(88 days)
Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy.
As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.
The Spine & Trauma Navigation is an image guided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use image data based on CT, MR, 3D fluoroscopic image reconstruction (cone beam CT) or 2D fluoroscopic images coming from the compatible imaging device LoopX. It offers different patient image registration methods and instrument selection and calibration to allow surgical navigation by using optical tracking technology.
The software is installed on a mobile or fixed Image Guided Surgery (IGS) platform to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms comprise of a mobile Monitor Cart or a fixed ceiling mounted display and an infrared camera for image guided surgery purposes.
The Spine &Trauma Navigation consists of the following components:
- . Software enabling instrument selection, different registration methods (e.g. surface matching) as well as navigation in different types of images.
- . IGS platforms
- . Surgical instruments for navigation, patient referencing and registration
The Alignment System Spine is an accessory to the Spine & Trauma Navigation. It serves as a holding and positioning system to support the surgeon in reaching a pre-defined screw with surgical instruments. The device needs to be first manually pre-aligned to the region of interest by opening the brakes of the Cirq Arm System. Then tracking information provided by the optical camera is used by the Alignment Software Spine 2.0 to control the movement of the Cirq Robotic Motor Unit to perform the final automatic fine alignment. Once the alignment to the planned screw is done, the Alignment System Spine maintains its position during the rest of the procedure and Spine & Trauma 3D Navigation takes over the navigation of the instruments. The Alignment System Spine consists of the following components:
- Alignment Software Spine 2.0 ●
- Cirg Arm System with multiple structural hardware components ●
- Cirq Robotic Motor Unit
- Cirq robotic instruments
The provided document, K221618, describes the clearance of "Spine & Trauma Navigation" and "Alignment System Spine" devices. The performance data section focuses on system accuracy testing, which serves as the primary study proving the device meets acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mean Positional Error (instrument's tip) | ≤ 2 mm |
| Mean Angular Error (instrument's axis) | ≤ 2° |
The document states: "The results show the following acceptance criteria are fulfilled:
- Mean Positional Error of the placed instrument's tip ≤ 2 mm
- Mean Angular Error of the placed instrument's axis ≤ 2°"
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of cases or sample size used for the "System accuracy testing." It mentions, "The 2D and 3D positional and angular navigation accuracy of the Spine & Trauma Navigation including the software, the platforms and the instruments was evaluated considering a realistic clinical setup and representative worst-case scenarios."
Data Provenance: The document does not specify the country of origin for the data. The testing appears to be pre-clinical/laboratory-based performance testing rather than a study involving patient data. It is explicitly stated: "No clinical testing was needed for the Subject Device." Therefore, it's not a retrospective or prospective clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This was a system accuracy test, not an evaluation of diagnostic performance requiring expert ground truth establishment for a test set. The ground truth for positional and angular accuracy would be established by the precise measurements of the testing apparatus itself.
4. Adjudication Method for the Test Set
Not applicable. As this was a system accuracy test, there was no human interpretation or subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical testing was needed for the Subject Device." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.
6. Standalone (Algorithm Only) Performance
Yes, in essence. The "System accuracy testing" evaluates the performance of the navigation system (including its software, platforms, and instruments) in a simulated environment, independent of a human surgeon's real-time decision-making abilities. While it’s not an AI algorithm in the sense of image interpretation, it's the performance of the automated/assisted navigation system.
7. Type of Ground Truth Used
The ground truth used for the system accuracy testing would be based on physical measurement standards. This involves precisely measured and known positions and angles of the instruments relative to the anatomical models or phantoms used in the "realistic clinical setup and representative worst-case scenarios." The positional and angular errors are calculated against these known, precise ground truth values.
8. Sample Size for the Training Set
The document does not mention the existence of a machine learning or AI algorithm that would require a "training set" in the traditional sense. The device is described as an "image-guided localization system" and "computer-assisted navigation," suggesting deterministic algorithms rather than trainable machine learning models. Therefore, the concept of a training set and its size as typically understood for AI/ML devices is not applicable or provided in this document.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for an AI/ML algorithm is not described or implied for this device.
§ 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).