Search Results

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.

Ask a specific question about this device

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

The NextAR Spine platform is intended to be used in combination with NextAR™Struments 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-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.

The provided document describes the FDA 510(k) clearance for the Medacta NextAR™ Spine Platform. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets and measured device performance in the format requested. Instead, it states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." It then lists the types of studies performed that would have generated data to demonstrate meeting these criteria.

However, based on the scope of the device (surgical navigation system for pedicle screw placement), the primary performance metric of interest for evaluating stereotaxic instruments is accuracy, specifically the deviation of the navigated instrument from the planned trajectory or anatomical landmark. While a specific numerical value for "accuracy" is mentioned as a shared characteristic with the predicate device, it is not explicitly quantified as an acceptance criterion in the provided text.

Inferred Information:

2. Sample Size for Test Set and Data Provenance

• Test Set (Cadaver Validation Study): The document states that a "cadaver validation study" was performed. However, it does not specify the sample size (e.g., number of cadavers, number of vertebrae, or number of screw placements) used for this study.
• Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer, Medacta International SA, is based in Switzerland, data could originate from there or other regions where testing facilities are available. It is a prospective study as it involves active testing on cadavers.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. For cadaveric studies involving screw placement, ground truth would typically be assessed by experienced surgeons or radiologists.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

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 related to human reader improvement with or without AI assistance. This type of study is more common for diagnostic AI tools and less directly applicable to a surgical navigation platform focused on physical precision.

6. Standalone (Algorithm Only) Performance Study

The document describes the NextAR™ Spine Platform as a surgical navigation platform that aids the surgeon. While it has algorithms for registration and visualization, its intended use is with a human in the loop. The "benchtop accuracy verification" and "cadaver validation study" would evaluate the system's performance, but it's not explicitly framed as a "standalone algorithm only" study in the sense of a diagnostic AI system without human input. The navigation software displays information to the surgeon, implying human interaction is integral.

7. Type of Ground Truth Used

For the "cadaver validation study," the ground truth would typically be established based on:

• Expert Consensus/Assessment: Post-procedure evaluation by surgeons or imaging specialists using high-resolution imaging (e.g., CT scans) to determine the actual trajectory and position of implanted screws relative to anatomical landmarks or intended trajectories.
• Imaging Data: Post-operative imaging (like CT scans) would be compared against the pre-operative plan and intra-operative navigation data to assess accuracy.

The document does not explicitly state the type of ground truth used, but these are standard practices for such studies.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. Surgical navigation systems like NextAR Spine typically rely on principles of image processing, stereotaxy, and 3D registration that are established algorithms, rather than deep learning models that require large proprietary training datasets in the same way an AI diagnostic tool would. If machine learning components are present, information on their training would be missing.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Ask a specific question about this device

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.

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.

Ask a specific question about this device