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GMI Frontier Dental Implant System model is intended to be used for surgical placement in upper or lower jaw to provide a support for prosthetic devices such as artificial teeth, in order to restore the patient's chewing function. The GMI Frontier Dental Implants System is intended for delayed loading.

GMI Frontier consists of dental implant, attachments (straight and angled abutments, healing abutments, ball abutments, temporary cylinders, straight and angled multi-esthetic abutments and their accessories), and clinical screws.

I'm sorry, but this document (K161593 510(k) Premarket Notification for the GMI Frontier Dental Implant System) relates to a dental implant system and does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, I cannot provide the specific details you requested regarding the acceptance criteria and study proving a digital health or AI/ML device meets those criteria. The provided text details the substantial equivalence of a physical medical device (dental implants) to existing predicate devices based on non-clinical performance data (biocompatibility, mechanical properties, sterilization, etc.).

No mention of AI, machine learning, deep learning, algorithms for image analysis, or any form of digital diagnostic assistance is present in this document.

To provide the requested information, I would need a document related to an AI/ML medical device.

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