The LessRay™ is a stand-alone computer display system 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 LessRay™ monitor. Each image is displayed on the LessRay™ monitor at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the LessRay™ device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary does not explicitly state quantitative acceptance criteria in the form of specific metrics (e.g., minimum SNR improvement, maximum noise reduction percentage) that the LessRay™ device needed to meet. Instead, the "Performance Data" section discusses "validation tests" designed to establish substantial equivalence to the predicate device.

The reported device performance is described more qualitatively in relation to these tests and the comparison with the predicate device.

Test/Characteristic	Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Validation Test 1:	Not explicitly stated as a quantitative criterion. Implied: Demonstrated image improvement under low dose/pulse conditions.	The LessRay™ system can merge sequential and non-sequential images of the same anatomy to enhance image quality. It uses an averaging algorithm to use full-dose images to enhance image quality. "Validation testing demonstrate that the LessRay™ provides accurate and clinically relevant images."
Validation Test 2: Blocked Anatomy	Not explicitly stated. Implied: Effective image processing despite blocked anatomy.	(Performance not detailed beyond its execution)
Validation Test 3: Parallax Test	Not explicitly stated. Implied: Accurate image handling despite parallax.	(Performance not detailed beyond its execution)
Validation Test 4: Pig Study	Not explicitly stated. Implied: Safe and effective in a simulated clinical setting.	(Performance not detailed beyond its execution)
Overall Equivalence	As safe and effective as the predicate device (3DFIS).	"Performance testing demonstrates that the LessRay™ is as safe and effective as the 3DFIS." (Based on identical indication, similar technological characteristics, and results of performance testing). Provides reduced noise images.
Electrical Safety and EMC Standards	Compliance with IEC 60601-1 and IEC 60601-1-2.	The LessRay™ system meets these standards.

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

The document mentions "Validation Test 4 Pig Study." This implies the test set involved animal data. However:

The sample size for the test set (e.g., number of pigs, number of images acquired) is not specified.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified beyond it being a "Pig Study."

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

There is no information provided regarding the number or qualifications of experts used to establish ground truth for any of the validation tests, including the Pig Study. The document primarily focuses on technical and comparative performance rather than human-in-the-loop evaluation for establishing ground truth.

4. Adjudication Method for the Test Set

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

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The validation tests appear to be primarily focused on the device's technical performance and comparison to a predicate, not on how it impacts human reader performance or an "AI assistance" scenario (as the device is image enhancement, not an AI diagnostic tool in the modern sense).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are predominantly standalone performance assessments of the LessRay™ device. The "Validation Test 1 Low Dose/Pulse Image Improvement," "Validation Test 2 Blocked Anatomy," "Validation Test 3 Parallax Test," and "Validation Test 4 Pig Study" appear to evaluate the algorithm's output directly, rather than its impact on a human reader's decision-making. The description states, "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 LessRay™ monitor." This workflow implies the device processes and displays enhanced images, and the validation tests would assess the quality of these enhanced images.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the validation tests.

For "Low Dose/Pulse Image Improvement," ground truth might involve comparing enhanced images to high-dose images or using objective image quality metrics.
For "Blocked Anatomy" and "Parallax Test," ground truth would likely involve successful visualization or elimination of artifacts under controlled conditions.
For the "Pig Study," while not explicitly stated, ground truth would likely refer to the actual anatomical structures or known pathological conditions within the pig model, potentially confirmed by other imaging modalities or direct observation, against which the fluoroscopic images were judged for clarity and diagnostic utility.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The LessRay™ device is described as using an "averaging algorithm" to enhance images, which implies a rule-based or signal-processing approach rather than a machine learning model that typically requires a large training set.

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

Since there is no mention of a training set, there is no information provided on how ground truth for a training set would have been established.

