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The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized

The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.

It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.

It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach.

The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.

Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.

It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.

The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.

The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance.

The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.

The robotic quidance feature utilizes the same principle of optical position determination technology. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.

The provided text describes a 510(k) premarket notification for the SURGIVISIO Device, focusing on a design modification to the Spine CoBot instruments used with its robotic guidance feature. The core of the submission addresses the device's substantial equivalence to previously cleared versions and predicates.

Here's a breakdown of the acceptance criteria and study information, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the accuracy and angular error criteria are "Identical" to the predicate, implying these thresholds are the acceptance criteria. The specific numerical results from the cadaveric study are not explicitly provided in the summary, but the conclusion of "substantial equivalence" implies these criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

The text mentions a "cadaveric study" was performed.

• Sample Size: Not explicitly stated.
• Data Provenance: Cadaveric, implying human anatomical specimens. No country of origin is specified. The study type is effectively prospective in the sense that the new device modification was tested on these cadavers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The cadaveric study assessed accuracy and safety, but it's not clear how "ground truth" for accuracy was established (e.g., gold standard measurements, comparison to expert placement) or how many experts, if any, were involved in these assessments or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Was it done?: No, an MRMC study was not conducted. The performance data section explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." The tests performed were nonclinical (sterilization validation, cadaveric study).
• Effect size of human readers improve with AI vs without AI assistance?: Not applicable, as no MRMC or clinical study involving human readers and AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a "stereotaxic instrument" with "robotic guidance," intrinsically designed for human-in-the-loop use. The cadaveric study assessed the "accuracy of the robotic guidance feature" and "safety of the robotic guidance feature." While the robotic guidance itself has an algorithm, the performance assessment implies its use in the context of guiding surgical instruments. Therefore, a purely "standalone" algorithm-only performance study, disconnected from its intended use with instruments and human oversight, is not explicitly described or indicated as the primary method of evaluation. The "device accuracy" and "angular error" metrics would represent the precision of the robotic system itself, which is a form of standalone performance for the mechanical guidance aspect.

7. Type of Ground Truth Used

For the accuracy assessment in the cadaveric study, the "ground truth" would likely be:

• Instrumented measurements: High-precision measurement devices (e.g., optical trackers, CMM arms) used to determine the actual position and angle of the guided instruments or planned trajectories on the cadaver, against which the device's reported accuracy is compared. This is implied by the quantitative accuracy and angular error metrics.

8. Sample Size for the Training Set

This document describes a premarket notification for a modification to an already cleared device. It does not provide information about the training set used for the original development of the SURGIVISIO device's software or algorithms. The current submission focuses on demonstrating that design modifications to instruments do not negatively impact the device's accuracy and safety, rather than developing new algorithms that would require a new training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, as it pertains to the original development of the device's algorithms, which is outside the scope of this specific 510(k) submission for a design modification.

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