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The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either 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)
• · Iliosacral 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 NextARTM Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative 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.

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 aid the surgeon in executing the surgical plan by visualizing all the information in real time in 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 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 scan
• 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan .

NextAR gives the possibility of planning the screw positioning on the intraoperative DICOM images of the patient, in case of the 3D direct approach, just before the system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.

The NextAR Spine Platform includes also the rod planning that is intended to provide information on the length and geometry of the pre-bend rod that would fit with each screw position.

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 provided text describes the NextAR™ Spine Platform and its premarket notification (510(k)) to the FDA. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those acceptance criteria in the format requested (e.g., a table of acceptance criteria vs. reported performance).

The document states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." and lists the types of studies performed: "software validation; Accuracy test; performance testing; cadaver study." It clarifies that the differences between the new device and its predicate (rod planning and intraoperative screw planning features) "do not raise different questions of safety or effectiveness" and were addressed by "cadaveric testing/ rational/ test."

Based on the provided text, I can infer some general information about the performance evaluation but cannot fill in the requested table or specific details about the study outcomes beyond what is broadly mentioned.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study for NextAR™ Spine Platform

The provided FDA 510(k) summary for the NextAR™ Spine Platform states that testing was conducted according to written protocols with acceptance criteria based on standards. However, the specific, detailed acceptance criteria and a direct comparison to the "reported device performance" in a structured table are not present in this document. The document mentions "Accuracy test" as one of the performance evaluations, implying that accuracy was a key acceptance criterion, but the numerical targets and results are not provided.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document mentions "cadaver study."

• Sample Size for Test Set: Not specified. The exact number of cadavers or cases used in the cadaver study is not provided.
• Data Provenance: The cadaver study implies prospective data collection, but the geographical origin (country) is not specified. It is a laboratory/pre-clinical setting rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not provide details on how ground truth was established for the cadaver study or if experts were involved in a formal capacity for this purpose.

4. Adjudication method for the test set

Not specified. There is no mention of an adjudication method used for assessing the performance data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The NextAR™ Spine Platform is described as a surgical navigation platform (a "Stereotaxic Instrument") rather than an AI-driven image interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance (in the context of analyzing medical images) is not relevant to the described device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document mentions "Accuracy test" and "performance testing," which likely evaluate the system's inherent accuracy and functionality. However, it does not explicitly differentiate between standalone (algorithm-only) performance and human-in-the-loop performance. The device is a "computer-assisted surgical navigation platform," implying a human-in-the-loop scenario.

7. The type of ground truth used

For the "cadaver study," the ground truth would likely be established through precise measurements and potentially post-procedure imaging (e.g., CT scans of the cadaver with implanted screws) to verify the accuracy of the navigation system's guidance. The document does not explicitly state the method for establishing ground truth, but it would be based on anatomical references and surgical outcomes within the cadaver.

8. The sample size for the training set

Not applicable/Not specified. The document describes a navigation system, not a device primarily driven by machine learning model training on a large dataset of patient images. If any internal algorithms involved training, the size of such a training set is not specified.

9. How the ground truth for the training set was established

Not applicable/Not specified. As the document does not focus on machine learning model training, this information is not provided.

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