(193 days)
"POINT" Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
The device is indicated for medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
"POINT" Kinguide Robotic-Assisted Surgical System (Kinguide Surgical System) is an orthopedic stereotaxic medical device, which consists of a hand-held robot, a passive arm, a workstation, an infrared navigation camera, navigation software, C-arm ring calibrator and surgical navigation accessories. Among them, the workstation, as the main console for controlling the hand-held robot, is equipped with a computer and control modules, which performs all operations in the surgical procedure through the computer, and transmits its information to the control modules for controlling movements of the hand-held robot. The C-arm ring calibrator and the navigation probe are used to perform registration process. The infrared navigation camera receives the spatial positioning of the patients, the hand-held robot and the surgical accessories through Dynamic Reference Frames (DRFs), and in the meantime the camera sends the data back to the workstation for monitoring stereotactic surgical operation.
The Kinguide Surgical System can assist surgeons to find surgical trajectories quickly and precisely during surgical operations. Software application in the system provides the patient's image to match coordinates of the patient's anatomical structure, and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map with navigable tools.
Here's a breakdown of the acceptance criteria and study information for the "POINT" Kinguide Robotic-Assisted Surgical System based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Accuracy: Mean Location Error | ≤ 2.0 mm (met criteria) |
| Positional Accuracy: Mean Trajectory Angle Error | ≤ 2° (met criteria) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "cadaveric validation" was performed. However, it does not specify the sample size for the test set (i.e., the number of cadavers or specific test cases used). The data provenance is cadaveric. The document does not specify the country of origin or if the study was retrospective or prospective, although cadaveric studies are inherently prospective for device testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The device described is a robotic-assisted surgical system, not an AI for image interpretation or diagnosis that would directly involve human readers in that capacity.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
The performance described (positional accuracy for location and trajectory) appears to be a standalone performance of the robotic system itself in achieving targets. The study evaluates the system's ability to guide to a precise location and trajectory, implying an algorithm-only (robotic system only) performance in meeting these physical accuracy metrics. The role of a human surgeon would be to operate the system, but the accuracy itself is attributed to the robotic assistance.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance (accuracy) was established through verification and validation activities, including a "Cadaveric Validation Report," as stated. This suggests that precise physical measurements on cadaveric specimens were used to define the true position and trajectory, against which the robotic system's performance was compared.
8. Sample Size for the Training Set
The document does not provide information about a specific "training set" or its sample size. This type of robotic system involves engineering design and calibration rather than a machine learning model that would typically have a distinct training set for data-driven learning.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a training set in the context of machine learning, the document does not describe how ground truth for a training set was established. The device's accuracy is likely established through engineering specifications, calibration procedures, and validation against known physical standards.
§ 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).