(231 days)
The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units.
They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.
They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.
The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.
The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.
The CEFLA Dental Micromotors family presents two versions:
- long version (long) with Led light, especially suitable for implant & endodontic procedures;
- short version (short) with optional Led light, especially suitable for prosthetic & restorative procedures.
Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques.
Furthermore, both versions of micro-motors are intended to be connect with the following two parts: - CEFLA Dental Unit, legally marketed in USA, thought a cord for connection between micromotor and the dental unit system including electronic board;
- handpieces which transmit movement to their tips or other instrument, legally marketed in USA.
This document is for Premarket Notification (510(k)) and pertains to dental micromotors, not an AI/ML powered medical device. Therefore, the information requested in points 1-9 regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not explicitly available in this submission.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing relevant to the physical device.
However, I can extract information regarding non-clinical performance testing that serves as "acceptance criteria" for this specific medical device, as well as the types of studies conducted to show it meets those criteria:
Non-Clinical Performance Testing (Acceptance Criteria & Reported Performance):
The submission states that various non-clinical tests were conducted and proved the device met the relevant standards. While specific numerical acceptance criteria values are not provided, the "Meets" status implies successful completion against the requirements of the listed standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Study Conducted) |
|---|---|
| Electrical safety (IEC 60601-1) | Test was conducted and performed in accordance with IEC 60601-1. |
| Electromagnetic compatibility (IEC 60601-1-2) | Test was conducted and performed in accordance with IEC 60601-1-2. |
| Usability (IEC 60601-1-2 & IEC 62366) | Usability test was conducted in accordance to IEC 60601-1-2. Application of usability engineering was conducted in accordance to IEC 62366. |
| Mechanical Performance (ISO 14457) | Mechanical Performance and cooling flows and Visual inspection were conducted in accordance to ISO 14457. |
| Biocompatibility (ISO 10993-1 & ISO 10993-5) | Evaluation of biocompatibility is based on ISO 10993-1 and ISO 10993-5. |
| Reprocessing Validation (FDA Guidance) | Validation of the reprocessing according "FDA guidance Reprocessing Medical Devices Health Care Settings: Validation Methods and Labeling." |
| Sterility after reprocessing (ISO 11737-2) | Evaluation of sterility test after reprocessing is based on ISO 11737-2. |
Study Details (based on the provided document):
- Sample size used for the test set and the data provenance: Not applicable. These are non-clinical hardware performance tests, not AI/ML model evaluations requiring test sets of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and performance tests against established standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a physical device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical Testing: Clinical performance testing was not conducted."
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests are the established, quantifiable requirements and limits set forth in the referenced international standards (e.g., IEC 60601-1, ISO 14457).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML 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.