(15 days)
The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.
The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Agfa DX-S CR System (digitizer with NX workstation). The Quantum DiRex System is a combination of these previously cleared systems that have been combined and will be marketed as a single system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum DiRex System:
Based on the provided text, the Quantum DiRex System is an integrated digital imaging system that combines the Quantum Q-Rad Radiographic System with the Agfa DX-S CR System. The primary acceptance criteria for this submission revolve around demonstrating substantial equivalence to predicate devices and meeting pre-determined performance criteria.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Quantum DiRex System is substantially equivalent to the predicate devices and/or met pre-determined acceptance criteria." |
| Meet Pre-determined Performance Criteria | "Performance data demonstrated that the Quantum DiRex System... met pre-determined acceptance criteria." and "Performance testing was successfully completed on the proposed system in accordance with predetermined protocols based on the system design inputs." |
| Acceptable Risks | "The risks associated with use of the new device were found acceptable when evaluated by standardized risk/hazard analysis techniques." |
| Biocompatibility | "No biocompatibility testing was conducted... all patient-contacting materials... have been previously cleared for similar devices." (No new testing required as materials were pre-cleared) |
| Technological Characteristics Identity | "The technological characteristics are the same in the proposed and predicate devices." |
| Safety and Effectiveness Confirmation | "The Quantum DiRex System meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or data provenance. The descriptions are general statements about "performance data" and "performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention any expert review committee, experts used to establish ground truth, or their qualifications. The testing appears to be focused on technical performance and equivalence, rather than clinical efficacy studies requiring expert reader consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method.
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
No, an MRMC comparative effectiveness study was not conducted. This submission is for a digital X-ray system, not an AI-powered diagnostic device, hence, there is no mention of human readers improving with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a medical imaging system (hardware and associated software for image acquisition), not a standalone diagnostic algorithm. The performance described relates to the system's ability to produce diagnostic quality images, not an automated reading of those images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used. Given the nature of the device (an imaging system, not a diagnostic algorithm), the "performance testing" likely involved evaluating image quality metrics, dose, system functionality, and compliance with pre-determined technical specifications (e.g., spatial resolution, contrast resolution, noise, consistency) rather than clinical ground truth diagnoses.
8. The sample size for the training set
The document does not mention a training set sample size. This is expected as the device is an imaging system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is an imaging system and not an AI/ML model requiring a training set with established ground truth.
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AUG - 7 2007
Section 5 - 510(k) Summary
General Information
| Owner's Name: | Quantum Medical Imaging, LLC |
|---|---|
| Address: | 2002-B Orville Drive North |
| Ronkonkoma, 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 DiRex 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 / Agfa DX-S CR System / Agfa DX- |
| Si System / Agfa CR85-X Digitizer / Agfa CR30-X | |
| Manufacturers: | Quantum Medical Imaging, LLC / Agfa Corp. |
| Premarket Notifications: | K011486 / K053634 / K063421 / K062742 / K062223 |
Device Description
The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Agfa DX-S CR System (digitizer with NX workstation). The Quantum DiRex System is a combination of these previously cleared systems that have been combined and will be marketed as a single system.
Intended Use
The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts.
Performance Testing
Performance data demonstrated that the Quantum DiRex 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 proposed 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 DiRex System have been previously cleared for similar devices.
Technological Characteristics
The technological characteristics are the same in the proposed and predicate devices.
Conclusion
The Quantum DiRex System meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the DiRex System is substanially equivalent to the predicate devices.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of human figures. The text is in a blue font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Quantum Medical Imaging, LLC % Mr. Jeff Rongero Senior Project Engineer, Medical Business Unit Underwriters Laboratories, Inc. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709
Re: K072010
Trade/Device Name: Quantum DiRex System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: July 17, 2007 Received: July 23, 2007
AUG 2 1 2013
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of August 7, 2007.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 nredicate 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 Parts 801 and 11 you don't open and the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 To a may 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement
510(k) Number (if known):
Device Name:
Quantum DiRex System
Indications for Use:
The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
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)
Herbert Werner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices KORZOLO 510(k) Number
10
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.