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For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.

OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior and anterior slope positioning, etc.) after insertion into the space between the tibia and the femur.

The provided text is a 510(k) summary for the OrthoSensor VERASENSE™ Knee System, which describes a modification to an existing device. It focuses on regulatory approval for labeling changes and physical modifications to allow compatibility with another knee system.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its performance or effectiveness in the way an AI/ML device would be evaluated (e.g., accuracy, sensitivity, specificity).

The document states:

"The modifications to the Orthosensor VERASENSE™ Knee System were evaluated under design controls, and met the same performance criteria as the predicate device."

This indicates that the modified device was tested against the same performance criteria as the original predicate device, not that a new study was conducted to establish new acceptance criteria or to prove clinical effectiveness of the device's intended use (reducing instability from flexion gap asymmetry). The changes are primarily related to mechanical compatibility and labeling.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert involvement, or MRMC studies for this specific submission, because that information is not present in the provided text.

The document discusses:

• Intended Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry.
• Device Description: An instrumented trial tibial insert with load sensors and angular positional information.
• Changes: Modification to package label to reflect use with Biomet Vanguard Knee System, changes to device surface contours and dimensions specific to the Biomet Vanguard Knee System, and addition of a new color of Polycarbonate.
• Design Control Activities: The modifications were evaluated under design controls and "met the same performance criteria as the predicate device."
• Substantial Equivalence: The submission claims substantial equivalence to the predicate device, stating it has the same intended use and technological characteristics that do not raise different questions of safety and effectiveness.

In summary, the provided text does not contain the specific information required to answer the prompt regarding acceptance criteria and performance study details for an AI/ML device.

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