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The Surgic Pro2 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements.

The Surgic Pro2 is intended for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad.

• The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth.

The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.

The provided text is an FDA 510(k) summary for a dental device called "Surgic Pro2." It outlines the device's technical specifications, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The non-clinical tests mentioned are primarily related to general device performance, reprocessing, software life cycle (general, not AI-specific), electrical safety, EMC, and cybersecurity. There is no mention of an AI/ML component or any performance metrics like sensitivity, specificity, or AUC that would typically be associated with AI application acceptance criteria for diagnostic or assistive devices.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria and a study proving the device meets these criteria based on the provided text. The text does not describe such a study or an AI component.

To directly address your request given the provided text's limitations, here's what I can extract and what I cannot:

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

The document mentions validation and verification testing against various standards and guidance documents. These are the "acceptance criteria" for the general device performance and safety. The "reported device performance" is simply that the "results of the exit [sic] the requirements of the following standards and guidance."

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

• Not specified. The document does not provide details on the sample sizes for the performance tests, only lists the standards against which they were tested. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for these non-clinical tests.

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

• Not applicable/Not specified. For the non-clinical tests mentioned (e.g., electrical safety, sterilization), "ground truth" as it applies to clinical data review by experts is not relevant. The conformity to standards would be assessed through engineering and quality testing, not expert clinical review.

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

• Not applicable/Not specified. This is relevant for clinical studies with expert reviewers, not for the type of non-clinical device performance and safety testing described.

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 evidence of an MRMC study. The document describes a traditional 510(k) pathway for a dental handpiece system, focusing on substantial equivalence based on technical characteristics and non-clinical performance (safety, reprocessing, software lifecycle, etc.), not a comparative effectiveness study involving human readers or AI assistance.

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

• Not applicable. The device described (Surgic Pro2) is a dental surgical system with a micromotor, handpieces, and control unit. While it has software and Bluetooth connectivity (e.g., to display ISQ values from another device), it is not an AI/algorithm-only device for diagnosis or image analysis. Its software controls mechanical functions, not an independent interpretive algorithm.

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

• Not applicable/Compliance with standards. For the non-clinical tests performed, the "ground truth" is typically defined by the specified parameters and limits within the engineering standards (e.g., specific electrical leakage limits, torque values, sterilization parameters).

8. The sample size for the training set:

• Not applicable. This device is not described as having an AI/ML component that would require a training set.

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

• Not applicable. As above, no AI/ML training set is indicated.

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