Search Results

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.

Ask a specific question about this device