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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-overative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates.

The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in pre-operative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

Modifications have been made to some of the applications to improve the overall workflow: however, the patient specific guides and bone models remain unchanged from the predicate. In addition, modifications have been made to the user interface of the planning application.

The provided text is a 510(k) summary for the Signature™ ONE System, a device for pre-operative planning and intra-operative guiding for shoulder replacement surgery. It discusses the device's indications for use, its similarity to a predicate device, and modifications made. However, the document does not contain the specific information requested regarding acceptance criteria, detailed study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), or the ground truth establishment process.

The section "Summary of Performance Data (Nonclinical and/or Clinical)" only states:

• "Addition of a landmark to the Signature ONE Planner to display the location of the deepest glenoid point"
• "A feature is added to the Signature ONE Planner to display the medial/lateral translation between the backside on the implant and a reference landmark located on the most lateral point of the glenoid"
• "A feature is added to the Signature ONE Planner to display the percentage of contact between the selected implant and the glenoid surface"
• "All of the test steps passed successfully."

This is a very high-level summary and does not provide the detailed study information needed to answer your questions. This type of FDA clearance (510(k)) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, complex clinical trial data as might be seen for novel technologies or PMA (premarket approval) applications.

Therefore, I cannot provide the requested information from the given text. The document indicates that tests were performed and passed, but the specifics of those tests, the acceptance criteria, and how they proved the device meets those criteria are not detailed in this summary.

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