The Quantum / Canon CXDI Integration System provides diagnostic quality images to aid the physician with diagnosis. The System can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The System is not indicated for use in mammography.

Device Description

The Quantum / Canon CXDI Integration System consists of add-on software that will allow the use of the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Canon CXDI Series System, including models CXDI-40EG or CXDI-50G, as a fully integrated digital imaging system.

AI/ML Overview

The provided text describes the Quantum / Canon CXDI Integration System, an add-on software designed to integrate existing Quantum Q-Rad Radiographic Systems with Canon CXDI Series Systems to form a fully integrated digital imaging system.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Generation of "diagnostic quality images"	"Performance data demonstrated that the Quantum / Canon CXDI Integration System...met pre-determined acceptance criteria."
Safety and effectiveness	"The Quantum / Canon CXDI Integration System meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness"
Substantial equivalence to predicate devices	"Performance data demonstrated that the Quantum / Canon CXDI Integration System is substantially equivalent to the predicate devices" and "The System is substantially equivalent to the predicate devices."
Acceptable risks	"The risks associated with use of the new device were found acceptable when evaluated by standardized risk/hazard analysis techniques."
Biocompatibility (for patient-contacting materials)	"No biocompatibility testing was conducted...all patient-contacting materials...have been previously cleared for similar devices."

Note: The document states that the device "met pre-determined acceptance criteria" and "meets all the pre-determined acceptance criteria." It does not provide specific quantitative metrics or thresholds for these criteria. The primary "performance" articulated is substantial equivalence to the predicate devices and the ability to produce diagnostic quality images.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Performance testing was successfully completed on the system in accordance with predetermined protocols based on the system design inputs."

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

The provided text does not specify the number of experts used or their qualifications for establishing ground truth for any test set.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The provided text does not mention an MRMC comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The device is an integration system for digital radiography, not an AI-powered diagnostic tool in the sense of offering independent assessments. It focuses on the technical integration and "diagnostic quality images."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device itself is an "integration system" that enables existing hardware to function as a "fully integrated digital imaging system." It's not described as an algorithm performing diagnostic tasks standalone. The focus is on the system providing "diagnostic quality images to aid the physician with diagnosis," implying human interpretation. Therefore, a standalone performance study in the sense of an AI algorithm making diagnoses without a human is not applicable and not described.

7. The Type of Ground Truth Used

The provided text does not specify the type of ground truth used for any performance testing beyond stating that diagnostic quality images are produced. The context suggests that the "ground truth" would be the clinical acceptability of the x-ray images for diagnosis, likely evaluated by medical professionals, but this is not explicitly detailed.

8. The Sample Size for the Training Set

The provided text does not specify a training set size. As the device is primarily an integration system for existing hardware and software to produce digital images, the concept of a "training set" in the context of machine learning is not explicitly detailed or relevant based on the information provided. The "performance testing" seems to be related to the system's ability to operate correctly and produce images comparable to predicate devices.

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

Since a training set is not mentioned or implied by the nature of the device (an integration system), the method for establishing its ground truth is not applicable and not described in the provided text.

Summary

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Quantum Medical Imaging, LLC Quantum / Canon CXDI Integration System Traditional 510(k) Premarket Notification March 26, 2008

Section 5 - 510(k) Summary

General Information

Korogos

Owner's Name:	Quantum Medical Imaging, LLC	JUL 1 6 2008
Address:	2002-B Orville Drive NorthRonkonkoma, NY 11779-7661
Telephone Number:	(631) 567-5800
Fax Number:	(631) 567-5074
Contact Person:	Mark Camirand; Director Q.A./Compliance
Subject Device Name:	Quantum / Canon CXDI Integration System
Common/Usual Name:	Stationary Electrostatic X-Ray System
Product Codes:	LLZ; KPR; MQB
Regulation:	21 CFR 892.2050 / 21 CFR 892.1680 / 21 CFR 892.1650
Classification:	Class II
Predicate Device Names:	Quantum Q-Rad Radiographic System / Quantum DiRex System / CanonCXDI-40EG Digital Radiography System / Canon CXDI-50G DigitalRadiography System
Manufacturers:	Quantum Medical Imaging, LLC / Canon, Inc.
Premarket Notifications:	K011486 / K072010 / K050987 / K031447

Device Description

Intended Use

Performance Testing

Performance data demonstrated that the Quantum / Canon CXDI Integration System is substantially equivalent to the predicate devices and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by standardized risk/hazard analysis techniques. Performance testing was successfully completed on the system in accordance with predetermined protocols based on the system design inputs.

No biocompatibility testing was conducted in support of this 510(k); all patient-contacting materials used in the manufacture of the Quantum / Canon CXDI Integration System have been previously cleared for similar devices.

Conclusion

The Quantum / Canon CXDI Integration System meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the System is substantially equivalent to the predicate devices.

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Quantum Medical Imaging, LLC Quantum / Canon CXDI Integration System Traditional 510(k) Premarket Notification March 26, 2008

Section 4 - Indications for Use Statement

510(k) Number (if known):
K080905

Device Name:

Quantum / Canon CXDI Integration System

Indications for Use:

Prescription Use _ X (Per 21 CFR 801 Subpart D)

מועדות במילה במילה במיני במ

Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number	K080905

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Section 5 - 510(k) Summary

General Information

ﻳﻨﺘﻬﺎ ﺑ

Owner's Name:	Quantum Medical Imaging, LLC
Address:	2002-B Orville Drive NorthRonkonkoma, NY 11779-7661
Telephone Number:	(631) 567-5800
Fax Number:	(631) 567-5074
Contact Person:	Mark Camirand; Director Q.A./Compliance
Subject Device Name:	Quantum / Canon CXDI Integration System
Common/Usual Name:	Stationary Electrostatic X-Ray System
Product Codes:	LLZ; KPR; MQB
Regulation:	21 CFR 892.2050 / 21 CFR 892.1680 / 21 CFR 892.1650
Classification:	Class II
Predicate Device Names:	Quantum Q-Rad Radiographic System / Quantum DiRex System / CanonCXDI-40EG Digital Radiography System / Canon CXDI-50G DigitalRadiography System
Manufacturers:	Quantum Medical Imaging, LLC / Canon, Inc.
Premarket Notifications:	K011486 / K072010 / K050987 / K031447

Device Description

Intended Use

Performance Testing

Performance data demonstrated that the Quantum / Canon CXDI Integration System is substantially equivalent to the predicate devices and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by standardized risk hazard analysis techniques. Performance testing was successfully completed on the system in accordance with predetermined protocols based on the system design inputs.

Conclusion

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Image /page/3/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo includes a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The word "DEPARTMENT" is printed in bold, sans-serif font to the right of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2008

Ms. Pamela Papineau, RAC Consultent Quantum Medical Imaging, LLC 2002-B Orville Drive North RONKONKOMA NY 11779-7661

Re: K080905

Trade/Device Name: Quantum / Canon CXDI Integration System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 3, 2008

Received: June 4, 2008

Dear Mr. Papineau:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy Bragdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Quantum Medical Imaging, LLC Quantum / Canon CXDI Integration System

Section 4 - Indications for Use Statement

510(k) Number (if known):

Quantum / Canon CXDI Integration System Device Name:

Indications for Use:

Prescription Use __ X (Per 21 CFR 801 Subpart D)

та се двини

Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hoza m Whan

(Divisio Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).