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The PSPS bone model is indicated, based on patient-specific radiological images (CT scans), to assist in pre-operative orthopedic planning for patients able to undergo orthopedic procedures and able to be radiologically scanned.

The PSPS bone model is a diagnostic tool to visually aid in orthopedic pre-operative surgical planning for skeletally mature individuals.

Be advised, the quality of medical images determines the accuracy of the 3D bone models. Zimmer Biomet recommends using CT Protocol PMI® Patient-Matched Implants CT Protocol. Only images obtained less than six (6) months prior should be used for simulating and/or evaluating orthopedic treatment options.

The Patient Specific Planning Solution™ 3D Bone Model is a 3-dimensional representation of the requested anatomical bone site. The Bone Models are diagnostic tools to allow the Surgeon to physically and visually aid in pre-operative orthopedic planning to facilitate the implantation of medical devices.

The Patient Specific Planning Solutions™ are designed of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized orthopedic pre-surgical plan and shipped prior to surgery. The Bone Models are provided non-sterile and are used pre-operatively for education, planning to aid in component selection, sizing, and placement based on patient specific radiological images (CT scan). Physical bone models' critical bony areas are printed at

This document does not contain the detailed information necessary to fully answer all aspects of your request, specifically regarding a multi-reader multi-case (MRMC) comparative effectiveness study, the number of experts for human-in-the-loop studies, the adjudication method, or specific effect sizes. The submission focuses on substantial equivalence to a predicate device, Mimics Medical (K183105), rather than a detailed performance study against specific acceptance criteria for a new AI algorithm.

However, based on the provided text, here's what can be extracted and inferred regarding the device's acceptance criteria and proven performance:

Device: Patient Specific Planning Solution™ Bone Models

Device Function Summary: These are 3D printed physical bone models derived from patient-specific CT scans. They are intended as diagnostic tools to visually aid in orthopedic pre-operative surgical planning and to facilitate the implantation of medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily related to the geometric accuracy of the 3D-printed bone models compared to the digital input. The performance summary refers to the device utilizing the same geometric accuracy testing as its predicate.

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