I.essRay* is a software only device that is used to enhance the utility of low dose images by comparing them to a baseline image taken at a regular dose setting. A computer running LessRay" is interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the monitor of the computer running LessRay®. Each image is displayed by LessRay at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).

AI/ML Overview

The provided text describes a 510(k) summary for the LessRay® device, which is a software-only device designed to enhance low-dose fluoroscopic images. However, the submission K132970 is about a modification to a previously cleared device (K123226). The modification entails providing the software on a CD for user installation, rather than preloaded on a computer.

Crucially, the document explicitly states: "These modifications represent a minor device modification and do not affect the indications for use. To assess the impact of this change a risk analysis was conducted. Based on the risk analysis verification testing was performed to ensure proper functioning of the software on four computer platforms."

This means the performance data provided in this submission (K132970) focuses on the software's functionality on different hardware platforms after the modification, not on the clinical performance or effectiveness of the image enhancement algorithm itself. The clinical effectiveness and acceptance criteria for the image enhancement would have been part of the original 510(k) submission (K123226), which is not fully detailed here. Therefore, many of the requested details about acceptance criteria, sample sizes for test sets, expert qualifications, and ground truth for clinical performance cannot be extracted from this specific document.

The document states: "The algorithm used and the user experience are identical to that of the previously cleared version." and "Algorithm used to improve image quality - NO CHANGE from K123226". This implies that the clinical performance evaluation was done for K123226 and is considered unchanged.

Here's what can be extracted from the provided text for K132970, focusing on the modification rather than the original clinical performance:

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

For K132970, the acceptance criteria and performance relate to the software's ability to function correctly on various computer platforms after being installed by the end-user, as stated after the risk analysis. The document lists the specific hardware configurations tested.

Acceptance Criteria (for the modification)	Reported Device Performance (for the modification)
Proper functioning of the software on specified computer platforms	"verification testing was performed to ensure proper functioning of the software on four computer platforms. Each of the four computer platforms tested meet the specifications of the LessRay® System as previously cleared." The specific platforms tested were: 1. ONYX 175z 2. Sony VAIO L Series 3. Maxant Mediport 3000 4. Dell Precision M6700

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

Test Set Sample Size: Four computer platforms were used for testing the software's functionality after installation.
Data Provenance: Not specified, but given it's functional testing of software installation, it's likely internal testing by the manufacturer.

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)

Not applicable for this modification. The testing described is functional verification of software on different hardware, not a clinical evaluation requiring expert ground truth.

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

Not applicable. This was functional testing, not a clinical evaluation.

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

Not applicable for this modification. This study pertains to a minor software distribution change, not a re-evaluation of the image enhancement algorithm's clinical effectiveness. The original 510(k) (K123226) would likely have addressed this type of study if relevant.

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

Not explicitly stated for K132970. The original submission (K123226) would have addressed the standalone performance of the image enhancement algorithm. The current submission focuses on the software's ability to run on various platforms after user installation.

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

Not applicable for the testing described in K132970, which is functional verification of software installation. For the image enhancement algorithm itself (from K123226), the document states the device "Improves quality of low does images" and "Displays reduced noise images", implying that subjective or objective measures of image quality (which would typically involve expert review or image quality metrics) were used as ground truth in the original clearance, but these details are not in K132970.

8. The sample size for the training set

Not mentioned in this document for the image enhancement algorithm, as this submission is for a modification, not the initial clearance of the algorithm. The software is described as using "data from prior images to improve quality of subsequent images" and "summation of prior full dose images with subsequent images", implying it is an adaptive/real-time processing rather than a 'trained' AI in the modern sense (e.g. deep learning requiring a large training dataset).

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

Not mentioned. As above, this information would pertain to the original clearance (K123226) of the image enhancement algorithm, not the current modification. The description of the algorithm (summation of prior full dose images) suggests a traditional image processing approach rather than a machine learning one that requires a "training set" with ground truth in the typical sense.

