(80 days)
The AMX-4 Plus Mobile X-ray System is indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinics.
The AMX-4 Plus Mobile X-ray System consists of an X-ray Generator and Control, X-ray Tube, Beam Limiting Device and a new option called the Dose Area Product meter.
This submission, K021016, is for the GE Medical Systems AMX-4 Plus Mobile X-Ray System. The device is a conventional mobile X-ray system, and the submission primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for an AI/CADe system.
Therefore, the requested information components (1-9) which are typically associated with AI/CADe performance studies are not directly applicable or available in the provided text.
Based on the provided text, here's what can be extracted regarding the comparison and compliance:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria or performance metrics in a table as would be expected for an AI/CADe device. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to a legally marketed predicate device and conformance to relevant industry standards and regulations.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (AMX-3, K802047) | The AMX-4 Plus Mobile X-ray System is substantially equivalent to the AMX-3 Mobile X-ray System, K802047. The AMX-4 Plus does not include any new indications for use, nor does use of this device result in any new potential hazards. |
| Conformance to 21CFR 1020.30 and 1020.31 | The AMX-4 Plus Mobile X-ray System will conform to applicable sections of 21CFR 1020.30 and 1020.31. |
| Conformance to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3 | The system will also conform to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a mobile X-ray system, not an AI/CADe device that undergoes clinical performance testing with a specific test set of images.
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. Ground truth establishment with experts is not mentioned for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not mentioned for this type of device submission.
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. This is not an AI/CADe device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The submission focuses on substantial equivalence of the hardware and its compliance with standards for image generation, not diagnostic accuracy based on ground truth.
8. The sample size for the training set
Not applicable. The concept of a "training set" is not relevant to this hardware device submission.
9. How the ground truth for the training set was established
Not applicable. The concept of "ground truth for a training set" is not relevant to this hardware device submission.
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, creating a strong contrast. The logo is a well-known symbol associated with the General Electric company.
JUN 1 7 2002
GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).
| Identification of Submitter: | Larry A. Kroger, Ph.D.Senior Regulatory Programs ManagerGE Medical SystemsTel. (414) 544-3894Summary prepared: 21 March, 2002 |
|---|---|
| Identification of Product: | AMX-4 Plus Mobile X-Ray System |
| Classification Name: | Mobile X-ray System |
| Manufacturer: | GE Medical Systems3000 N. Grandview Blvd.Waukesha, WI 53118 |
| Device Description: | The AMX-4 Plus Mobile X-ray System consists of an X-rayGenerator and Control, X-ray Tube, Beam Limiting Device and anew option called the Dose Area Product meter. |
| Indications for Use: | The AMX-4 Plus Mobile X-ray System is designed to performradiographic x-ray examinations. |
| Comparison with: | AMX-4 Plus Mobile X-ray System is substantially equivalent tothe AMX-3 Mobile X-ray System, K802047. |
| Conformance: | The AMX-4 Plus Mobile X-ray System will conform to applicablesections of 21CFR 1020.30 and 1020.31. The system will alsoconform to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3. |
| Conclusions: | In the opinion of GE Medical Systems, the AMX-4 Plus Mobile X-ray System is substantially equivalent to the previously marketedAMX-3 Mobile X-ray System, K802047. The AMX-4 Plus doesnot include any new indications for use, nor does use of thisdevice result in any new potential hazards. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2002
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414. W-709 MILWAUKEE WI 53201
Re: K021016
Trade/Device Name: AMX-4 Plus Mobile X-Ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: March 27, 2002 Received: March 29, 2002
Dear Dr. Kroger:
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 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); 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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This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Snogdon
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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STATEMENT OF INTENDED USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AMX-4 Plus Mobile X-ray System
Indications for Use
The AMX-4 Plus Mobile X-ray System is indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinics.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use
Vorint A. Sipeon
(Division Sign-Off)
Division of Reproductive, Ab and Radiological Devi 510(k) Number
§ 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.