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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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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. These adaptors are specifically designed for use with the Medtronic StealthStation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vital Power Instrument System), 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.

Due to the nature of the provided document, which is a 510(k) summary for a medical device and not a study detailing specific acceptance criteria and performance data in the typical sense of AI/ML device testing, many of the requested fields cannot be directly extracted or are not applicable.

The document describes the Zimmer Biomet Universal Navigation System, a stereotaxic instrument for spinal surgery. The performance data provided focuses on accuracy testing of the instruments in accordance with a particular ASTM standard, rather than clinical performance metrics often associated with AI/ML systems (e.g., sensitivity, specificity, AUC).

Here's a breakdown based on the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in the format of a table with numerical targets and reported values. Instead, it refers to validation activities and accuracy testing. The primary performance claim is related to accuracy as measured by a standard practice.

Implied Acceptance Criterion: The device should meet the performance requirements for accuracy as defined by ASTM F24554-18.

Here's a table based on the summary of performance data presented in the document:

Missing Information: Crucially, the specific numerical results of the accuracy testing are not included in this 510(k) summary. The document states that "validation activities ... confirm the instruments meet performance requirements," implying that the acceptance criteria were met, but the criteria themselves (e.g., "accuracy must be within X mm") and the measured performance (e.g., "accuracy achieved Y mm") are not detailed here.

Additional Requested Information (Based on Document Content)

• Sample sized used for the test set and the data provenance: Not explicitly stated. The testing mentioned in the document is "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments" in accordance with an ASTM standard. This likely refers to in-vitro/bench testing, not a clinical test set with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" are not applicable here.

• 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. This device is not an AI/ML diagnostic or predictive tool that relies on expert interpretation to establish ground truth in a test set. The validation is for the accuracy of navigation instruments, which is typically measured against physical standards or known positions.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons mentioned above.

• 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: Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or an MRMC study. It's a navigation system designed to aid surgeons in precisely locating anatomical structures.

• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "accuracy testing" mentioned is likely a standalone performance assessment of the navigation system's instruments, independent of a human surgeon's interaction during a live procedure, but it's not an "AI algorithm" in the typical sense. It is testing the instrument's ability to accurately track or guide.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For positional accuracy testing of a navigation system, the ground truth would typically be established by highly precise measurement devices or known physical reference points in a controlled laboratory setting, not expert consensus or pathology.

• The sample size for the training set: Not applicable. This device is not described as an AI/ML device that undergoes a "training" phase.

• How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Conclusion based on provided text:

The provided document is a 510(k) summary for a navigation system, not an AI/ML diagnostic or predictive device. As such, many of the questions related to AI/ML device testing methodologies (like training sets, expert adjudication of ground truth, MRMC studies) are not applicable to the information presented. The key performance aspect is the accuracy of the navigation instruments, which was validated according to a recognized ASTM standard, though specific numerical results of this validation are not included in the summary. The FDA deemed this sufficient for substantial equivalence.

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