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The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures.

Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

The Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. Same as the predicate device the modified Mazor X consists of a workstation with dedicated software, the surgical system, navigation camera, accessories, instruments and disposable kits. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the Mazor X System cleared in 510(k) K203005.

The provided text is a 510(k) Summary for the Mazor X System (Mazor X Stealth Edition), detailing its substantial equivalence to a predicate device (K203005). The document focuses on comparing technological characteristics and asserting that modifications do not raise new safety or effectiveness concerns.

However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested by the prompt. This document is a regulatory submission demonstrating substantial equivalence, not a clinical study report with performance metrics like accuracy, sensitivity, or specificity against defined ground truth.

Therefore, many parts of your request for acceptance criteria and study details cannot be fulfilled from the provided text.

Here's what can be extracted and what is missing:

Device: Mazor X System (Mazor X Stealth Edition)

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance in terms of equivalence to a predicate device rather than specific acceptance criteria for a new study. The closest to "acceptance criteria" related to performance are the accuracy metrics established by the predicate device.

Note: The document explicitly states: "A series of performance bench testing demonstrated that the absolute robotic depth error is smaller than ±1.5 mm and that the overall system accuracy is equivalent to the predicate device system accuracy. In addition, the navigation accuracy was tested and found to be equivalent to the navigation accuracy performance of the predicate device (mean positional error <2mm and mean trajectory error of 2°)."

2. Sample Size and Data Provenance

• The document mentions "Bench testing" and "Non-Clinical Performance Data" but does not specify the sample size used for these tests (e.g., number of cadavers, phantoms, or clinical cases, if any).
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The testing described appears to be laboratory/bench testing, not clinical data from patients.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not stated. The ground truth for device accuracy (positional, trajectory, depth) would typically be established by highly precise measurement systems (e.g., optical tracking, CMM) during bench testing, not by human experts interpreting images for diagnostic purposes. The document doesn't describe any human expert review process for determining the accuracy metrics.

4. Adjudication Method for the Test Set

• Not applicable. As the ground truth is established via precise measurements in a bench test setting for accuracy, an adjudication method for human interpretation is not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No evidence of MRMC study. The document describes a robotic and navigation system's accuracy, not a diagnostic or assistive AI system that requires human reader improvement analysis.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly. The performance data (robotic and navigation accuracy) are presented as inherent capabilities of the device itself, derived from "bench testing." This would be the "standalone" performance of the robotic system's guidance capabilities.

7. Type of Ground Truth Used

• Based on the description of "bench testing" for "robotic depth mean accuracy," "system accuracy," and "navigation accuracy," the ground truth likely involves physical measurements using highly accurate instruments (e.g., CMM, optical trackers, etc.) on phantoms or test setups, calibrated against known standards. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Not applicable / Not stated. This document describes a robotic surgical system, not a machine learning or AI model in the sense of one that learns from a "training set" of patient data (e.g., images for diagnosis). The software modifications mentioned are "enhancements to enable extended functionality" and "UX/UI improvements," rather than the introduction of a new AI algorithm requiring a large training dataset with labelled ground truth. The system relies on its inherent mechatronic precision, optical tracking, and image processing capabilities rather than patterns learned from a data training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. See #8. No training set is described for an AI/ML model that would require such ground truth establishment.

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