(15 days)
The AMX5 and AMX5D are 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 AMX5 is a power driven mobile unit including an X-ray generator, X-ray tube, and beam limiting device, along with control electronics for the drive mechanism, and embedded software. The AMX5D is the same as the AMX5 but is used in conjunction with a portable digital X-ray detector.
The provided 510(k) summary for the AMX5 and AMX5D Mobile X-ray Systems states that "Clinical Tests: None required." These devices are considered substantially equivalent to the predicate device (AMX4 Plus Mobile X-ray system, K021016) based on comparable technological characteristics, safety, and effectiveness. Therefore, the information requested regarding acceptance criteria and studies to prove meeting them, in the typical sense of a new technology demonstrating diagnostic performance, is not applicable in this case.
Instead, the submission focuses on demonstrating equivalence through:
- Safety Standards: The devices were "evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical device safety standards." Compliance was verified through independent evaluation with factory surveillance.
- Intended Use and Technology Comparison: The AMX5 and AMX5D have the "same intended uses; incorporate the same technology; and use similar design, construction, materials, and features as the legally marketed AMX 4 Plus Mobile X-ray system."
Since no clinical studies were deemed necessary, there is no information available within the provided text for the following:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- Multi reader multi case (MRMC) comparative effectiveness study
- Standalone (i.e. algorithm only without human-in-the-loop performance) study
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.