NuVasive® LessRay® with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Device Description

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 with Tracking provided 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.

NuVasive LessRay with Enhanced Tracking 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. NuVasive LessRay with Enhanced Tracking uses this information to aid the user in positioning the instrument.

AI/ML Overview

The NuVasive® LessRay® with Enhanced Tracking device is intended for use in fluoroscopic applications to aid in diagnosis and treatment. The study performed focuses on the new "Enhanced Tracking" feature which aids in instrument positioning.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, the performance claims for the "Enhanced Tracking" functionality are described qualitatively. Based on the provided text, here’s a representation of the acceptance criteria and the claimed performance:

Acceptance Criteria (Implied)	Reported Device Performance
Instrument Tracking (Relocalization Ability): Allow the user to reposition an instrument to a previously identified location.	Confirmed through Verification of Instrument Tracking.
GUI Functionality: Graphical User Interface performs according to specifications.	Confirmed through Verification of Graphical User Interface (GUI).
Clinical Efficiency (Relocalization): Instruments can be relocalized with fewer X-ray images.	Confirmed through Validation of Instrument Tracking.
Accuracy (Relocalization): Instruments can be relocalized with greater accuracy.	Confirmed through Validation of Instrument Tracking.
Time Efficiency (Relocalization): Instruments can be relocalized in less time than conventional fluoroscopy.	Confirmed through Validation of Instrument Tracking.
Core Functionalities (Regression): Maintain image alignment, glyph tracking, and image registration performance.	Confirmed through Regression Testing.

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

The document does not specify the sample size for any of the test sets used for verification or validation of the Enhanced Tracking feature. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned.

3. Number of Experts and Qualifications

The document does not mention the number or qualifications of experts used to establish a ground truth for the test set related to the "Enhanced Tracking" feature.

(Note: Footnote 1 refers to a "side by side visual comparison of 30 image pairs with and without LessRay processing" for evaluating image quality improvement, but this appears to be related to the original LessRay functionality and not specifically the new Enhanced Tracking feature. It also doesn't specify experts or their qualifications for this particular evaluation).

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set used for the Enhanced Tracking feature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is explicitly described for the "Enhanced Tracking" feature.

6. Standalone Performance

The performance data are described for the "Enhanced Tracking" functionality, indicating the capabilities of the algorithm in aiding instrument positioning. The validation focuses on the device's ability to help users achieve specific outcomes (fewer X-rays, greater accuracy, less time). While it describes the performance of the device's feature, it's not a standalone performance study in the sense of an algorithm making a diagnostic decision by itself without human input, as the device is designed to aid the user.

7. Type of Ground Truth

The document doesn't explicitly state the type of ground truth used for the verification and validation of the "Enhanced Tracking" feature. Given the nature of the evaluation (positioning an instrument), the "ground truth" would likely be derived from:

Physical measurements/known states: For verifying the accuracy of instrument tracking systems against known positions.
Procedural compliance/expert observation: For validating that the GUI performs as intended and that the instrument can be consistently relocalized.
Observed outcomes: For validating reduced X-ray images, improved accuracy, and reduced time.

8. Sample Size for the Training Set

The document does not mention any training set or its sample size. This suggests that the "Enhanced Tracking" feature is likely based on engineered algorithms or heuristics rather than machine learning models that require a distinct training phase with labeled data.

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

As no training set is mentioned, the method for establishing its ground truth is also not described.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2017

NuVasive, Incorporated % Manthan Damani Senior Regulatory Affairs Specialist 7475 Lusk Boulevard SAN DIEGO CA 92121

Re: K170800

Trade/Device Name: NuVasive® LessRay® with Enhanced Tracking Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ and JAA Dated: July 25, 2017 Received: July 26, 2017

Dear Manthan Damani:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170800

Device Name

NuVasive® LessRay® with Enhanced Tracking

Indications for Use (Describe)

NuVasive® LessRay® with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Manthan J. Damani Senior Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: August 17, 2017

B. Device Name

Trade or Proprietary Name:	NuVasive® LessRay® with Enhanced Tracking
Common or Usual Name:	Image processing system
Classification Name:	Image-intensified fluoroscopic x-ray system
Device Class:	Class II
Classification:	21 CFR § 892.1650
Product Code:	OWB, LLZ, JAA

C. Predicate Devices

The subject device is substantially equivalent to the predicate device LessRay® with Tracking (K142243).

D. Device Description

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.2 LessRay with Tracking provided 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.

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NuVasive LessRay with Enhanced Tracking is designed per recommendations provided in the following FDA guidance documents:

Guidance for the Content of Premarket Submissions for Software Contained in ● Medical Devices
Off-The-Shelf Software Use in Medical Devices ●
Content of Premarket Submissions for Management of Cybersecurity in Medical ● Devices

Indications for Use E.

NuVasive® LessRay® with Enhanced Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

F. Comparison of Technological Characteristics with Predicate Device

As was established in this submission, the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent to its predicate device through comparison in areas including design, labeling/intended use, and function.

