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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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