRONiTi APEX contra-angle handpiece is adapted to dental electric motors with the ISO 3964 interface. It is reusable. SIRONiTi APEX is equipped with a torque limitation function. Once a set torque has been reached, a gold plated magnetic coupling prevents jamming of the file in the root canal by retro-rotation.
T1 Spray is the lubricant used for maintenance and cleaning of the drive channels of the handpieces.
The provided text is a 510(k) Summary for dental handpieces. This document focuses on demonstrating substantial equivalence to predicate devices based on design, function, and performance standards, rather than proving a device meets specific acceptance criteria based on clinical study performance of an AI-powered device.
Therefore, many of the requested categories for AI/clinical study performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to the information contained in this type of submission.
The document does not describe the acceptance criteria and a study proving the device meets those criteria in the context of an AI-powered medical device and its performance against a specific clinical outcome. Instead, it demonstrates compliance with recognized performance standards for dental handpieces.
However, I can extract the relevant information regarding the performance standards and a general conclusion of equivalency:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO 14457:2012-09-15 Dentistry Handpieces And Motors | Complies |
| ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management system | Complies |
| ISO 7405:2008-12-15 Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)] | Complies |
| ISO 14971:2007-03-01 Medical Devices - Application Of Risk Management To Medical Devices | Complies |
| ISO 15223-1:2012-07-01 Medical Devices - Symbols To Be Used With Medical Device Labels, Labeling, And Information To Be Supplied - Part 1: General Requirements | Complies |
| AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities | Complies |
| DIN EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | Complies |
| ISO 10993-10:2010-08-01 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | Complies |
| EN ISO 13485:2003 Medical devices Quality management systems -- Requirements for regulatory purposes | Complies |
| DIN EN ISO 17664:2004 – Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices | Complies |
| DIN EN ISO 21531:2009 – Dentistry -- Graphical symbols for dental instruments | Complies |
| ISO 3964:1982 - Dental handpieces – Coupling dimensions | Complies |
2. Sample size used for the test set and the data provenance:
- Not applicable for a 510(k) submission of this type of device. The compliance is based on meeting engineering and biocompatibility standards, not on clinical performance evaluations with a specific test set of patients/data. The "study" mentioned is conformity to existing standards, which implicitly involves testing the device against those standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of clinical performance is not established here. The document mentions "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed," but this is for overall assessment, not for establishing ground truth on a specific test set for an AI algorithm.
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:
- No. This is not an AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of device, "ground truth" relates to the device successfully meeting the specifications outlined in the various ISO/DIN/AAMI standards (e.g., sterilization effectiveness, biocompatibility, mechanical performance as per ISO 14457).
8. The sample size for the training set:
- Not applicable. This is not an AI-powered device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI-powered device.
Summary of the study that proves the device meets the acceptance criteria (from the text):
The device's performance is demonstrated through its compliance with a list of recognized national and international performance standards (listed in the table above). These standards cover aspects such as mechanical performance, biocompatibility, risk management, sterilization, labeling symbols, and quality management systems. The document states: "The Sirona Dental System T1 LINE Endo 6 L, ENDO 6:1 and SIRONiTi Apex contra-angle handpieces comply with the following performance standards." Additionally, "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed." This implies that testing and evaluation against these standards were conducted to ensure the devices meet the specified requirements for safety and performance. The conclusion drawn is that "Based on a comparison of intended use, indications, principal of operations, features and technical data, the Sirona Dental Systems T1 LINE ENDO 6 L, ENDO 6:1 and SIRONiTi APEX are similar in design and function to the Predicate Devices. Therefore, the subject device is substantially equivalent to the 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.