Specification/Property	Predicate DeviceLessRay with Tracking (K142243)	Subject DeviceNuVasive LessRay with EnhancedTracking	Discussion
Intended Use/ Indicationsfor Use	LessRay® with Tracking is intended foruse in any application where afluoroscope is incorporated to aid indiagnosis and treatment of disease.	NuVasive® LessRay® with EnhancedTracking is intended for use in anyapplication where a fluoroscope isincorporated to aid in diagnosis andtreatment of disease.	Same
Device Class	II	II	Same
Product Code	OWB, JAA, LLZ	OWB, JAA, LLZ	Same
RegulationNumber(21CFR)	§892.1650	§892.1650	Same
DeviceClassificationName	Interventional Fluoroscopic X-RaySystem	Interventional Fluoroscopic X-RaySystem	Same
Specification / Property	Predicate DeviceLessRay with Tracking (K142243)	Subject DeviceNuVasive LessRay with Enhanced Tracking	Discussion
DeviceFunctionalities (imageacquisition, enhancement,and display)	- Software based device used toprovide computer display systemsinterfaced to a fluoroscope througha video cable. The imagesproduced by the fluoroscope aretransmitted through a cable to aframe capture board in thecomputer where the images areenhanced and then displayed on themonitor.- Enhanced images are displayed ona computer monitor at the sametime that the correspondingoriginal image is displayed on thefluoroscope monitor(s).- Serves only as an image displaywhich is in addition to thefluoroscope's standard imagedisplay device. Device is passive,in that the operation depends onlyon the video output of thefluoroscope, and it does nottransmit any signals or images tothe fluoroscope.	- Software based device used toprovide computer display systemsinterfaced to fluoroscope through avideo cable. The images producedby the fluoroscope are transmittedthrough a cable to a frame captureboard in the computer where theimages are enhanced and thendisplayed on the monitor.- Enhanced images are displayed ona computer monitor at the sametime that the correspondingoriginal image is displayed on thefluoroscope monitor(s).- Serves only as an image displaywhich is in addition to thefluoroscope's standard imagedisplay device. Device is passive,in that the operation depends onlyon the video output of thefluoroscope, and it does nottransmit any signals or images tothe fluoroscope.	Same
Algorithms	- Image quality improvement usingaveraging algorithm- Contrast and brightnessenhancement with simultaneousreduction of random noise	- Image quality improvement usingaveraging algorithm- Contrast and brightness enhancementwith simultaneous reduction ofrandom noise	Same
Compatiblehardwareplatforms	Any computer that meets the followingminimum specifications:CPU: Intel Core 2 DuoGPU: NVIDIA Quadro 4000RAM: 8 GBHDD: 256 GBFrame Grabber: Aver Media H339 orElgatoOperating System: Windows 7 or 8.1	Any computer that meets the followingminimum specifications:CPU: Intel Core 2 DuoGPU: NVIDIA Quadro 4000RAM: 8 GBHDD: 256 GBFrame Grabber: Aver Media H339 orElgatoOperating System: Windows 7 or 8.1	Same
Specification / Property	Predicate DeviceLessRay with Tracking (K142243)	Subject DeviceNuVasive LessRay with EnhancedTracking	Discussion
C-armTracking	- When tracking is enabled, willautomatically choose the Baselinewhen the fluoroscope is near thelocation and orientation that theBaseline was initially taken.- When tracking is enabled, requires	- When tracking is enabled, willautomatically choose the Baselinewhen the fluoroscope is near thelocation and orientation that theBaseline was initially taken.- When tracking is enabled, requires	Same
	hardware components in order tomount the off-the-shelf trackinghardware to the C-arm and to theoperating table.	hardware components in order tomount the off-the-shelf trackinghardware to the C-arm and to theoperating table.
	- When tracking is enabled, requiresthe use of an off-the-shelf trackingsystem in order to track the 6 DOFlocation of the C-arm relative to theoperating table.	- When tracking is enabled, requiresthe use of an off-the-shelf trackingsystem in order to track the 6 DOFlocation of the C-arm relative to theoperating table.
	- When tracking is enabled, visualcues are provided which help guidethe user in positioning the C-armback to where a prior Baseline wastaken.	- When tracking is enabled, visualcues are provided which help guidethe user in positioning the C-armback to where a prior Baseline wastaken.
Trackingoptions	Electromagnetic or optical	Electromagnetic or optical	Same

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Speci

Traditional 510(k) Submission NuVasive® LessRay® with Enhanced Tracking

G. Performance Data

Instrument

Tracking

Nonclinical testing was performed to demonstrate that the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to the predicate device. The following testing was performed:

Enhanced Tracking has additional

capability of instrument tracking to aid

the user in positioning an instrument

using prior baseline x-rays.

. Verification of Instrument Tracking to confirm that subject device allows the user to position the instrument back to where it was located when the desired image is taken.
Verification of Graphical User Interface (GUI) to confirm that the GUI performs ● according to specifications.
Validation of Instrument Tracking to confirm that using subject device instruments ● can be relocalized with less number of x-ray images, greater accuracy, and less time than when using conventional fluoroscopy.

Additio

nal

function

ality

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Regression Testing to verify image alignment, glyph tracking, and image registration . performance functionalities.
The results demonstrate that the subject NuVasive LessRay with Enhanced Tracking is substantially equivalent to the predicate.

H. Conclusions

The subject NuVasive LessRay with Enhanced Tracking has been shown to be substantially equivalent to legally marketed predicate devices for their intended use.

1 As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing.

2 In clinical practice, the amount of improvement achieved when a Pulsed and/or Low Dose image is processed with LessRay is dependent on the clinical task, patient size, anatomical location, and clinical practice. The dose should be set at a level to which the physician is able to achieve the adequate image quality needed for the particular clinical task. A consultation with a radiologist and a physicist may aid in determining the appropriate dose settings.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.