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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 SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electricalpowered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).

The request asks for a detailed description of acceptance criteria and the study proving the device meets these criteria. However, the provided document is a 510(k) premarket notification for a dental handpiece (SMARTmatic), which focuses on demonstrating substantial equivalence to a predicate device rather than on specific acceptance criteria and a detailed study proving performance against those criteria.

The document primarily highlights the substantial equivalence of the SMARTmatic handpieces to the MASTERmatic LUX handpieces (K143465) based on intended use, technological characteristics, and performance data. It relies on conformance to various ISO standards and a guiding document for dental handpieces. The document does not contain information on:

• A specific table of acceptance criteria with reported device performance against numerical targets.
• Sample sizes for a test set or data provenance (as it's not a clinical study on diagnostic accuracy).
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (as it's a mechanical device, not an AI algorithm).
• Sample size for a training set or how ground truth for a training set was established.

Therefore, many of the requested points cannot be extracted from this document as they are not relevant to a 510(k) submission for a dental handpiece.

However, I can extract information related to the performance data and "acceptance" from the perspective of substantial equivalence and adherence to recognized standards.

Here's the information that can be extracted and a clear indication of what is not present:

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

The document doesn't provide a table of acceptance criteria in the sense of specific numerical thresholds for performance metrics. Instead, it relies on conformance to international standards. The "Summary of the Technological Characteristics" table ([page 7] and [page 8]) compares the new device (SMARTmatic) to the predicate device (MASTERmatic LUX) across various design and technical specifications. The "acceptance criteria" here are effectively that the new device's characteristics are either the same as the predicate or, if different, that these differences do not raise new questions of safety or effectiveness, as demonstrated by non-clinical testing to relevant standards.

Summary of Technological Characteristics and Performance (as presented in the document):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• None stated directly. The document refers to "Performance bench testing according to international standards." This typically involves testing a defined number of device units or components, but the specific sample sizes are not provided in this summary.
• Data Provenance: Not explicitly stated, but the manufacturer is Kaltenbach & Voigt GmbH, based in Biberach, Germany. The tests are "Non-Clinical Test Data," indicating lab/bench testing, not data from human subjects. This would be considered prospective bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This information is for clinical studies or AI algorithm validation, not for a mechanical dental handpiece undergoing bench testing for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is for clinical studies/AI algorithm validation.

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 a mechanical dental handpiece, 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 is a mechanical device, not an algorithm. Bench testing was done for the device itself.

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

• For biocompatibility: Conformance to ISO 10993-1. The "ground truth" is that the materials used meet the specified biocompatibility standards.
• For mechanical performance (e.g., bur retention force, speed range, coupling dimensions): Conformance to relevant ISO standards (e.g., ISO 14457, ISO 1797-1, ISO 3964). The "ground truth" is whether the physical measurements and operational parameters of the device meet the requirements of these standards.
• For sterilization: Conformance to ISO 17665-1 and AAMI ANSI ST79. The "ground truth" is that the sterilization process specified for the device achieves the required sterility assurance levels.

8. The sample size for the training set

• Not applicable. This refers to AI/machine learning models.

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

• Not applicable. This refers to AI/machine learning models.

Summary of the Study (as described in the document):

The "study" described is a non-clinical performance bench testing program to demonstrate substantial equivalence to a legally marketed predicate device (MASTERmatic LUX K143465).

• Methodology: Performance bench testing according to international standards (listed below) and biocompatibility and sterilization studies.
• Standards utilized for performance verification:
  • ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors)
  • ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals)
  • ISO 7405 / ISO 10993-1 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry / Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system)
  • ISO 14457 (Dentistry - Handpieces and motors)
  • ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1)
  • AAMI ANSI ST79 (Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities)
  • Guidance for Industry and FDA Staff - Dental Handpieces - Premarket Notification [510(k)] Submissions.
• Conclusion: The tests demonstrated that despite some differences in technological characteristics (e.g., external vs. internal spray, presence/absence of fiber optics, speed range, specific chuck types, and minor dimensions), these differences do not raise new concerns regarding substantial equivalence to the predicate device. The SMARTmatic handpieces are deemed substantially equivalent based on intended use, indications, technological characteristics, principle of operation, features, and performance data derived from these non-clinical tests.
• Clinical Data: The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

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The Spirit Dental Operative Units are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit Dental Operative Units are intended for use by professional dental practitioners in providing treatment in a dental operatory.

The Spirit Dental Operative Units serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, foot control, and a junction box that houses a power supply and air/water regulators. Various Handpieces and accessories can be added to the Spirit Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them into the Sprit Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments.

The provided text is a 510(k) Summary for a dental operative unit, not a study describing AI device performance. Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

This document focuses on establishing "substantial equivalence" to a predicate device for regulatory approval, primarily through non-clinical testing and comparison of technical specifications, rather than presenting a performance study of a device against specific acceptance criteria in the way you've described for an AI-powered medical device.

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