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The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.

The purpose of this submission is to add a new driver and an accompanying software module to the IPC® . The new system is the IPC® POWEREASE™System. The IPC® POWEREASE™ System provides a powered driver that performs multiple functions and also has nerve stimulation capabilities. The IPC® POWEREASE™ System consists of the Integrated Powered Console (K081475, 10/17/2008), a driver handpiece, and cables to connect the driver, IPC® and NIM-ECLIPSE® System together. The driver is powered by the previously cleared Integrated Powered Console equipped with the appropriate software to operate the driver. The driver is used for drilling, tapping and driving screws in the pedicle, placing screws, and driving working end attachments capable of breaking set screw heads, cutting posts, and cutting rods during spinal surgery. The POWEREASE™ Driver also has nerve stimulation capabilities when connected to the Medtronic NIM -ECLIPSE® System (K061113 - 05/23/2006; K061639 -11/01/2006). An external POWEREASE™NIM Cable that connects the NIM-ECLIPSE® System to the driver enables the driver to have nerve stimulating capability. It should be noted that the IPC® does not provide the stimulation. The stimulation used with the IPC® POWEREASE™ is provided by the Medtronic NIM-ECLIPSE® System.

The driver is equipped with a quick connect feature which allows for easy and secure attachment of different working end attachments compatible with the IPC® POWEREASE™ Driver to perform the various functions mentioned above.

The provided document describes the Medtronic IPC® POWEREASE™ System, a medical device for surgical procedures, and its substantial equivalence to predicate devices. It does not contain information typically found in studies evaluating acceptance criteria and device performance for AI/ML-based medical devices.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Description: The IPC® POWEREASE™ System, a powered driver with nerve stimulation capabilities for spinal surgery.
• Indications for Use: Detailed uses in various surgical procedures, including drilling, tapping, driving screws, and cutting screws/posts/rods in spinal surgery.
• Predicate Device Identification: A list of previously cleared devices to which the IPC® POWEREASE™ System is deemed substantially equivalent.
• Comparison to Predicate Devices: A table comparing features like indications, handpiece compatibility, and nerve monitoring capability.
• Testing: Stating that "Laboratory bench testing conducted on the POWEREASE™ System demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market. Testing was performed according to IEC 60601 Medical Electrical Equipment."
• Conclusion: The device is substantially equivalent based on bench tests, intended use, and design control activities.

This document describes a traditional medical device clearance, not an AI/ML diagnostic or prognostic device that would typically involve the types of performance metrics and ground truth establishment you are asking about.

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