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510(k) Data Aggregation
(231 days)
The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative guidance and tool trajectory / position confirmation.
The VUZE System (the "System") enables users to load 3D images and planning data then register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device quidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation. fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7.
The System offers optional pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative guidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intra-operative 2D images onto a patient's pre-operative 3D images.
The System's main components include:
- A workstation running the VUZE Planning and Procedure software (pre-installed)
- A housing for the workstation, with a front door for user access as well as a back service door
- A 32" touchscreen
- A mouse
- An isolation transformer
- An internal video acquisition device (frame grabber)
- A minimal-footprint, wheeled cart on which the above-listed items are placed.
- DVI cable with galvanic isolator
- An optional standalone planning station (planning software running on a commercial PC with identified specifications)
- Optional C-arm orientation sensors (3), charger, and associated Bluetooth dongle (Note: The orientation sensor may also be referred to under an acronym of IMU)
- Optional OTS foot pedal and associated Bluetooth dongle
Acceptance Criteria and Study for the VUZE System (K232976)
Based on the provided FDA 510(k) summary, the VUZE System is a medical imaging system for spinal interventions. The submission focuses on evaluating the substantial equivalence of a modified VUZE System to its predicate device (original VUZE System K210830). The performance data presented primarily assesses the quantitative accuracy of the system's core function: registering pre-operative 3D images with intra-operative 2D radiographic images to guide surgical tools.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established as Root Mean Square (RMS) specification limits and quantile limits for various accuracy parameters. The reported device performance is based on testing at "Recommend Angles" and "Minimal Angle Difference" scenarios.
| Parameter | Acceptance Criteria | Reported Device Performance (Recommend Angles) | Status | Reported Device Performance (Minimal Angle Difference) | Status |
|---|---|---|---|---|---|
| RMS Specification Limits | |||||
| Direction error [deg] | ≤ 3° | 0.3094° | Pass | 0.4537° | Pass |
| Tip deviation from GT trajectory [mm] | ≤ 2 mm | 0.2833 mm | Pass | 0.4107 mm | Pass |
| Predicted tip deviation from GT trajectory [mm] | ≤ 2 mm | 0.3572 mm | Pass | 0.5199 mm | Pass |
| Depth error [mm] | ≤ 4 mm | 0.8196 mm | Pass | 1.0194 mm | Pass |
| Quantile Specification Limits (95% / 2.5% & 97.5%) | |||||
| Direction error [deg] | -6.5 mm (2.5th percentile) | -1.371 mm (2.5th percentile estimate) | Pass | -1.939 mm (2.5th percentile estimate) | Pass |
| Depth error [mm] Upper |
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