(153 days)
The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation.
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 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 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 Test Function 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.
Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid 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 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:
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Pedicle Screw Placement (cervical, thoracic, lumbar)
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Iliosacral screw placement
The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a control unit, 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.
Pulse 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.
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 are in the form of 3D intraoperative scan (CT or Cone Beam CT).
The reason for this submission is to update indications for the Pulse Navigation application and to introduce design modifications to hardware and software components of the Navigation application.
The information provided describes a 510(k) premarket notification for the NuVasive Pulse System. The document focuses on demonstrating substantial equivalence to predicate devices rather than a direct study proving the device meets specific acceptance criteria in the way a clinical trial might. However, it does mention nonclinical testing and comparison points that serve as "acceptance criteria" for demonstrating substantial equivalence.
Here's an attempt to extract and structure the requested information based on the provided text, while noting the limitations of a 510(k) summary regarding detailed study designs:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a formal table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format for clinical outcomes. Instead, it states that the device was found "substantially equivalent" based on various nonclinical tests meeting product and software requirements specifications and showing equivalence to predicate devices. The closest to a performance metric is for LessRay's image quality improvement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| General | |
| Meets product and software requirements specifications | The subject Pulse System meets product and software requirements defined for the system. |
| Satisfies same acceptance criteria as predicate device performance | The subject Pulse System satisfies the same acceptance criteria as the performance of the predicate device. |
| Navigation Functionality | |
| Tracking accuracy verification per ASTM F2554-10 | Testing demonstrated compliance with ASTM F2554-10. |
| 3D navigation registration and tracking error verification | Testing successfully verified 3D navigation registration and tracking error. |
| Navigation software validation | Navigation software validation was successfully completed. |
| Cadaver validation for 3D navigation for pedicle screw placement | Cadaver validation for 3D navigation for pedicle screw placement was successfully completed. |
| Navigation system accuracy performance | The system's accuracy performance was demonstrated. |
| Electrical Safety and EMC | |
| Electrical safety and EMC testing per IEC 60601 | Testing demonstrated compliance with IEC 60601. |
| LessRay Image Enhancement | |
| Image quality improvement (clarity, contrast, noise, usability) | Improves the quality of noisy (low-quality) images, eliminating much of the graininess of low radiation dose images. (As evaluated by a human observer in a side-by-side visual comparison of 30 image pairs). |
2. Sample Size Used for the Test Set and Data Provenance
- LessRay Image Enhancement: A "side by side visual comparison of 30 image pairs with and without LessRay processing" was performed.
- Other tests (Tracking accuracy, 3D navigation registration, cadaver validation): The document does not specify the sample sizes for these test sets.
- Data Provenance: Not explicitly stated, but given the context of FDA submission, these would typically be internal company data from non-clinical lab settings, potentially using phantoms or cadavers. There is no mention of country of origin for the data or whether it was retrospective or prospective in detail, beyond being pre-market nonclinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- LessRay Image Enhancement: Evaluated by "a human observer." No specific number or qualifications of experts (e.g., radiologist with 10 years of experience) are provided beyond "human observer."
- Other tests: Not specified.
4. Adjudication Method for the Test Set
- Not specified for any of the tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study is not explicitly mentioned or detailed in this 510(k) summary. The evaluation for LessRay was a "side by side visual comparison of 30 image pairs" by "a human observer," which does not constitute a full MRMC study for comparative effectiveness with human readers with and without AI assistance. The focus is on demonstrating substantial equivalence rather than comparative effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the "Pulse System" as a medical device for intraoperative monitoring and navigation, implying human-in-the-loop operation.
- For LessRay, the "image quality improvement" assessment itself appears to be a standalone evaluation of the algorithm's output (processed image vs. unprocessed image) that is then visually evaluated by a human. However, this is not a diagnostic performance study of the algorithm providing a final interpretation without human intervention.
- The "Tracking accuracy verification" and "3D navigation registration and tracking error verification" would primarily assess the standalone technical performance of the algorithms.
7. The Type of Ground Truth Used
- LessRay Image Enhancement: The ground truth for "image quality improvement" appears to be subjective visual assessment by a human observer.
- Navigation / Tracking Accuracy: For "Tracking accuracy verification per ASTM F2554-10" and "3D navigation registration and tracking error verification," the ground truth would likely be established by precise measurements from a known reference standard (e.g., precise phantom coordinates, highly accurate measurement systems).
- Cadaver validation for 3D navigation for pedicle screw placement: The ground truth would involve confirmatory imaging (e.g., post-placement CT scans) and potentially dissection to verify pedicle screw placement relative to anatomical structures.
- Electrical safety and EMC: Ground truth would be adherence to established industry standards like IEC 60601.
8. The Sample Size for the Training Set
- The document is a 510(k) summary focused on substantial equivalence and nonclinical performance testing. It does not provide information on the training set size for any AI/algorithm components within the system (e.g., LessRay's enhancement algorithm or navigation algorithms).
9. How the Ground Truth for the Training Set Was Established
- Since information on the training set itself is not provided, the method for establishing its ground truth is also not detailed.
§ 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).