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Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit. The electrical drive, EM-12 L is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The W&H electric motor EM-12 L is designed to accommodate existing and new handpiece attachments (already cleared for market under K070663 and K162926) for the purpose of performing dental procedures as described above. The advantage to driving a handpiece with this electro motor is the adjustable speed and near-constant torque applied by the electric brushless micro motor. The system will be used in an integrated configuration on the dental operatory chair system. The motor controller is contained within the control head (Dental unit) and acquires +24 VAC from the chair system 300 W power supply secondary voltage output. The motor tubing extends from the motor controller inside the control head to the micro-motor with ISO-E-coupler suitable to a handpiece attachment for the intended dental procedure. The Electric Handpiece Motor is to be installed in A-dec dental operative units. The power/CAN-Bus will be provided by the dental unit controller board and connected to the controller.

The provided text describes the 510(k) premarket notification for the "Electric Handpiece Motor EM-12 L". It focuses on establishing substantial equivalence to a predicate device and details non-clinical testing. It explicitly states that clinical performance testing was NOT conducted. Therefore, there is no study described that proves the device meets acceptance criteria related to clinical performance. The acceptance criteria and "device performance" in this context refer to the successful completion of non-clinical tests and the device's adherence to relevant standards, not clinical efficacy or diagnostic accuracy.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for each non-clinical test. The testing was performed on the device itself and its components.
• Data Provenance: The tests were conducted internally by the manufacturer (W&H Dentalwerk Bürmoos GmbH) or by accredited labs on their behalf, adhering to international and FDA standards. The country of origin is Austria (manufacturer location). This is retrospective data regarding the device's design and manufacturing.

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

• Not applicable. The ground truth for these non-clinical tests is established by the specified international standards (e.g., IEC 60601, ISO 14457, ISO 10993) and FDA guidance documents. Compliance with these standards indicates the "ground truth" of safety and performance for this type of device in a regulatory context. There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.

4. Adjudication method for the test set

• Not applicable for non-clinical engineering and safety tests. The "adjudication" is whether the device's performance characteristics (e.g., electrical safety, EMC emissions, torque, temperature) meet the predefined limits and requirements set forth in the relevant standards.

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 a dental handpiece motor, not an AI or imaging device that would involve human readers or MRMC studies.

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

• No. This is a physical medical device (dental handpiece motor), not an algorithm. Performance assessment is based on physical and electrical characteristics against predefined engineering and safety standards.

7. The type of ground truth used

• The ground truth used for these non-clinical tests is compliance with established international and national standards, regulations, and validated test methodologies. For example, for Electrical Safety, the ground truth is defined by IEC 60601-1. For biocompatibility, it's ISO 10993.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.

The A-dec/W&H Electric Motel EA-53 is designed to accommodate existing and new Alegra, Proxeo, Endea, and Synea handpiece attachments for the purpose of performing dental restoration procedures. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. The significant advantage to driving a handpiece with the electric micromotor is the near-constant torque applied by the electric brushless micromotor. With air motor drive, the handpiece will tend to stall in extreme torque situations. The near-constant torque applied by the electric micromotor results in a more uniform and efficient dental reduction of the operatory site. The electric micromotor is autoclavable. This system will be used in an integrated configuration on the dental operatory chair system. The motor controller is contained within the control head (dental unit) and acquires +24 VAC from the chair system 300W power supply secondary voltage output. The handpiece tubing extends from the control head to the ISO-E coupler. The micromotor is attached to the coupler on one end and attached on the other (output) end to a handpiece attachment suitable for the intended dental procedure. This system will include: Motor Controller, Electric Micromotor, Handpiece tubing with E-connector.

The provided text describes a 510(k) premarket notification for the A-dec/W&H Electric Motor, Model EA-53. However, it explicitly states that clinical testing has not been conducted for this product. Therefore, no studies proving the device meets acceptance criteria via clinical performance data are available in this document.

The submission focuses on demonstrating substantial equivalence to a predicate device (A-dec/W&H Electric Motor, Model EA-50LT) based on technological characteristics and non-clinical test data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) are reported for clinical performance, as clinical testing was not performed. The non-clinical tests focused on functional and safety parameters.

The document states, "The A-dec/W&H Electric Motor, Model EA-53 has been successfully validated to confirm the performance of the device," for all listed non-clinical tests. However, the exact pass/fail criteria or quantitative results for these validations are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable for clinical performance, as no clinical testing was conducted. For non-clinical tests (e.g., EMC, electrical safety), the sample size of tested devices is not specified, but typically involves a limited number of production units.
• Data Provenance: Not applicable for clinical performance. For non-clinical tests, the data would be generated internally by the manufacturer or by a contracted testing facility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical ground truth was established due to the absence of clinical testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported, as there was no clinical testing involving human readers or AI assistance.

6. Standalone Performance Study

No standalone performance study (algorithm only) was conducted or reported, as the device is a mechanical/electrical dental motor, not an AI algorithm.

7. Type of Ground Truth Used

• Clinical Ground Truth: Not applicable, as no clinical testing was performed.
• Non-Clinical Ground Truth: For the non-clinical tests, the "ground truth" would be defined by the relevant consensus standards (e.g., for electrical safety, EMC) against which the device's performance was measured. In essence, the standard is the ground truth.

8. Sample Size for the Training Set

Not applicable. The device is a physical product (electric motor) and does not involve AI or machine learning that requires a "training set" of data in the conventional sense. Its functionality is based on established engineering principles and mechanical/electrical design.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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