(162 days)
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic 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 posterior approach spinal procedures, such as:
- Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- Sacro-Iliac Screw Placement
NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.
The NextAR Spine platform is intended to be used in combination with NextAR™ Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning, surgical planning software is used pre-operatively 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.
NextAR Spine sterile drill and pins
The sterile drills, pins and iliac pins are part of the NextAR Spine platform which is intended as an aid for precisely locating anatomical structures in either open / mini open or percutaneous spine procedures. The NextAR Spine sterile drills pins and iliac pins are intended for use with the NextAR Spine platform according to its approved indications for use. All the drills are motorized. Pins may be used either motorized or manually. Iliac pins are manual.
The NextAR™ 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
- 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.
NextAR™ Spine aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The platform uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D scan in order to register the spine to navigation elements. The registration can be performed with one of the following approaches: 1) Direct 3D: based on the use of an intra-operative 3D scan, or 2) 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan.
Where the Direct 3D approach is utilized, NextAR™ Spine allows for planning of screw positioning on the patient's intraoperative DICOM images just before system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.
The NextAR™ Spine platform also includes the rod planning tool, which gives the surgeon information about the length and the rod type to best fit the spine anatomy and to perform the desired curvature correction.
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.
The FDA 510(k) clearance letter for NextAR™ Spine (K250477) provides limited details on a comprehensive study proving acceptance criteria. However, based on the provided text, we can infer some aspects of the performance data and the methods used to demonstrate the device's substantial equivalence.
Here's an attempt to structure the information based on your request, highlighting what is explicitly stated and what can be inferred or is missing from this document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list acceptance criteria in a quantitative table format nor does it provide numerical performance metrics. Instead, it relies on comparative evaluations and qualitative assessments to demonstrate substantial equivalence to predicate devices. The "Performance Data" section primarily focuses on non-clinical studies.
| Acceptance Criteria Category | Acceptance Criteria (Inferred/Implicit) | Reported Device Performance |
|---|---|---|
| Software Functionality | Software operates as intended and displays information accurately. | "Software testing" was performed, indicating the software functions were verified. |
| Instrument Equivalence | New instruments perform equivalently to previously cleared instruments. | "Comparative evaluations to demonstrate that the subject instruments are substantially equivalent to the predicate instruments used with NextAR Spine and cleared within K210859." |
| Surgical Suitability (Cadaver) | Instruments and system are adequate for intended surgical use. | "Cadaver workshops to demonstrate that the subject instruments are adequate for their intended use." |
| Tracking System Accuracy | The optical tracking system and fiducial registration maintain accuracy. | Stated as a shared characteristic with the predicate: "tracking system accuracy" and "fiducial registration accuracy" are maintained. No specific numerical thresholds or achieved performance reported in this document. |
| Biocompatibility | New instruments are biocompatible. | "The biocompatibility evaluation of the subject instruments leveraged identical materials and manufacturing to previously cleared instruments (K210859 and K200391)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of cases or subjects. "Cadaver workshops" imply surgical procedures performed on anatomical models (cadavers), but the number is not provided.
- Data Provenance: The document does not specify the country of origin for the cadaver studies or the software testing. The studies were non-clinical. The studies were likely prospective in nature, as they were "performed in support of a substantial equivalence determination."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the mention of "Cadaver workshops" suggests that surgeons or other qualified medical professionals would have been involved to assess the adequacy of the instruments and system for surgical use.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. Given that these were "cadaver workshops" to demonstrate adequacy, it's likely qualitative assessments by the participating surgeons, rather than a formal, multi-reader quantitative adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document explicitly states: "No clinical studies were conducted." This indicates that no MRMC study comparing human readers with and without AI assistance was performed. The device, NextAR™ Spine, is a surgical navigation platform, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies for reader performance improvement (e.g., radiologists interpreting images).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Not explicitly detailed with performance metrics. The "Software testing" and "Comparative evaluations" could be considered forms of standalone assessment of the algorithmic components and instrument performance, but no specific quantitative standalone performance (e.g., accuracy, precision) of the navigation algorithms themselves is provided in this summary. The device's primary function is as a navigation aid where a human surgeon is always in the loop.
7. Type of Ground Truth Used
- Type of Ground Truth:
- For instrument performance, the ground truth would likely be established through engineering specifications and comparative measurements against predicate instruments.
- For the cadaver workshops, the ground truth was likely surgical outcomes/adequacy as determined by the participating surgeons in a realistic (cadaveric) surgical environment. This is a form of expert assessment of functional performance. It is not pathology, or clinical outcomes data, as no clinical studies were performed.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document describes a traditional medical device (navigation system) with software components, not an AI/Machine Learning device that undergoes a train-test split methodology with large datasets for model training. The software functionality and instrument performance are verified through testing and comparative evaluation, not
ML model training on patient data.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not an AI/ML system requiring a dedicated training set with established ground truth in the typical sense for image interpretation or diagnosis. The "ground truth" for the device's functionality would stem from its design specifications, engineering principles, and the known anatomical relationships it aims to navigate.
In summary, the FDA 510(k) summary for NextAR™ Spine focuses on demonstrating substantial equivalence through non-clinical performance data, primarily through comparative evaluations with predicate devices and cadaveric workshops, rather than extensive clinical studies or AI model performance metrics.
§ 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).