(30 days)
The Optima XR200amx and 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).
Optima XR200amx and Optima XR220amx are self-contained; battery operated mobile radiographic imaging systems designed to generate diagnostic 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 Optima XR200amx and Optima XR220amx 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, 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 Optima XR200amx and Optima XR220amx are intended to take exposures, using a wired or remote exposure switch, 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).
Optima XR200amx and 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 Optima XR200amx and Optima XR220amx systems 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 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.
I am sorry, but the provided text does not contain the detailed information necessary to complete your request. The document is a 510(k) summary for the Optima XR200amx and Optima XR220amx mobile x-ray systems. It primarily focuses on demonstrating substantial equivalence to predicate devices and discusses general compliance with standards, risk analysis, and verification/validation testing for changes related to an optional wireless exposure switch.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Information on the number or qualifications of experts used for ground truth.
- Details on adjudication methods.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Information on standalone algorithm performance.
- The type of ground truth used (beyond implying general diagnostic image quality).
- Sample size for training sets.
- How ground truth for training sets was established.
The document states: "The subject of this premarket submission, Optima XR200amx and Optima XR220amx, did not require clinical studies to support substantial equivalence for the option of initiating x-ray exposures with the use of the remote exposure switch." This indicates that a study with acceptance criteria and detailed performance metrics as you requested was likely not performed or at least not included in this particular 510(k) summary because the focus was on demonstrating equivalence of a minor modification (the remote exposure switch).
§ 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.