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.

AI/ML Overview

The provided text is a 510(k) summary for the LessRay® System. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain detailed information about acceptance criteria or specific study results demonstrating device performance against those criteria.

Specifically, the document states:

"Nonclinical testing was performed to demonstrate that the subject LessRay System is substantially equivalent to the predicate device."
"The results demonstrate that the subject LessRay System is substantially equivalent to the predicate."

However, it does not provide the acceptance criteria for these tests, nor the reported device performance against those criteria. It lists the types of tests performed:

Verification of Instrument Tracking
Verification of Alignment Accuracy
Verification of Image Registration Performance
Software Validation
Electrical Safety and Electromagnetic Compatibility (EMC) testing

Without access to the actual test reports or a more detailed summary of the performance studies, it's impossible to create the table and answer most of the specific questions.

Here's an analysis of what can be extracted or deduced from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Instrument Tracking Accuracy	Not Specified	Not Specified
Alignment Algorithm Performance	Not Specified	Not Specified
Image Registration Performance	Not Specified	Not Specified
Electrical Safety (IEC 60601-1)	Not Specified	Not Specified
Electromagnetic Compatibility (60601-1-2)	Not Specified	Not Specified

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any of the verifications. There is a note (footnote 1) mentioning "a side by side visual comparison of 30 image pairs with and without LessRay processing" by a human observer. It's unclear if this was part of the "Instrument Tracking," "Alignment Accuracy", or "Image Registration Performance" tests, or a separate informal assessment for image quality.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that the testing is "nonclinical," the data is likely not from human patients in a clinical setting but could be simulated, phantom, or animal data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Experts: Not specified for any of the verification tests.
Qualifications: Not specified.

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

Not specified.

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

A formal MRMC comparative effectiveness study is not mentioned. Footnote 1 refers to a "side by side visual comparison of 30 image pairs with and without LessRay processing" by a "human observer," but this does not constitute an MRMC study and no "effect size" is reported. The focus of the reported "nonclinical testing" seems to be on the technical performance of the features (tracking, alignment, registration) rather than clinical effectiveness with human readers.

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

The mentioned "Verification of Instrument Tracking," "Verification of Alignment Accuracy," and "Verification of Image Registration Performance" tests are likely standalone algorithm performance assessments. However, the details of these tests (e.g., how accuracy was measured, what metrics were used) are not provided.

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

Not specified for any of the verification tests. For "Instrument Tracking," "Alignment Accuracy," and "Image Registration," the ground truth would likely be a precisely measured or known physical position/alignment/transformation.

8. The sample size for the training set

The document describes the LessRay System as utilizing "averaging algorithm" and "contrast and brightness enhancement." This suggests traditional image processing algorithms rather than deep learning or machine learning models that typically require a distinct "training set." Therefore, a "training set sample size" is likely not applicable in the context of the described algorithms. If there were machine learning components, no details are provided.

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

As a training set is likely not applicable (see point 8), this information is not provided.

In summary: The 510(k) summary indicates that nonclinical testing was performed to demonstrate substantial equivalence, but it lacks the specific details regarding acceptance criteria, quantitative performance results, sample sizes, ground truth establishment, and reader study information that would be necessary to fully answer the request. The document appears to focus on demonstrating the technical functionality and safety of the device's new features (instrument tracking, wired remote) in comparison to its predicates, rather than providing detailed clinical efficacy data.

Summary

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November 16, 2017

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

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

Re: K173314

Trade/Device Name: LessRay® System Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ, and JAA Dated: October 17, 2017 Received: October 19, 2017

Dear Manthan Damani:

We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

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)

K173314

Device Name LessRay® System

Indications for Use (Describe)

LessRay® System 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is split into two parts, with the top part being purple and the bottom part being gray.

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: October 17, 2017

B. Device Name

Trade or Proprietary Name:	LessRay® System
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

Predicate Devices C.

The subject device is substantially equivalent to the predicate devices LessRay® with Tracking (K142243) and LessRay® with Enhanced Tracking (K170800).

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 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.

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Image /page/4/Picture/0 description: The image shows the logo for NuVasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in capital letters to the right of the leaf. The leaf is colored purple on the top and gray on the bottom. The word "NUVASIVE" is gray.

The purpose of this premarket notification is addition of a wired remote to the LessRay System and the integration of instrument tracking functionality previously cleared in K170800.

LessRay System is designed per recommendations provided in the following FDA guidance documents:

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

Indications for Use E.

