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IMPLANTEO dental unit is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics.

ANTHOGYR has developed a dental unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices.

IMPLANTEO kit includes: Control unit, Peristaltic pump, Motor, Motor, Motor holder, Control pedal, Calibration module, Bag carner

Four adjustable parameters are displayed on a large size screen : Speed which adjustment takes into account the reduction value used, Torque, Pump flow rate and Contra angle reduction ratio

In order to cover all the possible uses of the motor, up to 3 different protocols can be programmed. Each protocol allows for implant fitting in 4 sequences: drilling, reaming, tapping and screwing.

The provided text describes a 510(k) summary for the IMPLANTEO dental unit, an implantology motor. It outlines the device's intended use and conformity to various voluntary FDA-recognized Consensus standards. However, it does not contain information about acceptance criteria, specific performance studies (like accuracy or efficacy trials), sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance through substantial equivalence to predicate devices and adherence to general medical device standards, rather than direct performance studies or comparative effectiveness specific to an AI/ML component.

Here's why the requested information cannot be extracted:

• Acceptance Criteria & Reported Device Performance: While the document lists standards the device conforms to (e.g., IEC 60601-1 for safety, ISO 11498 for dental handpieces), these are general safety and performance standards, not specific acceptance criteria with quantifiable performance metrics (like sensitivity, specificity, or accuracy) for an AI/ML model.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): The document does not describe any specific performance study designed to evaluate the device's functional performance in terms of clinical outcomes or diagnostic accuracy. It mentions that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar, but no direct performance study data is presented.
• Ground Truth: Since no performance study is described, there's no mention of how ground truth would have been established.
• Training Set & Ground Truth for Training: This information is not relevant as the document does not describe an AI/ML device.

In summary, the provided text is a regulatory submission for a traditional medical device (dental implantology motor) and does not involve AI/ML. As such, the detailed questions regarding acceptance criteria, study design, and ground truth establishment for AI/ML performance are not applicable to this document.

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