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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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