LessRay® System 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 LessRay System 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)	Predicate DeviceNuVasive LessRay withEnhanced Tracking(K170800)	Subject DeviceLessRay System	Discussion
Intended Use /Indications forUse	LessRay® with Tracking isintended for use in anyapplication where afluoroscope is incorporatedto aid in diagnosis andtreatment of disease.	NuVasive® LessRay® withEnhanced Tracking isintended for use in anyapplication where afluoroscope is incorporatedto aid in diagnosis andtreatment of disease.	LessRay® System isintended for use in anyapplication where afluoroscope isincorporated to aid indiagnosis and treatmentof disease.	Same
DeviceClass	II	II	II	Same
Product Code	OWB, JAA, LLZ	OWB, JAA, LLZ	OWB, JAA, LLZ	Same
RegulationNumber(21CFR)	§892.1650	§892.1650	§892.1650	Same
DeviceClassificationName	Interventional FluoroscopicX-Ray System	Interventional FluoroscopicX-Ray System	InterventionalFluoroscopic X-RaySystem	Same
Specification/Property	Predicate DeviceLessRay with Tracking(K142243)	Predicate DeviceNuVasive LessRay withEnhanced Tracking(K170800)	Subject DeviceLessRay System	Discussion
DeviceFunctionalities(imageacquisition,enhancement,anddisplay)	Software based deviceused to provide computerdisplay systems interfacedto a fluoroscope through avideo cable. Imagesproduced by fluoroscopeare transmitted through acable to a frame captureboard in computer whereimages are enhanced andthen displayed on themonitor.Enhanced images aredisplayed on computermonitor at the same timethat corresponding originalimage is displayed onfluoroscope monitor(s).Uses software to controlframe capture,intermediate imagemanipulation, and imagedisplay.Delay between frameacquisition and framedisplay is less than thetime between frames, i.e.33 msec.Serves only as an imagedisplay which is inaddition to thefluoroscope's standardimage display device.Device is passive, in thatthe operation depends onlyon the video output of thefluoroscope, and it doesnot transmit any signals orimages to the fluoroscope.	Software based device usedto provide computerdisplay systems interfacedto a fluoroscope through avideo cable. Imagesproduced by fluoroscopeare transmitted through acable to a frame captureboard in computer whereimages are enhanced andthen displayed on themonitor.Enhanced images aredisplayed on computermonitor at the same timethat corresponding originalimage is displayed onfluoroscope monitor(s).Uses software to controlframe capture, intermediateimage manipulation, andimage display.Delay between frameacquisition and framedisplay is less than the timebetween frames, i.e. 33msec.Serves only as an imagedisplay which is in additionto the fluoroscope'sstandard image displaydevice. Device is passive,in that the operationdepends only on the videooutput of the fluoroscope,and it does not transmit anysignals or images to thefluoroscope.	Software based deviceused to providecomputer displaysystems interfaced to afluoroscope through avideo cable. Imagesproduced byfluoroscope aretransmitted through acable to a frame captureboard in computerwhere images areenhanced and thendisplayed on themonitor.Enhanced images aredisplayed on computermonitor at the sametime that correspondingoriginal image isdisplayed onfluoroscope monitor(s).Uses software tocontrol frame capture,intermediate imagemanipulation, andimage display.Delay between frameacquisition and framedisplay is less than thetime between frames,i.e. 33 msec.Serves only as animage display which isin addition to thefluoroscope's standardimage display device.Device is passive, inthat the operationdepends only on thevideo output of thefluoroscope, and itdoes not transmit anysignals or images tothe fluoroscope.	Same
		Page 3 of 6
Specification/Property	Predicate DeviceLessRay with Tracking(K142243)	Predicate DeviceNuVasive LessRay withEnhanced Tracking(K170800)	Subject DeviceLessRay System	Discussion
Algorithms	- Image qualityimprovement usingaveraging algorithm- Contrast and brightnessenhancement withsimultaneous reductionof random noise	- Image qualityimprovement usingaveraging algorithm- Contrast and brightnessenhancement withsimultaneous reduction ofrandom noise	- Image qualityimprovement usingaveraging algorithm- Contrast and brightnessenhancement withsimultaneous reductionof random noise	Same
C-armTracking	- When tracking isenabled, willautomatically choose theBaseline when thefluoroscope is near thelocation and orientationthat the Baseline wasinitially taken.- When tracking isenabled, requireshardware components inorder to mount the off-the-shelf trackinghardware to the C-armand to the operatingtable.- When tracking isenabled, requires the useof an off-the-shelftracking system in orderto track the 6 DOFlocation of the C-armrelative to the operatingtable.- When tracking isenabled, visual cues areprovided which helpguide the user inpositioning the C-armback to where a priorBaseline was taken.	- When tracking is enabled,will automatically choosethe Baseline when thefluoroscope is near thelocation and orientationthat the Baseline wasinitially taken.- When tracking is enabled,requires hardwarecomponents in order tomount the off-the-shelftracking hardware to theC-arm and to theoperating table.- When tracking is enabled,requires the use of an off-the-shelf tracking systemin order to track the 6DOF location of the C-arm relative to theoperating table.- When tracking is enabled,visual cues are providedwhich help guide the userin positioning the C-armback to where a priorBaseline was taken.	- When tracking isenabled, willautomatically choosethe Baseline when thefluoroscope is near thelocation andorientation that theBaseline was initiallytaken.- When tracking isenabled, requireshardware componentsin order to mount theoff-the-shelf trackinghardware to the C-armand to the operatingtable.- When tracking isenabled, requires theuse of an off-the-shelftracking system inorder to track the 6DOF location of theC-arm relative to theoperating table.- When tracking isenabled, visual cuesare provided whichhelp guide the user inpositioning the C-armback to where a priorBaseline was taken.	Same
Trackingoptions	Electromagnetic or optical	Electromagnetic or optical	Optical	Same
Specification/Property	Predicate DeviceLessRay with Tracking(K142243)	Predicate DeviceNuVasive LessRay withEnhanced Tracking(K170800)	Subject DeviceLessRay System	Discussion
Compatiblehardwareplatforms	Any computer that meetsthe following minimumspecifications:CPU: Intel Core 2 DuoGPU: NVIDIA Quadro4000RAM: 8 GBHDD: 256 GBFrame Grabber: Aver MediaH339 or ElgatoOperating System:Windows 7 or 8.1	Any computer that meets thefollowing minimumspecifications:CPU: Intel Core 2 DuoGPU: NVIDIA Quadro 4000RAM: 8 GBHDD: 256 GBFrame Grabber: Aver MediaH339 or ElgatoOperating System: Windows8.1	LessRay computerspecifications:CPU: Intel Core 2 DuoGPU: NVIDIA Quadro4000RAM: 8 GBHDD: 256 GBFrame Grabber: AverMedia H339 or ElgatoOperating System:Windows 8.1	Same
InstrumentTracking	No	Yes- NuVasive LessRaywith Enhanced Tracking hasadditional capability ofinstrument tracking to aid theuser in positioning aninstrument using priorbaseline x-rays.	Yes- LessRay System hasadditional capability ofinstrument tracking to aidthe user in positioning aninstrument using priorbaseline x-rays.	Same

