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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 NLZ Motor System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.

The NLZ Endo is intended for use by dental professionals in the performance of dental endodontic procedures.

NLZ Motor Systems are available in two models;

NLZ Motor Set, which consists of the Main Unit, the Control Unit and the Motor.

NLZ E Motor Set, which consists of the Main Unit, the Control Unit, the Motor, and the Contra Angle Handpiece: NLZ Endo. The NLZ Endo is available only for NLZ E Motor Set and is not avialable for the NLZ Motor Set. The NLZ Endo is not equipped with any cooling system because it is a speed-reducing/low-speed handpiece.

The Control Unit drives an electric micromotor, and turns on off or regulates the speed of an electric motor by its foot pedal of the dental unit. This product can be connected to dental units currently in use to add on a brushless electric micromotor with an LED light.

The provided text describes Nakanishi Inc.'s NLZ Motor System and its substantial equivalence to predicate devices, focusing on various performance aspects. However, the document does not present acceptance criteria in a table format with specific quantitative targets and corresponding device performance measurements. Instead, it discusses compliance with general standards and the satisfactory outcome of various tests.

Here's an analysis based on the available information, addressing as many of your points as possible:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly provide a table of acceptance criteria with numerical performance targets and reported values for the NLZ Motor System. Instead, it states that the device was compliant with various ISO and IEC standards. The "performance" is generally described as "met all requirements" or "do not raise concern."

However, specific comparisons are made with predicate devices, which can infer performance expectations. For instance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified. The document mentions "All samples were compliant with ISO 14457:2012" and "This testing is verification test for software by putting excessive load to the Motor." However, the exact number of devices tested for each criterion is not provided.
• Data provenance: Bench testing was performed internally by Nakanishi Inc. ("in-house standard," "bench testing was performed in order to verify conformity," "reprocessing validation was performed"). The document does not indicate the country of origin of the data beyond the company's location (Japan) and general compliance with international standards (ISO, IEC, AAMI, ANSI). The studies were retrospective as they describe testing conducted before submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing described is primarily technical bench testing and compliance with standards, not studies involving human experts establishing ground truth for diagnostic or clinical accuracy.

4. Adjudication method for the test set:

This information is not provided as the studies are technical performance and compliance tests rather than clinical evaluations requiring adjudication of subjective outcomes.

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 MRMC comparative effectiveness study was done or is mentioned. This device is a dental motor system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not involve an algorithm for diagnostic or clinical interpretation that would operate in a standalone manner. The "overheating risk reduction functions" are automated features within the device, whose performance was verified through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance testing, the "ground truth" was defined by:

• International standards: ISO 14457, ANSI/AAMI/ISO 10993, IEC 60601-1-2, AAMI / ANSI/ES60601-1, AAMI TIR 12, AAMI TIR 30, and FDA Reprocessing guidance.
• In-house standards: For the overheating risk reduction features.
• Predicate devices: The performance characteristics of the NLZ Motor System were compared to those of the predicate devices for establishing substantial equivalence.

8. The sample size for the training set:

Not applicable. This device does not utilize a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no mention of a training set.

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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:

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."

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