(227 days)
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indical for any medical condition in which the use of stereotaxtic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:
- · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- Iliosacral Screw Placement
The NextAR Spine platform is intended to be used in combination with NextAR™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:
- Navigation software which displays information to the surgeon; ●
- Augmented Reality glasses; ●
- Optical tracking system; ●
- PC based hardware platform; ●
- Fiducial Block: ●
- Adaptor for sensor:
- Spine attachment instruments ●
- Reusable surgical instruments for spine surgery procedures. ●
The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.
The NextAR™ Spine Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor.
The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D-CArm scan in order to register the spine to navigation elements.
The registration can be performed with one of the following approaches: - Direct 3D: based on the use of an intra-operative 3D-CArm scan ●
- . 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan
The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.
Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating numerical acceptance criteria for clinical performance. However, based on the performance data section, the device's accuracy was a key performance metric evaluated. The acceptance criteria for accuracy are not explicitly stated in numerical terms in this document, but the study described aimed to confirm its performance comparable to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Accuracy | Comparable to predicate navigation systems in spine procedures. | "Accuracy test" was conducted and the "Cadaver study" supports the device's ability to precisely locate anatomical structures and aid in screw placement. While specific numerical accuracy metrics (e.g., error in mm) are not stated in this summary, the conclusion states substantial equivalence has been demonstrated through performance evaluations. |
| Software Validation | Software functions as intended and meets specifications. | Performed. |
| Biocompatibility | Meets ISO 10993-1:2009 standards. | Performed. |
| Sterilization Validation | Device can be effectively sterilized. | Performed. |
| Shelf-life Testing | Device maintains integrity over its shelf life. | Performed. |
| Shipping Test | Device withstands shipping conditions. | Performed. |
| Electrical Safety | Conforms to IEC 60601-1:2005 and amendments. | Performed. |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2:2014. | Performed. |
| Mechanical & Optical Properties | Meets performance expectations. | Performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions a "Cadaver study" as part of the performance testing.
- Sample Size: The exact number of cadavers used is not specified in the provided text.
- Data Provenance: The study was a "Cadaver study," indicating it was conducted on human cadavers. This is a form of retrospective data in terms of patient-specific outcomes, as the cadavers represent once-living individuals, but the experimental setup is controlled like a prospective study. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide details on the number of experts or their specific qualifications (e.g., radiologists with X years of experience) used to establish ground truth within the cadaver study. It states the system is intended to aid surgical placement, implying the ground truth would typically be related to the accuracy of instrument placement or trajectory relative to anatomical landmarks, ideally verified by expert assessment or post-procedure imaging analysis.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1) for the test set (cadaver study).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size regarding human readers improving with AI vs. without AI assistance. The device is a navigation platform for surgeons, implying human-in-the-loop assistance, but a formal MRMC study as typically performed for diagnostic AI is not described.
6. Standalone (Algorithm Only) Performance:
The document does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study. The device is designed as a "surgical navigation platform" to "aid the surgeon" and display information "in real-time on a screen monitor," indicating an inherent human-in-the-loop design.
7. Type of Ground Truth Used:
For the "Accuracy test" and "Cadaver study" related to placement, the ground truth would likely involve:
- Precise measurements of instrument tip position or trajectory relative to anatomical landmarks.
- Verification using high-resolution imaging (e.g., CT scan) of the cadaver after "screw placement" to assess deviation from planned trajectories or ideal anatomical placement.
The document does not explicitly state the method for establishing ground truth, but for a navigation system, it would generally be based on anatomic truth verified by imaging or detailed measurements.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size for a training set. As a substantial equivalence determination, the focus is on performance testing and comparison to predicates, not on the details of algorithmic training. The "Dedicated algorithm" is mentioned as a technological characteristic, implying machine learning components, but its training details are not disclosed here.
9. How the Ground Truth for the Training Set Was Established:
Since there is no information on a training set, the document does not provide details on how its ground truth was established.
§ 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).