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The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems prostheses families only.

The Materialise PKA Guides are intended for single use only.

Materialise PKA Guides are patient-specific medical devices that are designed to implant partial knee prosthesis.

The Materialise PKA Guides must only be used in conjunction with the 510(k) cleared, legally marketed prosthesis. Consult the prosthesis labeling and instructions for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Materialise PKA Guides is an instrument set containing a femur and/or tibia template(s) and bone models.

The provided document is an FDA 510(k) Premarket Notification for the Materialise PKA Guide System. While it discusses the device's intended use, technological characteristics, and comparison to predicate devices, it does not contain detailed information about specific acceptance criteria or the study that directly proves the device meets those criteria for software performance.

The document states: "Testing verified that the accuracy and performance of the system is adequate to perform as intended. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are the same as that of the predicate Zimmer Patient Specific Instruments System (K112301) and therefore previous cadaver testing on predicate device K112301 is considered applicable to the subject device."

This indicates that general performance and accuracy testing was conducted, and the results were deemed adequate. However, it does not provide the specific "acceptance criteria" or the "reported device performance" in a quantitative table format, nor does it detail the specifics of such a study (sample size, data provenance, ground truth establishment, etc.).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the detailed study information based on the provided text. The document refers to "previous cadaver testing on predicate device K112301" as applicable, but it does not describe this testing in detail.

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