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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) with Led light, especially suitable for implant & endodontic procedures;
2. 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:
3. CEFLA Dental Unit, legally marketed in USA, thought 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.

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.

Study Details (based on the provided document):

1. 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.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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."
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. 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).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.

The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows: Z95L 1:5 Increasing, Z85L 1:5 Increasing, Z25L 1:1 Direct Drive, Z15L 4:1 Reducing, Z10L 16:1 Reducing. The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area. The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019. The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece. The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.

The provided document is a 510(k) premarket notification for a dental handpiece. It describes modifications to an existing device and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain the detailed information necessary to answer all parts of your request, which primarily focuses on clinical study data, acceptance criteria related to performance metrics, and human-in-the-loop assessments for AI/ML devices.

This document is for a Class I dental handpiece, which is a physical mechanical device, not an AI/ML powered device that would typically involve acceptance criteria like accuracy, sensitivity, specificity, or studies with expert adjudications and MRMC designs.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted (and interpreted for context):

The document primarily focuses on demonstrating substantial equivalence for a modified physical medical device (a dental handpiece) to a previously cleared predicate device. For such devices, acceptance criteria often revolve around engineering performance, material compatibility, and safety standards rather than clinical performance metrics like those for AI/ML.

1. A table of acceptance criteria and the reported device performance

The document mentions "applicable technical standards, internal specifications, and FDA guidance documents" were used. It also states:

What cannot be answered from the provided text:

The following points are typically relevant to AI/ML or diagnostic devices that rely on data for performance metrics (e.g., sensitivity, specificity, AUC). Since this document is for a physical dental handpiece, these concepts don't directly apply in the way you've framed them.

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for a mechanical device would involve engineering tests (e.g., torque, speed, durability, material testing) rather than a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" in the clinical data sense for a mechanical device's direct performance. Adherence to engineering specifications and safety standards are the benchmarks.
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 device is not an AI/ML diagnostic tool.
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/ML algorithm. For this device, the "ground truth" for performance would be established engineering specifications, material standards, and safety requirements.
8. The sample size for the training set: Not applicable. There is no "training set" for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

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