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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:

• Pedicle Screw Placement (cervical, thoracic, lumbar)
• Iliosacral screw placement

The subject device, Pulse ICT Adapter is introducing compatibility based on the design of existing fria patient reference hardware, the Spinous Process Clamp (Pulse System K210574) and Globus Medical 1CT Fixture (ExcelsiusGPS K171651 and K 191100). The subject device, Pulse ICT Adapter was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option by attaching Globus Medical Intra-Op CT Fixture to the following: existing Articulating Arm and Bedrail Clamp. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device is substantially equivalent to the predicate as demonstration and validation testing performed using well established and previously cleared test methods.

The Pulse System is a medical device consisting of 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 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 NVMS 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 utility 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 bendini). Lastry, the Pulse NVMS 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 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 to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in threedimensional 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 the submission is to introduce a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registation Fixture for the Pulse Navigation application.

The provided documentation (K243814) describes the NuVasive Pulse System (specifically, the Pulse ICT Adapter), a stereotaxic instrument for image-guided spinal surgery. The submission focuses on introducing a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registration Fixture for the Pulse Navigation application.

The document does not provide a comprehensive study proving the device meets specific acceptance criteria in the format requested (e.g., performance metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts). Instead, it focuses on demonstrating substantial equivalence to predicate devices through verification testing.

However, based on the information provided, we can infer some aspects related to acceptance criteria and the testing performed.

Here's an attempt to answer your questions based on the available text:

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

The document does not present a table of specific quantitative acceptance criteria or detailed performance results in the usual sense (e.g., sensitivity, specificity, accuracy for a diagnostic AI). Rather, it states that "the subject Pulse System meets product and software for the system and satisfies the same acceptance criteria as the predicate device."

The performance testing mentioned is primarily focused on verification and validation to ensure compliance with design specifications and user needs, particularly regarding tracking accuracy and usability.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" for a test set in terms of patient data or images (as would be common for AI/ML diagnostic devices). The testing described is non-clinical verification and validation. This would typically involve physical testing on phantoms or test setups rather than patient data.

• Sample Size: Not specified in terms of patient cases. The testing would be on a sufficient number of test samples/setups to prove the specific engineering requirements and standards.
• Data Provenance: Not applicable as it's non-clinical testing. The tests are performed in a laboratory/engineering environment.
• Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This document describes a surgical navigation system, not a diagnostic AI that interprets images. Therefore, the concept of "experts establishing ground truth for a test set" in the radiological interpretation sense does not apply directly.

The "ground truth" for a surgical navigation system's accuracy would be established through precise metrological measurements using phantoms or physical setups, not expert human agreement on medical images.

For usability testing (IEC 62366), "users" (e.g., simulated surgeons or clinical personnel) would interact with the device, and their feedback/performance would be assessed, but this is different from establishing a diagnostic ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this is not a study requiring expert adjudication of medical images.

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

No such MRMC study is described in this document. The device is a surgical navigation system, not an AI for image interpretation or a tool to assist human readers in diagnosis.

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

This also doesn't directly apply. The "algorithm" (Pulse Navigation) is inherently human-in-the-loop: it assists the surgeon. The "standalone" performance would be its tracking accuracy and computational correctness, which are assessed through the non-clinical verification as per ASTM F2554-10. The document states this testing was done to ensure the system meets its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the aspects of the device discussed (tracking accuracy, usability), the "ground truth" would be established by:

• Metrological standards: For tracking accuracy (e.g., using precise measurement tools and phantoms as per ASTM F2554-10). The true position would be known and deviations measured.
• Engineering specifications and user requirements: For general system functionality and safety.
• Usability engineering principles: For usability testing, where adherence to principles defined in standards like IEC 62366 is verified.

8. The sample size for the training set

This document does not describe an AI/ML device that undergoes a "training phase" on a dataset in the sense of deep learning or machine learning. The device is a hardware/software system that uses pre-defined algorithms for navigation and tracking. Therefore, there is no "training set" in the context of data-driven model learning.

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

Not applicable as there is no "training set" in the AI/ML sense. The system's algorithms are developed based on established engineering principles and physics.

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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:

• Pedicle Screw Placement (cervical, thoracic, lumbar)

• 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.

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.

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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.

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