(57 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The AMX4-50 is an AMX portable that has been upgraded to accommodate the Canon 50G digital imaging system. The AMX4 will operate in the same manner as before except that, instead of using film cassettes, it will be making digital images with the Canon sensor. The original AMX system is disassembled and reconstructed with new batteries, a DC to AC power supply for the Canon digital imaging system, and enclosure sheet metal to accommodate the modifications. An added control coordinates x-ray exposure and digital image acquisition. The AMX4-50 asses the Canon CXDI-50G and the AMX4-31 uses the Canon CXDI-31 portable detector.
The provided document K063262 describes the AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic Systems. This device is an upgrade of the GE AMX-4 Plus Mobile X-ray System incorporating Canon digital imaging systems (CXDI-50G or CXDI-31).
The core of the submission is to demonstrate substantial equivalence to predicate devices, namely the GE AMX-4 Plus Mobile X-ray System (K021016) and the Sedecal Mobile X-Ray Units with Digital Detector (K043002).
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
The acceptance criteria provided are through comparison to predicate devices, focusing on functional aspects and compliance with existing standards rather than quantifiable performance metrics typical for AI/CADe devices.
| Characteristic | Acceptance Criteria (from predicate devices) | Reported Device Performance (AMX4-50/AMX4-31) |
|---|---|---|
| Intended Use | Mobile diagnostic x-ray for adult and pediatric subjects, exposures of skull, spine, chest, abdomen, extremities. | SAME (Mobile diagnostic x-ray for adult and pediatric subjects, exposures of skull, spine, chest, abdomen, extremities) |
| Power Source | Batteries charged by AC line | SAME |
| Image Acquisition | X-ray film (for GE AMX-4) OR Canon Digital Panel CXDI-50G (for Sedecal) | Digital Panel CXDI-50G or CXDI-31 portable detector |
| User Interface | N/A (GE AMX-4) OR Software Driven Touch Panel LCD (Sedecal) | Software Driven Touch Panel LCD for Digital Panel, Generator controls are NOT modified (AMX4 will operate the same as before digitally) |
| Digital Resolution | N/A (GE AMX-4) OR 160 x 160 microns pixel pitch, ~6 million pixels, 4,096 gray scale contrast (Sedecal) | SAME (Combined device: 160 x 160 microns pixel pitch, ~6 million pixels, 4,096 gray scale contrast) OR 100 x 100 microns for AMX4-31 with 6.5 million pixels, 4,096 gray scale contrast |
| Available Panel Sizes | N/A (GE AMX-4) OR CXDI-50G 35 x 43 cm (Sedecal) | CXDI-50G 35 x 43 cm; CXDI-31 22.6 x 28.8cm |
| Performance Standard | Complies with 21 CFR Part 1020 | SAME |
| Electrical Safety | UL/IEC | SAME |
| Safety and Effectiveness | As safe and effective as existing predicate devices. | "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." However, it does not provide specific details on:
- The sample size of the test set for user testing.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the user testing data).
- Any details about the "bench testing" other than its conclusion.
Given the nature of the device as a new iteration of an existing mobile x-ray system incorporating a new digital detector, the "user testing" likely refers to validating the functionality and usability of the integrated system in a clinical-like setting, rather than a diagnostic performance study on a large patient dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number or qualifications of experts used to establish a ground truth for any diagnostic performance test set. This type of information would typically be expected for devices that provide diagnostic interpretations or aid in diagnosis. Since this device is a digital radiographic system, the "ground truth" would implicitly be the image quality and diagnostic utility as perceived by a qualified radiologist or clinician during the "user testing", but no explicit details are given about this evaluation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for a test set. This is consistent with the nature of the device, which is a hardware system for image acquisition, not a software algorithm that provides diagnostic output requiring adjudication of its findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. The device is a radiographic system, not an AI/CADe tool intended to assist human readers in interpretation. Therefore, an MRMC study to measure the effect size of human readers' improvement with AI assistance is not applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (algorithm-only) was not done. This device is a digital radiographic system, which is hardware for image acquisition. It does not contain a standalone algorithm for diagnostic interpretation that would require such a study.
7. The Type of Ground Truth Used
The document does not explicitly define a "ground truth" in the context of diagnostic accuracy, as it would for a diagnostic AI device. The testing conducted was for safety and effectiveness, likely focusing on:
- Technical performance: Image quality (resolution, contrast, etc.), dose output, system functionality, and integration.
- Compliance with standards: Electrical safety, radiation emission, and mechanical integrity.
- User feedback: Usability and operational equivalence to existing systems.
