Search Results

The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.

· XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.

· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.

· Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· Twitch Test (Train of Four) – The Twitch allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.

· SSEP = The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.

· Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System.

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.

This may include the following spinal implant procedures:

o Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine)

o Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral Approach)

The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a Patient Module (PM) and computer, as well as accompanying accessory components.

The Pulse NVM5 is a medical device that is intended for intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

Additionally, the Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in bending spinal rods (Bendini). Lastly, the Pulse NVM5 provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring.

LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging." LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.

LessRay System has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. LessRay System uses this information to aid the user in positioning the instrument.

Pulse Navigation is a stereotactic surgical application intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three dimensional space. The device provides real-time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in three dimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images can be either 2D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT).

The NuVasive Pulse System is comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The provided text details the indications for use and technological characteristics but lacks specific quantitative acceptance criteria or detailed study results for all components. However, it does mention nonclinical testing and a specific study related to the LessRay component.

Here's a breakdown of the requested information based on the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

For the LessRay image quality evaluation:

• Sample Size (Test Set): 30 image pairs.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

For the overall Pulse System nonclinical testing:

• Sample Size (Test Set): Not specified for each test.
• Data Provenance: Not specified beyond being "nonclinical testing." Cadaver validation implies ex-vivo data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the LessRay image quality evaluation:

• Number of Experts: Described as "a human observer." It's unclear if this was a single person or multiple individuals, and their qualifications are not provided (e.g., radiologist with X years of experience).

For other components of the Pulse System:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

For the LessRay image quality evaluation:

• Adjudication Method: "Side by side visual comparison." No mention of formal adjudication like 2+1 or 3+1.

For other components of the Pulse System:

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No explicit mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to measure how much human readers improve with AI vs. without AI assistance. The LessRay evaluation mentions "a human observer" comparing image pairs, which suggests a single observer, not an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The documentation mentions various software functionalities and algorithms (e.g., XLIF Detection, Basic & Dynamic Screw Test, LessRay's averaging algorithm, contrast/brightness enhancement). Nonclinical testing involved "software validation" and "tracking accuracy verification." This implies that standalone algorithm performance was assessed as part of the overall system validation, but specific results for the algorithm only (without human-in-the-loop) are not provided separately or in detail showing what performance was achieved for each algorithm.

7. The Type of Ground Truth Used

• For LessRay's image quality, the ground truth was based on a "human observer's" subjective visual perception of improved clarity, contrast, and noise level in comparison to unprocessed images.
• For the navigation components, "cadaver validation" was performed for 2D and 3D navigation for pedicle screw and interbody device placement, suggesting anatomical accuracy as a ground truth.
• For other components (NVM5 functionalities, tracking accuracy), the ground truth would likely be established through engineering measurements against design specifications and physical tests.

8. The Sample Size for the Training Set

• The document primarily describes validation and verification testing for regulatory submission (510(k)). It does not provide details on sample sizes for any training sets used for developing the algorithms within the Pulse System.

9. How the Ground Truth for the Training Set Was Established

• Since details on training sets are not provided, the method for establishing ground truth for training data is also not available in this document.

Ask a specific question about this device