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The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The universal adaptors are specifically designed for use with the Zimmer Biomet ROSA One System, which is indicated for providing spatial positioning and orientation of instrument holders or tool guides based upon an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The ROSA One Spine System is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.

The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vitality MIS), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.

The provided text describes the Zimmer Biomet Universal Navigation System and its 510(k) clearance. However, it does not contain specific details about acceptance criteria, a detailed study proving performance against those criteria, or the methodology (sample size, expert qualifications, ground truth, MRMC study, standalone performance) typically associated with a robust clinical or technical validation study for an AI/ML medical device.

The closest information provided is:

• "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments was performed in accordance ASTM F2554-18 Standard Practice For Measurement of Positional Accuracy of Computer Assisted Surgical Systems."
• "Clinical data was not needed for the Zimmer Biomet Universal Navigation System."

This indicates that the validation was focused on the system's positional accuracy and relied on a standardized test method (ASTM F2554-18), rather than a clinical study evaluating diagnostic or treatment outcomes with human readers.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified. The document mentions "accuracy testing" but does not detail the number of trials, cases, or specific measurements performed.
• Data provenance: Not applicable in the context of clinical data, as it states "Clinical data was not needed." For the accuracy testing, the "data" would be the measurements taken during the experimental procedure according to ASTM F2554-18. The origin of this experimental setup is not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The validation was a technical accuracy test, not a clinical study requiring expert interpretation of medical images or outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The document explicitly states, "Clinical data was not needed for the Zimmer Biomet Universal Navigation System." Therefore, an MRMC study and AI assistance comparison were not conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Yes, implicitly. The "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments" performed per ASTM F2554-18 is a standalone technical performance test of the device's ability to measure spatial positioning accurately, independent of human interpretation of clinical outcomes. However, the specific metrics of this standalone performance are not reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the accuracy testing, the ground truth would be based on precisely established physical reference points and measurements in a controlled environment, as defined by the ASTM F2554-18 standard for measuring the positional accuracy of computer-assisted surgical systems. It's a "physical ground truth" related to spatial measurement, not a biological or clinical ground truth.

8. The sample size for the training set

• Not applicable. This device is a navigation system, not an AI/ML algorithm that requires a training set in the conventional sense (e.g., for image classification or risk prediction). Its "training" would be its engineering design and calibration.

9. How the ground truth for the training set was established

• Not applicable, as there isn't a "training set" for an AI/ML algorithm in this context.

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