The "ground truth" for showing substantial equivalence appears to be that the integrated system functions as intended by acquiring diagnostic quality images and that its performance (e.g., digital resolution) is equivalent to or better than the predicate digital detector system.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a hardware device (a mobile digital x-ray system) and not an AI or machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" and establishing "ground truth for a training set" is not applicable to this device, as it is a hardware system.
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Image /page/0/Picture/1 description: The image shows the text "EXHIBIT 2 510(k) Summary" at the top. Below the text is a logo for "VIRTUAL IMAGING". The logo consists of a stylized letter V on the left and the words "VIRTUAL IMAGING" in block letters on the right. The text is centered and the logo is aligned with the text.
720 S. Powerline Road S Deerfield Beach, FL 33442 954-428-6191 (Office) 954-428-6195 (Fax) October 18, 2006 Contact: Chris Duca, COO DEC 26 2006
- Identification of the Device: Proprietary-Trade Name: AMX4-50 and AMX4-31 Mobile Digital Diaganatic Radiographic Systems (Also offered as an upgrade kit to owners of the GE AX-4 Plus Mobile X-Ray System: AMX4-550 Retrofit Kit) 、, Classification Names System, x-ray, mobile Product Code Product Code IZL Common/Usual Name: Mobile X-Ray System
-
- Equivalent legally marketed device: GE AMX-4 Plus Mobile X-ray System, K021016 and CANON CXDI-50G Digital Radiography, K031447. The remanufactured device COMBINES these two units with an integrated control. A similar unit in the market would be the Sedecal Mobile X-Ray Units with Digital Detector, K043002.
-
- Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the shull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
-
- Description of the Device: The AMX4-50 is an AMX portable that has been upgraded to accommodate the Canon 50G digital imaging system. The AMX4 will operate in the same manner as before except that, instead of using film cassettes, it will be making digital images with the Canon sensor. The original AMX system is disassembled and reconstructed with new batteries, a DC to AC power supply for the Canon digital imaging system, and enclosure sheet metal to accommodate the modifications. An added control coordinates x-ray exposure and digital image acquisition. The AMX4-50 asses the Canon CXDI-50G and the AMX4-31 uses the Canon CXDI-31 portable detector.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
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| Characteristic | GE AMX-4 PlusMobile X-raySystem, K021016 | Sedecal MobileRay Units withDigital Detector,K043002. | AMX4-50 andAMX4-31 MobileDigital DiagnosticRadiographicSystems andAMX4-50 RetrofitKit |
|---|---|---|---|
| Intended Use: | Mobile diagnosticx-ray | SAME | SAME |
| Power source | Batteries charged byAC line | SAME | SAME |
| Image acquisition | X-ray film | Canon Digital PanelCXDI-50G | Digital PanelCXDI-50G or theCXDI-31 portabledetector (K003689/K023750) |
| User Interface | Software DrivenTouch Panel LCD | Software DrivenTouch Panel LCD forDigital Panel,Generator controls areNOT modified | |
| Digital Resolution | N/A | 160 x 160 micronspixel pitch, withapproximately 6million pixels and4,096 gray scalecontrast | SAME (Combineddevice) or 100 x 100microns for AMX4-31 with 6.5 millionpixels. 4,096 grayscale contrast |
| Available panelsizes | N/A | CXDI-50G35 x 43 cm | CXDI-50G35 x 43 cmCXDI-3122.6 x 28.8cm |
| PerformanceStandard | Complies with 21CFR Part 1020 | SAME | SAME |
| Electrical safety | UL/IEC | SAME | SAME |
6. Substantial Equivalence Chart, "AMX4-50 and AMS
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Virtual Imaging that the AMX4-50 and AMX4-31 System is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUM." written around the top half of the circle. Inside the circle is a symbol that consists of three curved lines that appear to be stacked on top of each other. The seal is black and white and has a simple design.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Virtual Imaging, Inc. % Mr. Daniel Kamm Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
DEC 26 2006
Re: K063262
Trade/Device Name: AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic System (Also offered as an upgrade kit to owners of the GE AMX-4 Plus Mobile X-Ray
System: AMX4-50 Retrofit Kit)
Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: October 26, 2006 Received: October 31, 2006
Dear Mr. Kamm:
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 commence prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devoces that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Nossmatic Act (Act) that do not require approval of a premarket approval application (PMA), You may cossn. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affectively 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.
Image /page/2/Picture/12 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" at the bottom. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlvindustry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use
510(k) Number (if known): K063262
Device Name: AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic Systems (Also offered as an upgrade kit to owners of the GE AMX-4 Plus Mobile X-Ray System: AMX4-50 Retrofit Kit)
Indications For Use:
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Syzmm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.