Summary

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K132970
Page 1 of 3

510(K) SUMMARY

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

Device Common Name:	Interventional Fluoroscope X-Ray System, Accessory
Device Proprietary Name:	LessRay®
Submitter:	SafeRay Spine, LLC5012 Chapel Hill Durham Blvd. Suite 203Durham, NC 27707
Contact:	Calley HerzogConsultant, Medical DevicesBiologics Consulting Group, Inc.Phone: 720-883-3633Fax: 720-293-0014Email: cherzog@bcg-usa.com	NOV 29 2013
Alternate Contact:	Donna-Bea Tillman, Ph.D.Biologics Consulting Group, Inc.Phone: 410-531-6542Email: dtillman@bcg-usa.com
Date Prepared:	September 19, 2013
Classification Regulation:	21 CFR 892.1650
Panel:	Radiology
Product Code:	OWB
Predicate Device:	K123226 - Submitter's own previously cleared device

Indication for Use:

The LessRay® 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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fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the monitor of the computer running LessRay®. Each image is displayed by LessRay at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).

Performance Data:

The subject of this 510(k) is a modification to the previously cleared LessRay® System. The l.essRay device that was previously cleared in K123226 was provided preloaded on a computer system. The only modification to the device since its previous clearance is that the software will now be provided on a CD for installation by the end user onto a computer that meets the stated specifications. These modifications represent a minor device modification and do not affect the indications for use. To assess the impact of this change a risk analysis was conducted. Based on the risk analysis verification testing was performed to ensure proper functioning of the software on four computer platforms. Each of the four computer platforms tested meet the specifications of the LessRay® System as previously cleared.

Substantial Equivalence:

The modification of the LessRay System to not provide it on a pre-loaded computer does not change the fundamental technology of the device or the intended use of the device. The algorithm used and the user experience are identical to that of the previously cleared version. Based on technological characteristics and indication for use, the modified device is substantially equivalent to the previously cleared LessRay" System.

	Proposed Device	Predicate Device
510(k) Number	K132970	K123226
Submitter	SafeRay Spine. LLC	SafeRay Spine. LLC
Classification Regulation	892.1650	892.1650
Product Code	OWB, LLZ	OWB, LLZ
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.
	Proposed Device	Predicate Device
Compatible HardwarePlatforms	1. ONYX 175zCPU: Intel Core 2 DuoGPU: NVIDIA Quadro 4000RAM: 8 GBHDD: 500 GBFrame Grabber: Aver MediaH339Windows 72. Sony VAIO L SeriesCPU: Intel Core i7GPU: NVIDIA GeForce 640MRAM: 8 GBHDD: 500 GBFrame Grabber: El GatoWindows 83. Maxant Mediport 3000CPU: Intel Core i7GPU: NVIDIA GTX660TIRAM: 8 GBHDD: 512 GBFrame Grabber: El GatoWindows 74. Dell Precision M6700CPU: Intel Core i5GPU: NVIDIA Quadro k3000MRAM: 8 GBHDD: 750 GBFrame Grabber: El GatoWindows 7	1. ONYX 175zCPU: Intel Core 2 DuoGPU: NVIDIA Quadro 4000RAM: 8 GBHDD: 500 GBFrame Grabber: Aver MediaH339Windows 7
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 doesimages	Yes	Yes
Uses data from prior images toimprove quality of subsequentimages	Yes	Yes
Algorithm used to improveimage quality	NO CHANGE from K123226	Summation of prior full doseimages with subsequent images

Table 1: Device Comparison Table

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K132970
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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Public Health Service

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

November 29, 2013

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

Re: K132970

Trade/Device Name: LessRay® Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: November 6, 2013 Received: November 7, 2013

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 (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.

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Page 2- Ms. Calley Herzog

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132970

Device Name LessRay(R)

Indications for Use (Describe)

The LessRay® 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Robert A Ochs

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.