(19 days)
The Optima XR240amx is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Optima XR240amx is a seff-contained; battery operated mobile radiographic imaging system 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 XR240amx is 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 system is 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.
This device is not intended for mammographic applications.
The Optima XR240amx is intended to take exposures, using a wired or remote exposure switch, utilizing film, computed radiography (CR), or cleared wireless radiographic detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Optima XR240amx is a self-contained; battery operated mobile radiographic imaging system 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 XR240amx system is 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 incorporation of cleared flat panel detectors 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 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 provided text describes the GE Healthcare Optima XR240amx mobile x-ray system and its substantial equivalence to predicate devices. It focuses on the changes introduced by incorporating cleared wireless detectors with WiFi communication.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic task for the Optima XR240amx itself, as the device is an imaging system rather than a diagnostic algorithm.
Instead, the acceptance criteria are implicitly related to demonstrating that the modifications (incorporation of WiFi-enabled detectors) do not negatively impact the safety and effectiveness of the device and that its performance is substantially equivalent to the predicate devices. The reported "performance" focuses on compliance with standards and successful verification and validation of changes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain Safety | Risk analysis, design controls, and labeling used to mitigate new risks from wireless image transfer. Mitigations verified and validated with acceptable results. |
| Maintain Effectiveness | Design verification and validation testing performed to confirm safety and effectiveness have not been affected. Test plans and results executed with acceptable results. |
| Substantial Equivalence to Predicate Devices | Uses same fundamental scientific technology (battery-operated mobile x-ray system). Same intended use and indications for use. Changes confined to wireless communication hardware (UWB to WiFi) and software/firmware to support new detectors. Performance "as good as," "as safe as," and "as effective as" predicate devices. |
| Compliance with Voluntary Standards | The device and its applications comply with voluntary standards. |
| Image Quality | The incorporation of cleared flat panel detectors 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." (This is a general performance characteristic of the detectors, not a specific criterion for the Optima XR240amx's modifications). |
2. Sample size used for the test set and the data provenance
The document states: "The subject of this premarket submission, Optima XR240amx, did not require clinical studies to support substantial equivalence for the incorporation WiFi (802.11) enabled detectors due to these detectors having their own 510(k) clearance."
Therefore, there isn't a "test set" in the traditional sense of a clinical trial with patient data. The testing mentioned in the document is primarily design verification and validation testing on the bench, not clinical data evaluation. The "data" provenance for these tests would be internal engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there was no clinical study with a patient test set requiring expert interpretation for ground truth establishment.
4. Adjudication method for the test set
Not applicable. No clinical test set.
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 device is a mobile x-ray system, not an AI or CAD (Computer-Aided Detection) device that assists human readers. Therefore, an MRMC study and analysis of AI assistance effect size are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. It is a hardware system for acquiring x-ray images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for clinical ground truth. The "ground truth" for the verification and validation tests would be defined by engineering specifications and expected system behavior, tested against established standards and successful operation.
8. The sample size for the training set
Not applicable. As this device is a hardware imaging system, there is no "training set" in the context of machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable. No training set for a machine learning algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the Optima XR240amx meets acceptance criteria primarily consisted of non-clinical design verification and validation testing.
- Rationale for non-clinical studies: The submission argued that clinical studies were not required because the changes were limited to wireless communication hardware and associated software to accommodate already cleared detectors (PerkinElmer, Inc. XRpad2 3025 HWC-M and XRpad2 4336 HWC-M Flat Panel Detectors, cleared under K161942 and K161966 respectively). The core imaging technology and intended use remained the same as the predicate devices (Optima XR200amx and Optima XR220amx, K142383).
- Verification and Validation Activities: GE Healthcare performed the following quality assurance measures:
- Risk Analysis (new risks from wireless image transfer were identified, mitigated with design controls and labeling, and verified/validated).
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
- Conclusion: The results of these design verification and validation tests were deemed "acceptable," leading GE Healthcare to conclude that the Optima XR240amx is as safe, effective, and substantially equivalent in performance to the predicate devices. The device's update "does not result in any new potential safety risks, it has the same technological characteristics, and perform as well as the devices currently on the market."
§ 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.