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510(k) Data Aggregation
(20 days)
Optima XR240amx
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 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 is indicated for use on adult and pediatic 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 incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
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 an optional wireless RFID Reader and the associated software into the Optima XR240amx allows the user to gain access to the system using an RFID badge that has been assigned to them by the clinic or hospital that has employed them. This feature can be used in lieu of entering a physical User ID and Password into the Optima XR240amx user interface. In conjunction, the RFID reader will grant the user access to the drive control in lieu of entering a unique hardcoded pin on the Optima XR240amx user interface.
The system is 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.
This device is not intended for mammographic applications.
This 510(k) summary (device K182234) for the Optima XR240amx mobile X-ray system primarily addresses the incorporation of an optional wireless RFID reader and associated software. The submission aims to demonstrate substantial equivalence to its predicate device (Optima XR240amx with AutoGrid, K173602).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance for the primary function of X-ray imaging. Instead, it focuses on demonstrating that the modifications (incorporation of the RFID reader) do not negatively impact the existing safety and effectiveness of the device.
The "Determination of Substantial Equivalence" section lists compliance with various voluntary standards as a measure of meeting safety and performance requirements for the modified device:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | "The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." |
| IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for Safety 3. Collateral Standard: General Req. for Radiation Protection in Diagnostic XRay Equipment | "The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." |
| IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability | "The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." |
| IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | "The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." |
| IEC 62366 Medical devices - Application of usability engineering to medical Devices | "The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." |
| PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) set. (Radiology) | "The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." |
| AIM Standard 7351731 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers | "The modification to the Optima XR240amx to include a RFID Reader and its applications comply with voluntary standards" and "design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." |
| Risk Analysis and Mitigation Verification | "New risks were identified for incorporating the wireless RFID Reader and associated software into the Optima XR240amx. These risks were mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results." |
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, Optima XR240amx, did not require clinical studies to support substantial equivalence of incorporating an RFID Reader into the system to gain access to the system."
Therefore, there is no information provided about a "test set" in the context of clinical or imaging data, nor its sample size or provenance. The testing focused on engineering verification and validation of the RFID reader integration and its impact on the system.
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, as no clinical studies with a test set requiring expert ground truth were conducted for this specific submission. The assessment was primarily engineering-based.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies with a test set requiring adjudication were conducted for this specific 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 submission is for an X-ray system with an RFID reader, not an AI-assisted diagnostic device. Therefore, no MRMC comparative effectiveness study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for an X-ray system with an RFID reader, not a standalone algorithm. The RFID reader is a user authentication and access control mechanism, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies with a test set requiring ground truth were conducted for this specific submission. The ground truth for the engineering verification and validation would be adherence to specified design requirements, functionality, and safety standards, as verified through testing.
8. The sample size for the training set
Not applicable, as there is no mention of a training set. This submission is for hardware/software modification, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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(52 days)
Optima XR240amx, AutoGrid
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 incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
The Optima XR240amx with AutoGrid 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 with AutoGrid 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 with AutoGrid 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 AutoGrid software into the Helix Image Processing software on the Optima XR240amx allows the user to improve the image contrast in general radiographic images by reducing the effects of scatter radiation in lieu of incorporating a physical anti-scatter grid onto the cleared wireless detectors.
The system is 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.
This device is not intended for mammographic applications.
Here's an analysis of the acceptance criteria and the study conducted for the Optima XR240amx with AutoGrid, based on the provided text:
Device: Optima XR240amx with AutoGrid - an image processing software feature that can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images.
Goal of the Study: To demonstrate that AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a structured table format with corresponding reported performance metrics. Instead, it describes:
- Ability to achieve equivalent image contrast: The core performance goal is to demonstrate that AutoGrid can provide image contrast equivalent to physical anti-scatter grids.
- Scatter reduction: The software's mechanism is to estimate and subtract scatter radiation to improve image quality.
- Strength options: The software offers three strength options (Low, Medium, High) corresponding to physical 6:1, 8:1, and 12:1 ratio grids, respectively.
However, the document states the conclusion regarding device performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Achieve image contrast equivalent to a physical anti-scatter grid. | "Bench testing was sufficient to demonstrate that the AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid." |
| "The AutoGrid software that is incorporated into the Helix Image Processing software of the Optima XR240amx can be used in lieu of a physical anti-scatter grid... to improve image contrast in general radiographic images by reducing the effects of scatter radiation. This update to this system 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." | |
| "After analyzing design verification and validation testing on the bench it is the conclusion of GE Healthcare that the Optima XR240amx with AutoGrid to be as safe, as effective, and performance is substantially equivalent to the predicate devices." | |
| Operation with different scatter reduction strengths. | "The AutoGrid software can be configured at three global strength options (Low, Medium, and High). The strength indicates the amount of scatter reduction that will occur during image processing. The Low strength corresponds to the amount of scatter reduction that would occur through using a physical 6:1 ratio grid, Medium a physical 8:1 ratio grid, and High a physical 12:1 ratio grid." |
| Maintain safety and effectiveness. | "Safety testing (Verification)" and "Simulated use testing (Validation)" were performed. "New risks were identified... These risks were reviewed and mitigated... The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results." |
| "Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." | |
| Compliance with relevant standards (ES60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 62366, PS 3.1 - 3.20 DICOM set (Radiology)). | The modification and its applications "comply with voluntary standards" listing these standards. |
2. Sample Size for the Test Set and Data Provenance
The document states: "The subject of this premarket submission, Optima XR240amx with AutoGrid, did not require clinical studies to support substantial equivalence... Bench testing was sufficient to demonstrate that the AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid."
Therefore, there was no test set of patient data (images) in the traditional clinical sense. The testing was "bench testing," meaning it likely involved controlled experimental setups using phantoms or simulated data, rather than real patient images. The document does not specify the sample size of simulated images or controlled experiments used for this bench testing.
Data Provenance: N/A (as no clinical test set was used). The testing was "bench testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. Since the testing was bench testing and not a clinical study involving human readers or patient images, no experts were used to establish ground truth for a clinical test set.
4. Adjudication Method for the Test Set
N/A. As no clinical test set or human interpretation was involved, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence... Bench testing was sufficient..."
Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done in the form of "bench testing." This testing evaluated the AutoGrid software's ability to achieve image contrast equivalent to a physical anti-scatter grid without human interpretation as part of the primary evaluation. The results of this bench testing were considered sufficient to demonstrate performance.
7. Type of Ground Truth Used
The ground truth for the bench testing was established by physical standards or measurements related to image contrast and scatter radiation reduction, likely derived from the performance characteristics of physical anti-scatter grids (e.g., 6:1, 8:1, 12:1 ratios). The benchmark was the "equivalent" image contrast produced by these physical grids.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning, nor does it specify a sample size for such a set. AutoGrid is described as "image processing software" and its mechanism is to "estimat[e] the scatter radiation within the image, and then subtract[] this scatter estimate from the image." While this could imply some form of algorithm trained on data, the submission focuses on its performance validation through bench testing against existing physical grid benchmarks, rather than detailing an AI/ML training process.
9. How the Ground Truth for the Training Set Was Established
N/A. As no training set is explicitly mentioned or detailed, there is no information on how its ground truth might have been established.
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(19 days)
Optima XR240amx
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."
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