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® works by combining the current image being taken with a prior "Baseline" image of the same anatomy. The initial image, taken at regular radiation dose settings, serves as a baseline to which images taken at lower dose radiation settings can be compared and enhanced. In procedures where instruments are introduced into the field of view, LessRay® images provide information that is not available with conventional images. By merging an image of interest containing tools with the unencumbered Baseline image, the radio dense metallic tools and implants that obscure the underlying anatomy can be rendered partially translucent in the merged image. In addition, by alternating the new image with the Baseline a user can make these metallic tools or implants disappear and reappear from the image, revealing the anatomy blocked by the tool. The subject of this 510(k) is the addition of tracking capability to be used with LessRay LessRay can be interfaced 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.

AI/ML Overview

The provided document is a 510(k) summary for the LessRay with Tracking device. It primarily focuses on demonstrating substantial equivalence to a predicate device (LessRay®) and details performance testing related to the tracking features, rather than image enhancement performance in a clinical context with acceptance criteria for diagnostic accuracy.

Therefore, the information required to populate all sections of your request (especially regarding acceptance criteria and a study proving image processing performance meets these criteria, ground truth specifics, multi-reader multi-case studies, and human reader improvement) is not fully available in this document. The document explicitly states that the substantial equivalence is for the addition of tracking capability.

However, I can extract what is available regarding the device's performance related to the image enhancement aspect and the tracking feature.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide explicit numerical "acceptance criteria" for the image enhancement capabilities or a study demonstrating the device meets a specific clinical performance metric. Instead, it describes general improvements and relies on substantial equivalence to a predicate device. For the tracking functionality, the "acceptance criteria" are implied by the performance tests conducted.

Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Image Enhancement	Improve clarity, contrast, noise level, and usability of noisy (low-quality) low radiation dose images.	"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."
	Provide information not available with conventional images during procedures with instruments.	"By merging an image of interest containing tools with the unencumbered Baseline image, the radio dense metallic tools and implants that obscure the underlying anatomy can be rendered partially translucent in the merged image."
	Allow metallic tools/implants to disappear/reappear to reveal underlying anatomy.	"by alternating the new image with the Baseline a user can make these metallic tools or implants disappear and reappear from the image, revealing the anatomy blocked by the tool."
Tracking Functionality	Verification of Glyph Tracking	Performed. (Specific performance metrics not detailed, but states "Verification of Glyph Tracking" was a test).
	Tracking Accuracy with NDI Vicra Optical Tracking System	Performed. (Specific performance metrics not detailed, but states "Tracking Accuracy with the NDI Vicra Optical Tracking System" was a test).
	Tracking Accuracy with Patriot M Electromagnetic Tracking System	Performed. (Specific performance metrics not detailed, but states "Tracking Accuracy with the Patriot M Electromagnetic Tracking System" was a test).
	Tracking Accuracy with Patriot M EMS and Dynamic Metal Distortion	Performed. (Specific performance metrics not detailed, but states "Tracking Accuracy with the Patriot M Electromagnetic Tracking System and Dynamic Metal Distortion" was a test).
	Fluoroscope Navigation Validation	Performed. (Specific performance metrics not detailed, but states "Validation of Fluoroscope Navigation" was a test).
Software Regression/Image Recognition	Behavior consistent with predicate device.	"Regression/Image Recognition Compared to LessRay v1.0" was performed. (Implies consistency with prior version).

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

Image Enhancement / Regression Testing: "a side by side visual comparison of 30 image pairs with and without LessRay processing."
Tracking Functionality: The document lists several tests for tracking (Glyph Tracking, NDI Vicra, Patriot M, Patriot M with Dynamic Metal Distortion, Fluoroscope Navigation Validation). It does not specify the sample size (e.g., number of tracking instances, number of trials) for these tests.
Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

Image Enhancement: "As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing." Only one human observer is explicitly mentioned. No qualifications for this observer are provided.
Tracking Functionality: Not specified. The nature of these tests suggests they might be engineering or bench performance tests rather than clinical expert evaluation.

4. Adjudication Method for the Test Set

Image Enhancement: Based on "a human observer in a side by side visual comparison," there does not appear to be an adjudication method (like 2+1 or 3+1 consensus) described. It seems to be a single observer's assessment.
Tracking Functionality: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done as described in the provided text for the image enhancement features. Only a single human observer is mentioned.
The document focuses on "substantial equivalence" based on similar technological characteristics and performance tests, not clinical comparative effectiveness in terms of human reader performance with or without AI assistance.
Effect Size: Not applicable, as no such study was performed or reported here.

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

The document implies that the image processing itself is an algorithm-only function that enhances the image before display to a human. The "Regression/Image Recognition Compared to LessRay v1.0" test could be considered a standalone evaluation of the algorithm's output consistency.
The performance tests for tracking accuracy (e.g., with NDI Vicra or Patriot M systems) are likely standalone technical evaluations of the tracking functionality itself, without direct human intervention as part of the performance measurement.

7. The Type of Ground Truth Used

Image Enhancement: For the "human observer" evaluation, the "ground truth" is subjective human judgment of image quality (clarity, contrast, noise level, usability) by that single observer.
Tracking Functionality: The ground truth for tracking accuracy tests would implicitly be the known, precise positions or movements of the C-arm or markers as measured by the optical or electromagnetic tracking systems themselves, or a known spatial relationship being correctly identified.

8. The Sample Size for the Training Set

The document does not mention a training set for the image enhancement algorithm(s) or the tracking software. This document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed technical report on algorithm development. The core image enhancement algorithm (summation of prior full dose images) seems to be based on a fixed logic rather than a machine learning model that requires a training set.

