(268 days)
The Trident Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The Trident Mobile Fluoroscopy System is a mobile Image Intensified Fluoroscopic X-ray unit with a flat panel image receptor system. The Trident Mobile Fluoroscopy System consists of the following components: an X- ray generator and tube housing and a flat panel detector. An X-ray cabinet contains system elements such as the X- ray generator, power electronics for the imaging chain. The system offers an optional monitor for viewing the captured images. The X-Ray Generator is located in the base of the C-Arm. High voltage is carried to the X-Ray tube across a set of cables and the X-Ray tube emits the X-Rays that are directed toward the control of the operator. The X-Rays pass through the patient and are captured by the flat panel image detector (FPD). The flat panels used in the Trident Mobile Fluoroscopy System are Varex models 3030DX or 2121DXV. This Varex series have been used in similar cleared devices (K192541, K220871). The Varex flat panel system used in the Trident uses Cesium lodide as the image scintillator which is identical to that used in the reference device (K220871). These flat panel models differ only in the dimensions of the image receptor. FPD images are processed and can be displayed on the optional image monitor located on the Workstation. The Physician or system operator can view the images as they are displayed on the attached monitor or they may also choose to store the images for later review via the connection to the hospital DICOM system. The C-Arm is designed to move into the required positions to allow for proper x-ray locations in relation to the patient for the procedure that is being performed. These procedures can be performed with or without a patient table. In order to accomplish this, the system is designed with the ability to rotate/swivel to obtain different appropriate viewing angles. The systems movement is manually adjusted with the exception of the z-axis. This is motorized with the controls on the C-arm. The release of x-ray is controlled using a footswitch and/or a hand controller.
Here's a breakdown of the acceptance criteria and study information for the Dornier MedTech America Trident Mobile Fluoroscopy System, based on the provided FDA 510(k) summary:
This device is an X-Ray system, and the provided document is a 510(k) summary for substantial equivalence. For such devices, "acceptance criteria" and "device performance" in the context of clinical studies (like sensitivity, specificity, etc.) are generally not directly applicable in the same way as they would be for an AI-powered diagnostic device. Instead, substantial equivalence is proven through non-clinical performance testing against recognized standards and comparative image quality assessments.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The FDA 510(k) summary for this type of device (an X-ray system) primarily relies on demonstrating compliance with recognized performance standards and comparative image quality rather than traditional clinical performance metrics like sensitivity/specificity. Therefore, "acceptance criteria" here refers to successful completion of non-clinical tests and "reported device performance" refers to the results of those tests.
| Acceptance Criteria (Compliance Goal) | Reported Device Performance (Achievement) |
|---|---|
| Electrical Safety and EMC | |
| IEC 60601-1:2005, AMD1:2012 (Basic safety and essential performance) | Confirmed applicable requirements met. |
| IEC 60601-1-2:2014 (EMC) | Confirmed applicable requirements met. |
| EN 60601-1-6:2010+A1:2015, IEC 62366-2:2007, A1:2014 (Usability) | Confirmed applicable requirements met. |
| IEC 60601-1-3:2008, A1:2013 (Radiation protection in diagnostic X-ray) | Confirmed applicable requirements met. |
| IEC 60601-2-54:2009, A1 2015, A2 2019 (X-ray for radiography/radioscopy) | Confirmed applicable requirements met. |
| IEC 60601-2-43:2010 (X-ray for interventional procedures) | Confirmed applicable requirements met. |
| Software Performance | |
| IEC 62304-2006/A1:2015 (Software life cycle) | Software documented for Enhanced Documentation Level (Moderate Level of Concern) and meets requirements. |
| Image Quality (Clinical Acceptability) | |
| Images found clinically acceptable based on comparison to predicate | Comparative images using a pelvic phantom and a Primus phantom were reviewed by a certified radiologist and found to be clinically acceptable in comparison to the predicate GE device. |
| Substantial Equivalence | Achieved. Performance data (non-clinical tests and image comparison) demonstrated that the Trident Mobile Fluoroscopy System is as safe and effective as the OEC 9900 Elite and Dornier Nautilus, sharing similar indications for use, intended use, technological characteristics, and principles of operation, without raising new or different questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "Comparative images using the Trident Mobile Fluoroscopy System and the GE predicate device were taken to reflect usage conditions of the device. The images taken used a pelvic phantom as well as a Primus phantom." This indicates that the "test set" consisted of images generated from at least two phantoms (a pelvic phantom and a Primus phantom), but the exact number of images or imaging sequences is not specified beyond "images."
- Data Provenance: The images were acquired from phantoms, not human patients. The country of origin of the phantoms or the location of the imaging is not specified, but it would have been conducted as part of the manufacturer's non-clinical testing. This is a prospectively generated dataset for testing the device's image quality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "Upon review by a certified radiologic they were found to be clinically acceptable..." This indicates that one certified radiologist reviewed the images.
- Qualifications of Experts: The expert was described as "a certified radiologist." Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: The document states that a single certified radiologist reviewed the images and found them to be clinically acceptable. This implies no formal adjudication process (like 2+1 or 3+1 consensus) as only one expert was involved in the assessment for clinical acceptability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The study described involves a single radiologist reviewing phantom images to assess clinical acceptability compared to a predicate device. This is not an MRMC study comparing human reader performance with and without AI assistance.
6. If a standalone (algorithm only without human-in-the-loop performance) was done
- Yes, in essence, standalone performance was assessed. The device itself generates images. The "image comparative testing" described focuses on the quality of the images produced by the device (Trident Mobile Fluoroscopy System) compared to a predicate device, as assessed by a radiologist. This is an assessment of the device's output and its intrinsic image quality, separate from its operation by a human user in a clinical workflow. The "algorithm" here refers to the imaging system's capabilities in producing a diagnostic image.
7. The Type of Ground Truth Used
- Expert Consensus/Opinion on Image Quality: The ground truth for the image quality assessment was based on the "clinical acceptability" determined by a certified radiologist, comparing the images from the subject device to those from the predicate GE device. Since these were phantom images, "pathology" or "outcomes data" are not relevant here.
8. The Sample Size for the Training Set
- Not Applicable: This device is an X-ray imaging system, not an AI/ML-powered diagnostic algorithm that requires a "training set" in the conventional sense. The "training set" concept is typically relevant for machine learning models that learn from data. The reference here is to standard engineering design and testing, where components and systems are tested against specifications, not trained on data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no "training set" for an AI/ML model for this traditional imaging device, the establishment of its ground truth is not applicable.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.