(20 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 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.
§ 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.