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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:

1. long version (long) available in two variants: with white Led light, or with white and UV LED light; the long version is especially suitable for implant & endodontic procedures:
2. short version (short) available in three variants: without any incorporated LED, with optional white Led light, or with white and UV LEDs; the short version is 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:
3. CEFLA Dental Unit, legally marketed in USA, through a cord for connection between micromotor and the dental unit system including electronic board;
4. handpieces which transmit movement to their tips or other instrument, legally marketed in USA.
   The near-UV LED light is limited to visualization of dental composites with limited exposure time (i.e., observation of the margin of the composite and tooth structure). The near-UV LED light is not intended for use during rotation of the handpiece.

The provided text is a 510(k) Summary for a dental device (micromotors). It describes the device, its intended use, and compares it to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance evaluation. It focuses on non-clinical performance testing (electrical safety, EMC, photobiological safety) and states that clinical performance testing was not conducted.

Therefore, I cannot provide the requested information regarding AI/ML performance acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The closest relevant sections in the document discuss:

• Non-clinical Performance Testing (Page 18): This section lists various safety and compatibility tests carried out (Electrical safety, Electromagnetic compatibility, Photobiological safety). It states that other non-clinical performance tests were not repeated as the tests performed for the predicate device (K213022) are considered valid for the proposed variants.
• Clinical Testing (Page 18): Explicitly states, "Clinical performance testing was not conducted."
• Conclusion (Page 18): Asserts substantial equivalence based on similarities in intended use, principle of operation, functional design, and established medical use, with differences deemed minor and not negatively affecting substantial equivalence.

In summary, the provided document does not describe the kind of AI/ML performance study, acceptance criteria, or related details that your request asks for. This device is a dental micromotor, not an AI/ML-driven diagnostic or therapeutic device.

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