Summary

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K128226

5.0 510(k) Summary be

DEC 05 2012

Device Common Name:	Interventional Fluoroscopic X-Ray System, Accessory
Device Proprietary Name:	LessRay™
Submitter:	SafeRay Spine, LLC 5103 Brookstone Dr. Durham, NC 27713
Contact:	Calley Herzog, Consultant to SafeRay Spine Biologics Consulting Group, Inc. Phone: 720-883-3633 Fax: 720-293-0014 Email: cherzog@bcg-usa.com
Date Prepared:	November 30, 2012
Classification Regulation:	892.1650
Panel:	Radiology
Product Codes:	Primary: OWB - Interventional Fluoroscopic X-Ray System, AccessoryAdditional Product Code: LLZ - System, Image Processing, Radiological
Predicate Device:	K013841 3D Sharp Fluoroscope Image System (3DFIS – Model IES-FL-101)
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:

. :

The LessRay™ is a stand-alone computer display system 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 LessRay™ monitor. Each image is displayed on the LessRay™ monitor at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).

: :

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・ ::.:.:

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Performance Data:

To establish the substantial equivalence of the LessRay™ device the following performance tests were performed: .::.:..

Validation Test 1 Low Dose/Pulse Image Improvement
Validation Test 2 Blocked Anatomy
Validation Test 3 Parallax Test
Validation Test 4 Pig Study

The LessRay™ system meets the following Electrical Safety and EMC standards:

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988
IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests

Substantial Equivalence Discussion:

The LessRay™ System is substantially equivalent to the 3DSharp Fluoroscope Image System (3DFIS) K013841. The 3DFIS is also designed to capture multiple images, manipulate the images arithmetically, and display the generated reduced noise images.

The differences between the LessRay™ System and the 3DFIS are that the LessRay™ System, the LessRay™ System can merge sequential and non-sequential images of the same anatomy to enhance image quality, while the 3DFIS merges only sequential images to enhance image quality. An additional difference is that the 3DFIS uses an algorithm similar to a Fourier transform to enhance image quality, while the LessRayTM System uses an averaging algorithm to use full-dose images to enhance image quality. Although the LessRay™ and 3DFIS use different mathematical methods to improve image quality, the results of validation testing demonstrate that the LessRay™ provides accurate and clinically relevant images. Therefore performance testing demonstrates that the LessRay™ is as safe and effective as the 3DFIS.

Substantial Equivalence Conclusion:

Based on the identical indication, similar technological characteristics, and results of performance testing, the LessRay™ is substantially equivalent to the 3D Sharp Fluoroscope Image System (3DFIS - Model IES-FL-101) as it was cleared in K0138413DFIS as it was cleared in K013841.

Device Characteristic	Predicate Device	Subject Device
510(k) Number	K013841	-
Device Name	3DFIS, MODEL IES-FL-101	LessRay™
Manufacturer	3DSHARP, INC.	SafeRay Spine, LLC
Computer	Dual G4 Power Mac	Intel Core 2 Duo Processor,8GB
Frame Grabber	Scion Corp, Model CG7	Hybrid ATSC/QAM/Analog F2Type Minicard w/10-pin AV-Input
Monitor	Apple 15" Flat Screen	17" LCD Touch Screen
Device Characteristic	Predicate Device	Subject Device
Operation System	MacOS 9.1	Windows 7
Image Processing Speed	30 frame/sec	10.6 frame/sec
Delay between frame acquisition	33msec	33msec
Indication	Indicated for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.	Indicated for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Stand-alone computer and monitor	Yes	Yes
Displays unaltered image from fluoroscope	Yes	Yes
Displays reduced noise images	Yes	Yes
For use during procedures that involve fluoroscopy	Yes	Yes

A detailed comparison is provided in the Table below:

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 5. 2012

SafeRay Spine, LLC % Ms. Calley Herzog Consultant Biologics Consulting Group, Inc. 13417 Quivas St. WESTMINSTER CO 80234

Re: K123226

Trade/Device Name: LessRayTM Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and LLZ Dated: October 15, 2012 Received: October 24, 2012

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 vour 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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Page 2-Ms. Herzog

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

Michael D. O'Hara

Janine M. Morris, M.S. 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 Statement 4.0

510(k) Number (if known):

Device Name: LessRay™

Indications For Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

Michael D. O'Hara

(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K 123226

Page 1 of __1

Page 13

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.