(87 days)
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
Acceptance Criteria and Study for ROSA Surgical Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mean accuracy for in vitro application | Below 2 mm (for both fiducial markers and optical registration) |
The acceptance criterion for the ROSA Surgical Device was that its in vitro application accuracy should be below 2 mm, which is stated to be equivalent to other commonly used surgical localization systems. The device met this criterion for both fiducial markers and optical registration methods.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 45 measurements were collected for fiducial markers and another 45 measurements for optical registration. This sums to 90 measurements for the test set.
- Data Provenance: The data was collected "in vitro," implying it was generated in a controlled laboratory setting using a phantom skull. There is no information regarding the country of origin of the data provided in the document. The study was prospective in the sense that the tests were specifically designed and executed to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not indicate the involvement of human experts to establish the ground truth for the test set. The ground truth was established by precise measurements using a portable CMM (Coordinate Measuring Machine) with a known accuracy.
4. Adjudication Method for the Test Set
No human adjudication method (e.g., 2+1, 3+1) was used for the test set, as the ground truth was established mechanically through a CMM.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study focused on the standalone performance of the device and not on human readers' improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Device performance tests" were explicitly performed to validate the absolute accuracy and repeatability of the robot arm and the application accuracy for both fiducial markers and optical registration. This involved the algorithm and mechanical system alone, without human-in-the-loop performance being assessed in this specific accuracy study.
7. Type of Ground Truth Used
The ground truth used was based on physical, objective measurements of target points in a phantom skull using a high-accuracy mechanical device. Specifically:
- A phantom skull featuring small metallic balls was used to materialize target points.
- A portable CMM (FARO Titanium arm) with a 50 µm single point accuracy was used to measure the distance between the targeted point and the attained instrument tip position.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. The ROSA Surgical Device is an electromechanical arm and navigation system, and while it's computer-controlled and uses "calculations," the typical concept of a "training set" for machine learning algorithms (as might be present in AI/ML medical devices) is not explicitly detailed or indicated as relevant for its core accuracy validation in this submission. The validation described is for the precision of the mechanical and navigational components.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly described or detailed in terms of its ground truth establishment, this information is not available in the provided text. The accuracy study focuses on the device's performance against a known physical ground truth, rather than validating an AI model's training.
§ 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).