(118 days)
The Renaissance System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in open or minimally invasive or percutaneous procedures.
Renaissance 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
The Renaissance System is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide accuracy, precision and accessibility in performing general spinal and brain procedures. The Renaissance System is designed to assist surgeons in precisely guiding handheld surgical tools and/or implants (in spinal surgery) according to a computerized, image-based, pre-operative plan along a given traiectory. The Renaissance System Brain Application was developed based on the same principles of operation for image guided brain surgeries. The Renaissance System Brain Application processes MRI and CT images via proprietary algorithms and based on the preoperative plan the RBT Device is programmed to position its articulating arm and thus the surgical instrument at the desired coordinates. Using a special skull attachment component (i.e., the RBT Base), the RBT Device attaches to the skull in the area where the procedure is being performed, and assists surgeons in precisely positioning the handheld surgical tools according to the computerized, image-based, pre-operative plan.
The main components of the Renaissance System Brain Application include:
- A. The RBT Device
- B. Workstation Console in the OR and Planning PC Workstation in the physician's office
- C. Renaissance Brain Application Accessories including RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.
Here's a summary of the acceptance criteria and study information for the Renaissance System with Brain Application, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predefined Device Specifications) | Reported Device Performance (as stated in the document) |
|---|---|
| Accuracy of registration process met predefined device specifications. | The accuracy assessment was performed on a human head phantom. The accuracy of the registration process met the predefined device specifications. |
| Overall mean accuracy of less than 1.5mm in both target plane and target depth (Bench Accuracy Study) | The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1.5mm in both target plane and target depth. |
| Overall mean accuracy of less than 1.5mm in both target plane and target depth, and repeatable performance (Cadaver Accuracy Study) | The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1.5mm in both target plane and target depth, as well as repeatable performance. |
| Stability of the anchoring system to the skull, with minimal shift and pull-resistance. | The results demonstrated that the anchoring of the Renaissance System Brain Application is stable and pull-resistance. |
| Software validation according to IEC 60601-1-4 and FDA Guidelines for Pre-Market Submissions for Software | Validation of the device software was performed according to the IEC 60601-1-4 standard and the FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices. Each software validation document was written according to the relevant IEEE standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for a "test set" in the traditional clinical trial sense. The performance evaluations were conducted using:
- Human head phantom: Used for the Registration Accuracy Test.
- Cadaver brain: Used for the Cadaver Accuracy Study.
The data provenance is not explicitly stated in terms of country of origin of the data. Both studies (phantom and cadaver) would be considered pre-clinical performance evaluations rather than retrospective or prospective clinical studies involving human patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the accuracy studies (phantom and cadaver) would have been established by physical measurements and the known "targets" within these models.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of human-reviewed ground truth or a need for adjudication in these performance studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the performance of the device itself (standalone accuracy and stability) rather than its impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was done
Yes, standalone performance studies were done. The "Bench Accuracy Study" and "Cadaver Accuracy Study" directly assess the algorithmic and mechanical accuracy of the Renaissance System Brain Application without a human-in-the-loop interacting with the system's output for diagnostic or decision-making purposes. These studies measured the device's ability to precisely guide instruments to a target.
7. The Type of Ground Truth Used
The ground truth used for the performance studies was based on:
- Known physical measurements/targets: For the Bench Accuracy Study, the ground truth would be the pre-defined target coordinates and depth in the testing setup.
- Known anatomical locations/targets: For the Cadaver Accuracy Study, the ground truth would be specific, identifiable anatomical points or simulated targets within the cadaver brain.
- Imaging truth: For the Registration Accuracy Test, the ground truth would be the known spatial relationship between features in the different imaging modalities (MRI, CT) against which the fusion/registration accuracy is measured.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This submission is for a medical device that assists in surgery through image guidance and robotics, not a machine learning model that requires a separate training set in the typical sense. The "proprietary algorithms" mentioned would likely have been developed and refined using engineering principles and simulated (or possibly internal, unmentioned) data, but the specific "training set" size is not relevant or disclosed in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable, as a conventional "training set" with established ground truth in the context of machine learning is not discussed or relevant to the information provided for this device submission. The underlying principles for the algorithms would have been established through engineering design, physics, and mathematical modeling, rather than through a labeled training dataset.
§ 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).