(27 days)
The AMX Navigate 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).
AMX Navigate 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 AMX Navigate 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 a traditional RAD room.
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.
The AMX Navigate 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 AMX Navigate 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).
AMX Navigate 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 AMX Navigate 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 collapsible column allows for improved workflow by delivering a less obstructed view when driving the system and includes a motion assist to reduce user efforts when driving the column vertically.
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 a breakdown of the acceptance criteria and study information for the AMX Navigate device, based on the provided FDA 510(k) summary:
The AMX Navigate is a mobile x-ray system. The 510(k) pertains to a modification: the incorporation of an optional collapsible column and an improved algorithm for previewing images and image processing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | No new potential safety risks introduced by the modifications. | Verified and validated through risk analysis and testing. Mitigations were verified and validated with acceptable results. |
| Effectiveness | The device remains as effective as the predicate device. | Design verification and validation testing confirmed that effectiveness has not been affected. Test plans and results executed with acceptable results. |
| Performance | The device performs as well as the predicate device. | Design verification and validation testing confirmed that performance is substantially equivalent. Test plans and results executed with acceptable results. |
| Technological Characteristics | The modified device maintains the same fundamental scientific technology as the predicate and exhibits similar characteristics. | The AMX Navigate employs the same fundamental scientific technology as the predicate device (battery-operated mobile x-ray system, captures exposures using film, CR plates, or wireless detector). The modification is specifically for a collapsible column and improved image processing algorithm, not a change in core x-ray technology. |
| Intended Use | The intended use remains the same as the predicate device. | The intended use is the same as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary explicitly states:
- "The subject of this premarket submission, AMX Navigate, did not require clinical studies to support substantial equivalence of incorporating an optional collapsible column."
Therefore, there is no information provided regarding a test set sample size or data provenance for clinical performance evaluation. The evaluation was based on non-clinical design verification and validation testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no clinical studies were deemed necessary, there is no information provided regarding experts establishing ground truth for a clinical test set. The evaluation relied on engineering and quality assurance measures.
4. Adjudication Method for the Test Set
Since no clinical studies were conducted, no adjudication method was described for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states that clinical studies were not required. Therefore, no MRMC comparative effectiveness study was done to assess human reader improvement with or without AI assistance. The "AutoGrid" feature is an image processing software component, not an AI assistance for human readers in the context of interpretation.
- Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as no such study was performed or reported.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The "AutoGrid" is an optional image processing software intended to improve image contrast. While it's an algorithm, the document does not describe a standalone performance study in the context of diagnostic accuracy without human interpretation. Its performance is assessed as a component of the overall image quality improvement, which is then presumably interpreted by a human. The focus of the submission is on the safety and effectiveness of the mechanical and software modifications to the mobile x-ray system itself, particularly the collapsible column.
7. The Type of Ground Truth Used
For the non-clinical design verification and validation, the "ground truth" would be established by:
- Engineering specifications and design requirements: For hardware components and their functionality (e.g., column collapse mechanism, travel range).
- Physics and image quality metrics: For evaluating the effects of the new image processing algorithm (AutoGrid) on contrast improvement and scatter reduction, likely through phantoms and objective measures.
- Risk analysis and mitigation effectiveness: Demonstrating that identified risks are controlled.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning. The "AutoGrid" is described as an image processing software rather than a deep learning AI model that would typically require a training set. If it is an AI model, the training set information is not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not available.
§ 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.