(224 days)
The Cirq Robotic Alignment Module is an intraoperative robotic positioning system and an accessory to compatible Brainlab IGS Cranial software applications. Using spatial information from an image guided navigation system, the Cirq Robotic Alignment Module enables the surgeon to align and hold surgical instruments according to pre-planned trajectories.
The Cirq Robotic Alignment Module is indicated for stereotactic biopsies of intracranial lesions.
The subject device is intended to serve as a positing and holding device for Brainlab instruments such as drill kits, during surgical procedures.
The device consists of:
- Medical Electrical Equipment Hardware
- I Medical Software
- . Reprocessable Surgical Instruments, and
- Disposable Instruments
The CIRQ Robotic Alignment Module is an adapter containing a motor unit, which is attached to a user-controlled mechatronic holding arm named CIRQ Arm System. The arm is attached to the side rail of an operating table. Together they form a structure capable of holding and positioning instruments.
By using position information acquired by a compatible IGS platform via infrared tracking method, an instrument can be manually pre-aligned roughly to the region of interest by opening the brakes of the CIRQ Arm System. Following this, the tracking information is used to automatically (via the Kinematic Unit attached to the motor unit) fine align the instrument to achieve a pre-planned trajectory controlled by the CIRQ Robotic Alignment Software. After finishing the alignment, the arm with the instrument attached remains in this position and the surgeon can perform the surgical steps intended without losing the trajectory.
The position of the instruments relatively to the patient is visualized via the Cirq Robotic Alignment Software, which is running in a compatible IGS platform (see Figure 2). This software also controls and monitors the movement of the Cirq Robotic Alignment Module.
There are no variants of the device. There is only one configuration for the cranial use case.
The provided text describes the regulatory clearance for the "Cirq Robotic Alignment Module" for stereotactic biopsies of intracranial lesions. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily focusing on bench performance testing.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Positional accuracy with a mean error ≤ 2.0 mm (in worst-case configuration) | Demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm (System accuracy test outcome) |
| Trajectory angle accuracy with a mean error ≤ 2.0 degrees (in worst-case configuration) | Demonstrated performance in trajectory angle accuracy with a mean error ≤ 2.0 degrees (System accuracy test outcome) |
| Stability of Instrument Holder Interface to ensure safe and effective connection | Tested to ensure safe and effective connection between the Cirq Robotic Alignment Module and the Instrument Set. (Specific performance metric for "stability" is not quantified, but the test affirmed it meets the requirement). |
| Locking mechanisms of Tracking Arrays performance over complete expected service life | Tested for their performance over the complete expected service life of 5 years. (Specific performance metric is not quantified, but the test affirmed it meets the requirement). |
| Bone Anchor ensures sufficient fixation to the skull and withstands foreseeable forces | Verified that the Bone Anchor ensures a sufficient fixation to the skull to enable a safe connection to the patient's anatomy during a biopsy procedure and withstands foreseeable forces. (Specific force/fixation metrics are not quantified, but the test affirmed it meets the requirement). |
| Cutting efficiency of the Drill Bit | Verified in a comparing bench test. (Specific efficiency metrics are not quantified, but the test affirmed it meets the requirement). |
| Axial holding force of the Depth Stop ensures safe performance during drilling process | Verified to ensure a safe performance during the drilling process. (Specific force metrics are not quantified, but the test affirmed it meets the requirement). |
| Biocompatibility | Meets the requirements of ISO 10993-1 and ISO 14971 for a device with limited contact duration (≤ 24 hours). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Performance Testing - Bench" which included "simulation tools" and "physical test setups (Instrument and System Accuracy Test)". It does not specify a distinct "test set" in terms of patient data. The accuracy tests were performed "under representative worst-case configuration."
- Sample Size for Test Set: Not explicitly stated regarding the number of test runs or specific items tested for each bench test.
- Data Provenance: Bench testing data, conducted in a laboratory setting by the manufacturer, Brainlab AG, which is located in Munich, Germany. The data is prospective as it describes tests performed on the device to prove its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
Not applicable in this context. The "ground truth" for the bench tests was established through engineering specifications, tolerance analyses, and physical measurement against known standards (e.g., measuring deviation from a planned trajectory/position). There were no human experts establishing ground truth for the device's accuracy in a diagnostic or clinical setting.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against established engineering tolerances and specifications, not subjective human assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not mentioned in the provided document. The device is a robotic positioning system, not an AI diagnostic tool that assists human readers in interpreting medical images. Therefore, improvement in human reader performance with or without AI assistance is not a relevant metric for this device and not discussed.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
The document describes "Performance Testing - Bench" which evaluated the device's accuracy and functionality independently. In this sense, the positional and trajectory accuracy assessments are a form of standalone performance evaluation of the robotic system itself, separate from its operation during a live surgical procedure with a human surgeon. The device enables the surgeon to align and hold instruments, suggesting a human-in-the-loop for the overall surgical procedure, but the bench tests assess the machine's inherent accuracy and mechanical performance in a standalone manner.
7. Type of Ground Truth Used:
For the bench performance tests, the ground truth was engineering specifications and physical measurements against known standards. For example, the "mean error ≤ 2.0 mm" and "mean error ≤ 2.0 degrees" are measured deviations from predefined, ideal positions and trajectories.
8. Sample Size for the Training Set:
Not applicable. The provided document concerns a robotic surgical guidance system, not a machine learning or AI algorithm that requires a training set of data. The device's functionality is based on established robotics and image-guided navigation principles.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no mention of a training set or machine learning components for this device in the provided text.
§ 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).