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The intended use is for drilling, reaming, and decorticating of bone and other bone-related tissue during general surgical orthopedic procedures in a variety of surgical procedures. It is also usable in the placement of screws, wires, pins, and other fixation devices.

This attachment is designed for general surgical use where hard tissue and/or bone must be cut, reamed, drilled, and/or fixated with screws, including but not limited to, the hand, wrist, elbow, sternum, shoulder, foot, ankle, knee, and hip.

The intended use is also to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws, in non-cervical spine surgical procedures.

The Stryker POWEReam ¼" Drive is an attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function. The design reduces the speed and increases the torque output from the handpiece by a ratio of 5:1. The accessories are intended for drilling, reaming, and decorticating of bone and other bonerelated tissue during general orthopedic procedures in a variety of surgical procedures.

The purpose of this premarket notification is to seek clearance for a new indication for the Stryker POWEReam 1/4" Drive (part number 4405-250-000). This indication is for facilitating the placement of pedicle screws in non-cervical spine surgical procedures.

The provided document is a 510(k) premarket notification for a medical device called "POWEReam 1/4" Drive" manufactured by Stryker Instruments. It is a traditional 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device.

The crucial point for your request is that this device is a mechanical surgical instrument, not an AI/software-based medical device. Therefore, the concepts of acceptance criteria for AI performance, training sets, test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The document explicitly states:

• "Summary of Non-Clinical Testing: A suite of non-clinical testing was executed to demonstrate substantial equivalence to the predicate device. Testing included: Performance Design Verification Testing, Human Factors and Usability Engineering, Simulated Use Design Validation Testing. All pre-defined acceptance criteria for the above tests have been met." (Section 7.7)
• "Summary of Clinical Testing: Clinical testing was not required for this traditional 510(k)." (Section 7.8)

This means the acceptance criteria and performance data are related to the mechanical and functional aspects of the device (e.g., torque, speed reduction, human factors of use), not diagnostic accuracy or AI performance on medical images.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI-based device, as this document describes a traditional mechanical surgical instrument submission.

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