(204 days)
The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx, Optima XR200amx, Optima XR220amx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR220amx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Brivo XR285amx, Optima XR200amx, Optima XR220amx are self-contained; battery operated mobile radiographic imaging systems designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).
The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.
The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
These devices are not intended for mammographic applications.
The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx, Optima XR200amx, Optima XR220amx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR220amx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Brivo XR285amx, Optima XR200amx, Optima XR220amx are self-contained; battery operated mobile radiographic imaging systems designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).
The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.
The flat panel detector provides increased functionality to enable images of patients of all sizes, and can produce comparable quality images with as little as half the dose of traditional computer radiography (CR), cassettes and other flat panel detectors with lower DQE. The digital detector is designed to withstand a distributed load of 352Lbs to accommodate certain larger patients.
The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
These devices are not intended for mammographic applications.
1. A table of acceptance criteria and the reported device performance
The provided document describes the Brivo XR285amx, Optima XR200amx, Optima XR220amx mobile X-ray systems. It outlines the safety and performance evaluations conducted, but it does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics in a readily extractable table format.
Instead, the document states:
- "The Brivo and Optima Systems are certified to comply with the X-ray requirements of 21 CFR, arreautic spafety requirements of IEC 60601-1 and associated collateral and particular standards." (Page 3)
- "A review of all bench and standards testing indicate that the new device provides no new safety concerns and is as safe an effective as the predicate devices." (Page 3)
- "The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety standards, as confirmed by a Nationally Recognized Test Laboratory." (Page 4)
- "GE Healthcare considers the Brivo XR285amx, Optima XR200amx, Optima XR220amx to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." (Page 4)
- "It does not result in any new potential safety risks, has the same technological characteristics, and performs as well or better then devices currently on the market." (Page 4)
These statements indicate that the acceptance criteria were based on compliance with relevant regulatory standards (21 CFR, IEC 60601-1) and demonstrating substantial equivalence in safety and effectiveness to predicate devices. The "reported device performance" is implicitly stated as meeting these standards and being comparable or superior to predicate devices.
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 explicitly states: "The subject of this premarket submission, [Brivo XR285amx, Optima XR200amx, Optima XR220amx], did not require clinical studies to support substantial equivalence." (Page 3)
Therefore, there is no test set of clinical images or patient data described in this submission. The evaluation was based on non-clinical tests, bench data, and compliance with standards.
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)
As no clinical studies or test sets with patient images were conducted (as stated in point 2), there was no ground truth established by experts for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical studies or test sets were conducted (as stated in point 2), there was no adjudication method used for a test set in this 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
No MRMC comparative effectiveness study was done. The submission explicitly states no clinical studies were required or performed. There is no mention of AI assistance in this document, which predates widespread clinical AI applications in radiology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This submission is for X-ray imaging systems, not image analysis algorithms. The device itself is the primary subject of evaluation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no clinical studies were performed, no clinical ground truth (expert consensus, pathology, outcomes data) was used. The "ground truth" for the device's performance was established through compliance with technical standards and bench testing, demonstrating that the device meets specified electrical, mechanical, and radiation safety parameters, and its performance is substantially equivalent to predicate devices.
8. The sample size for the training set
Not applicable. This submission is for an X-ray imaging system, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As per point 8, there was no training set.
§ 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.