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The G7 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.

The G7 dental chair with operative unit is a dental chair with an operative unit attached for patient to sit during the dental diagnosis, treatment and /or operation. The dental chair has adjustable headrest, backrest, seat height and armrests. The proposed device also consists of dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon), dental light and foot control. The instrument holder includes a 3-way syringe and salvia ejector supplied by DCI which are cleared by FDA (K151987).

The provided text is a 510(k) Summary for a dental operative unit, the G7. This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device's performance against specific acceptance criteria for a novel AI/software function.

Therefore, the document does not contain the information requested regarding acceptance criteria and the detailed study that proves the device meets those criteria, specifically concerning advanced AI/software performance. The device mentioned (G7, Dental Operative Unit and Accessories) is a physical piece of medical equipment, not an AI-driven diagnostic or assistive tool.

The "Software Verification and Validation Testing" section on page 10 refers to firmware for controlling the dental chair, which is typical embedded software for device operation, not AI. The "moderate" level of concern mentioned is related to the potential impact of software failure on device function, not on diagnostic accuracy of an AI.

To directly answer your request based on the provided text:

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

• Not Applicable. The document does not describe acceptance criteria for an AI/software performance study in the manner requested (e.g., sensitivity, specificity, AUC). It discusses compliance with general safety and performance standards for a dental operative unit.

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

• Not Applicable. There is no "test set" in the context of an AI performance study. The testing refers to engineering and electrical safety compliance.

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 AI performance, is not established for this type of device and its described testing.

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

• Not Applicable. This is not an AI performance study requiring adjudication of interpretations.

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 document covers a dental operative unit, not an AI-assistive diagnostic tool. No MRMC study was performed or is relevant to this device's regulatory review based on the provided information.

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

• Not Applicable. The device is a physical dental unit, not a standalone algorithm.

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

• Not Applicable. Ground truth in the context of AI diagnostic performance is not relevant here. The "ground truth" for the device's performance relates to compliance with engineering and safety standards (e.g., voltage measurements, material properties, mechanical function).

8. The sample size for the training set:

• Not Applicable. This device does not involve a "training set" for an AI model.

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

• Not Applicable. No training set exists for this device.

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The A-dec NLZ electric motor system is control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, prophylaxis and endodontic treatment, with use of a straight, right-angle ISO E-tvpe handpiece attachment of equal, gear-reducing, or gear-increasing speed.

The A-dec NLZ electric motor system 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, gear-reducing, or gear-increasing speed.

Control Unit, Motor and Motor Tubing are constituents of the A-dec NLZ electric motor system under this 510(k) application. The A-dec NLZ electric motor system is intended for use only with the A-dec 300 (K082985) or A-dec 500 (K032756) delivery system. The A-dec 300 (K082985) or A-dec 500 (K032756) delivery system offers operation modes for use with the A-dec NLZ electric motor system.

The Control Unit of the A-dec NLZ electric motor system is contained within the control head of the A-dec 300 (K082985) or A-dec 500 (K032756). The subject device acquires +24 VAC electrical power from the delivery system to the Control Unit. User can control the motor system through Touch Pad and Foot Controller of the delivery system. The control unit receives instructions such as motor rotation/stop, speed setting value, torque setting value, and LED turning ON/OFF from Touch Pad and Foot Controller. The Control Unit drives the Motor using instructed rotation speed and torque via Motor Tubing. The delivery system provides standard mode (range of rotation speed is 1,000 - 40,000 rpm) and endo mode (range of rotation speed is 100 - 5,000 rpm).

The Motor Tubing is connected to the Control Unit via a lead wire and air/water supply via tubing inside the control head of the delivery system. The other side of the Motor Tubing is attached to the Motor.

The provided document is a 510(k) summary for the A-dec NLZ Electric Motor System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the level of detail typically required to answer your specific questions regarding acceptance criteria and a detailed study proving performance, especially in the context of AI/ML devices or studies involving human readers and ground truth.

This document describes a traditional dental device (electric motor system), not an AI/ML device. Therefore, many of your questions, particularly those about AI/ML specific details like training sets, ground truth establishment for training data, MRMC studies, or standalone algorithm performance, are not applicable to the information provided.

Based on the available information, here's what can be extracted and what cannot:

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

The document states that the device was compliant with ISO 14457 and met the requirements of other standards. However, it does not provide a table with specific acceptance criteria (e.g., numerical thresholds for different performance metrics) and corresponding reported performance values for those criteria. It only provides a comparison table of features and ranges with the predicate device.

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

The document mentions "All A-dec NLZ electric motor system samples" for bench testing but does not specify a numerical sample size. It refers to "samples" being compliant, but no specific count is provided. There is no information about data provenance as this is a device performance test, not a data-driven clinical study.

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

Not applicable. This device is not an AI/ML product that would require expert-established ground truth for a test set in the same way. The "ground truth" for this device's performance would be objective measurements against engineering and safety standards.

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

Not applicable. This concept applies to human expert review for establishing ground truth, which is not relevant here.

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 is not an AI-assisted device. No MRMC study was mentioned or implied.

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

Not applicable. This is not an algorithm, but a physical electric motor system.

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

For the performance tests mentioned (bench testing, electrical safety, EMC, biocompatibility, backflow, extractables), the "ground truth" is established by the specified international and national standards (e.g., ISO 14457, IEC 60601-1, IEC 60601-1-2, ISO 10993 series) and FDA guidance documents. Compliance is determined by objective measurements meeting the criteria set forth in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a "training set."

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

Not applicable. This is not an AI/ML device.

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