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

Not applicable, as no training set is described in the document.

Summary

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

November 18, 2014

SafeRay Spine, LLC % Ms. Calley Herzog Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314

Re: K142243

Trade/Device Name: LessRay with Tracking Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, LLZ Dated: October 17, 2014 Received: October 20, 2014

Dear Ms. Herzog:

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 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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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/Resourcesfor You/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 yours,

Robert A Ochs

for

Janine M. Morris 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) K142243

Device Name LessRay® with Tracking

Indications for Use (Describe)

LessRay® with 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)

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 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the LessRay with Tracking is provided below.

Device Common Name:	Image Processing System
Device Proprietary Name:	LessRay® with Tracking
Submitter:	SafeRay Spine, LLC5102 Durham Chapel Hill Blvd., Suite 203Durham, NC 27707Phone: 877-814-7509
Contact:	Calley HerzogConsultantBiologics Consulting Group, Inc.Phone: 720-883-3633Fax: 703-548-7457Email: cherzog@bcg-usa.com
Classification Regulation:	21 CFR 892.1650, Class II
Classification Name:	Image-intensified fluoroscopic x-ray system
Panel:	Radiology
Primary Product Code:	OWB - interventional fluoroscopic x-ray system
Secondary Product Codes:	LLZ - system, image processing, radiologicalJAA – system, x-ray, fluoroscopic, image-intensified
Date Prepared:	October 17, 2014
Predicate Device:	K132970, LessRay®

Indication for Use:

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

Device Description:

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LessRay® works by combining the current image being taken with a prior "Baseline" image of the same anatomy. The initial image, taken at regular radiation dose settings, serves as a baseline to which images taken at lower dose radiation settings can be compared and enhanced.

In procedures where instruments are introduced into the field of view, LessRay® images provide information that is not available with conventional images. By merging an image of interest containing tools with the unencumbered Baseline image, the radio dense metallic tools and implants that obscure the underlying anatomy can be rendered partially translucent in the merged image. In addition, by alternating the new image with the Baseline a user can make these metallic tools or implants disappear and reappear from the image, revealing the anatomy blocked by the tool.

The subject of this 510(k) is the addition of tracking capability to be used with LessRay LessRay can be interfaced 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.

Performance Data:

To establish the substantial equivalence of the modified LessRay® with Tracking to the predicate LessRay® device, the following performance tests were performed:

Regression/Image Recognition Compared to LessRay v1.0 ●
Verification of Glyph Tracking
Tracking Accuracy with the NDI Vicra Optical Tracking System ●
Tracking Accuracy with the Patriot M Electromagnetic Tracking System
Tracking Accuracy with the Patriot M Electromagnetic Tracking System and Dynamic Metal Distortion
. Collar Assembly Vertical Pull-Off Safety Test
Validation of Fluoroscope Navigation

Substantial Equivalence:

Based on the identical indication, similar technological characteristics, and results of performance testing, LessRay with Tracking is substantially equivalent to the previously cleared LessRay® device (K123226).

	Proposed Device	Predicate Device
510(k) Number	K142243	K132970
Device Name	LessRay® with Tracking	LessRay®
Submitter	SafeRay Spine, LLC	SafeRay Spine, LLC
Classification Regulation	892.1650	892.1650
Product Code	OWB, LLZ	OWB, LLZ

Table 1: Device Comparison Table

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	Proposed Device	Predicate Device
Indication	Indicated for use in anyapplication where a fluoroscopeis incorporated to aid in diagnosisand treatment of disease.	Indicated for use in anyapplication where a fluoroscopeis incorporated to aid in diagnosisand treatment of disease.
Compatible HardwarePlatforms	Any computer that meets thefollowing minimumspecifications:CPU: Intel Core 2 DuoGPU: NVIDIA Quadro 4000RAM: 8 GBHDD: 256 GBFrame Grabber: Aver MediaH339 or ElgatoOperating System: Windows 7 or8.1	Any computer that meets thefollowing minimumspecifications:CPU: Intel Core 2 DuoGPU: NVIDIA Quadro 4000RAM: 8 GBHDD: 256 GBFrame Grabber: Aver MediaH339 or ElgatoOperating System: Windows 7 or8.1
Software is run on a stand-alone computer and monitor	Yes	Yes
Device is passive and doesn'tcontrol the fluoroscope	Yes	Yes
Displays reduced noise images	Yes	Yes
For use during procedures thatinvolve fluoroscopy	Yes	Yes
Improves quality of low doseimages	Yes	Yes
Uses data from prior images toimprove the quality ofsubsequent images	Yes	Yes
Algorithm used to improveimage quality	Summation of prior full doseimages with subsequent images	Summation of prior full doseimages with subsequent images
Provides visual cues which helpguide the user in positioningthe C-arm back to where aprior Baseline was taken.	Yes	No
Automatically selects thenearest Baseline as the C-armis being moved.	Yes	No
Requires a 6 DOF trackingsystem in some configurations.	Yes	No

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	Proposed Device	Predicate Device
Requires mounting hardwareused to mount the 6 DOFtracking system to the C-armand the operating table.	Yes	No

Substantial Equivalence Summary

The addition of the optional tracking feature does not change the intended use of the device as a software application that enhances images from a fluoroscope. LessRay with Tracking provides the additional capability of aiding the user in acquiring fluoroscopic images by ensuring that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images. The performance testing demonstrated substantial equivalence of LessRay with Tracking to the previously cleared LessRay device. Therefore, based on the identical indication, similar technological characteristics, and results of performance testing, LessRay® with Tracking is substantially equivalent to LessRay® as it was cleared in K123226 and K132970.

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

4 In clinical practice, the amount of image quality 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.