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The NLZ Built-in Motor System is indicated for use in the field of prophylaxis dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The NLZ Built-in Motor System is a dental treatment system that is integrated and used in conjunction with dental chair units. It is composed of a motor system, a Multi-Pad, as well as a handpiece (optional) and cord that are compatible with different electric attachments The motor system has a control unit that works as an electric micromotor which can turn on or off and regulates the speed of the electric motor by the 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. Depending on the specifications of each chair unit manufacturers, the combination and operation method of the NLZ Built-in Motor System board, harness, and operation method will change.

This is a 510(k) summary for a dental handpiece and accessories, the NLZ Built-In Motor System. It outlines the regulatory process for marketing the device and demonstrates substantial equivalence to predicate devices, but does not describe or include details of an acceptance criteria table or specific studies that show the device meets acceptance criteria related to an AI device's performance.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them, as the provided text pertains to a traditional medical device (a dental handpiece motor system) and its regulatory clearance process, not an AI/ML-enabled device. The document focuses on demonstrating the device's substantial equivalence through non-clinical performance and biocompatibility testing against established standards for dental medical devices.

Specifically, the document does not contain any of the following information relevant to an AI/ML device performance study:

• A table of acceptance criteria and reported device performance: No such table exists for AI performance metrics.
• Sample size for the test set and data provenance: No test set of data for an algorithm is mentioned.
• Number of experts used to establish ground truth and their qualifications: No expert review for ground truth is discussed.
• Adjudication method for the test set: Not applicable in this context.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: The device is a physical dental motor system, not a standalone algorithm.
• Type of ground truth used: Not applicable for this type of device.
• Sample size for the training set: There is no AI model to train.
• How ground truth for the training set was established: Not applicable.

The performance testing listed focuses on:

• Motor performance
• Reprocessing (sterilization)
• Software (life cycle processes, which is about development and maintenance, not AI performance)
• Electrical safety
• Electromagnetic compatibility (EMC)
• Biocompatibility

These are standard non-clinical tests for physical medical devices to ensure safety and functionality, not AI performance.

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