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The C015 device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device.

The device is to be used in healthcare facilities both inside and outside the operating room, in sterile as well as nonsterile environments, in a variety of procedures.

• Applications:
• Orthopedic
• Neuro
• Abdominal
• Vascular
• Thoracic
• Cardiac

The device is intended to be used and operated by adequately tramed, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

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The provided text is an FDA 510(k) clearance letter for the Micronica SRL C015 device. It indicates that the device is an image-intensified fluoroscopic x-ray system.

This type of FDA letter does not include the detailed performance study results, acceptance criteria, or specific information about AI model validation as typically found in submissions for AI/ML-driven medical devices. The C015, being an "image-intensified fluoroscopic x-ray system," is a piece of hardware designed for imaging, not an AI/ML algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML product. The questions posed in the prompt (e.g., number of experts for ground truth, MRMC study, training set size) are relevant to AI/ML device evaluations, which are not described in this regulatory filing.

To provide a comprehensive answer to your request, one would need the specific performance study documentation for the device, which is not part of this 510(k) summary.

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