(203 days)
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle.
The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.
The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accurately position drill guides, screw drivers, needles, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to accurately position an end-effector over the desired surgical area, and two approximately orthogonal images are captured with a standard flouroscope. The two images are displayed on computer monitors and used to perform accurate intra-operative planning. The plan consists of specifying the instrument entry point, and sagittal and transverse orientations. The system will then calculate the necessary coordinates for the robot ann, which will position the drill guide over the surgical area.
The Fluorotactic Guidance System Mk. I system will consist of four components:
- Robot arm
- Registration/drill guide artifact
- Fluoroscopic image intensifier system (C-arm)
- Personal computer (PC) with a Data Translation image acquisition card and two monitors
The robot arm will hold a registration artifact which is transparent to X-rays over the patient in proximity to the desired surgical area. This artifact has eight steel balls embedded such that when the C-arm is used to capture images of the area, the balls will create fiducial shadows on the image. Two images will be required, an Anterior/Posterior (A/P) view and a Sagittal view.
The PC will receive the image data from the C-Arm and display it on two monitors. The surgeon will indicate the desired positioning of the drill by manipulating a virtual guidewire on the screens. The software will then use the fiducial location information to calculate the coordinates for the positioning of the drill guide, and the robot arm will move to the new orientation.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Z-KAT Fluorotactic Guidance System Mk. I, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting the results of a specific performance study against pre-defined acceptance criteria.
However, based on the description of the device and its intended use, we can infer the types of performance criteria that would be relevant for such a system. The core function is the "accurate placement" of surgical instruments using "coordinated-fluoroscopy" and a "robot arm" to achieve a "precise position." Therefore accuracy would be the primary metric.
Here's a hypothetical structure of the requested information, acknowledging that the specific values and study details are not present in the provided text and would need to be synthesized or assumed for a complete answer.
Inferred Acceptance Criteria and Hypothetical Performance Study (Based on device description)
Given that the Z-KAT Fluorotactic Guidance System Mk. I is designed to assist in the "accurate placement of a guiding device for surgery," the primary acceptance criterion would relate to the accuracy of instrument positioning.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Value (Hypothetical) | Reported Device Performance (Hypothetical) | Meets Criteria? (Hypothetical) |
|---|---|---|---|
| Linear Trajectory Placement Accuracy | ≤ 1.0 mm | Mean error: 0.75 mm (95% CI: 0.60-0.90 mm) | Yes |
| Angular Trajectory Placement Accuracy | ≤ 1.0 degree | Mean error: 0.8 degrees (95% CI: 0.65-0.95 degrees) | Yes |
| System Set-up Time | ≤ 10 minutes | Mean time: 8 minutes | Yes |
| Image Acquisition Latency |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).