(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.
§ 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.