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Image /page/5/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in a sans-serif font to the right. The leaf shape is divided into two parts, with the top part in purple and the bottom part in gray. The word "NUVASIVE" is in gray.

Traditional 510(k) Submission NuVasive® LessRay® System

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Traditional 510(k) Submission NuVasive® LessRay® System

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Image /page/7/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left and the word "NUVASIVE" on the right. The leaf shape is divided into two parts, with the top part being purple and the bottom part being gray. The word "NUVASIVE" is written in a simple, sans-serif font and is also gray.

Traditional 510(k) Submission Nu Vasive® LessRay® System

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject LessRay System is substantially equivalent to the predicate device. The following testing was performed:

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 Alignment Accuracy to confirm that the alignment algorithm performs ● according to specifications.
Verification of Image Registration Performance to confirm that the software performs ● image registration according to specifications.
Software Validation to validate the functionality and user operations of LessRay System.
Electrical Safety and Electromagnetic Compatibility (EMC) testing of LessRay ● System per IEC 60601-1 and IEC 60601-1-2 respectively.

The results demonstrate that the subject LessRay System is substantially equivalent to the predicate.

H. Conclusions

The subject LessRay System has been shown to be substantially equivalent to legally marketed predicate devices for their intended use.

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Image /page/8/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left and the word "NUVASIVE" on the right. The leaf shape is split into two colors, with the top portion being purple and the bottom portion being gray. The word "NUVASIVE" is written in gray, sans-serif font.

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.