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.

Device Description

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.

AI/ML Overview

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.

Summary

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June 26, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

Dornier MedTech America % John Hoffer VP Quality/Regulatory 1155 Roberts Blvd KENNESAW, GA 30144

Re: K233380

Trade/Device Name: Trident Mobile Fluoroscopy System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: JAA Dated: May 24, 2024 Received: May 24, 2024

Dear John Hoffer:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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510(k) Number (if known)

K233380

Device Name

Trident Mobile Fluoroscopy System

Indications for Use (Describe)

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, neurologic, vascular, cardiac, critical care and emergency room procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Dornier's Trident Mobile Fluoroscopy System

Submitter

Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144 Date Prepared: June 25, 2024 Contact Person: John Hoffer Phone: 770-514-6163

Name of Device: Trident Mobile Fluoroscopy System Common or Usual Name: Image Intensified Fluoroscopic X-ray System Classification Name: Image Intensified Fluoroscopic X-ray System Regulatory Class/ Regulation Number: Class II / 21 C.F.R. § 892.1650 Product Code: JAA

Predicate Device OEC 9900 Elite (K120613) Common or Usual Name: Image Intensified Fluoroscopic X-ray System Classification Name: Image Intensified Fluoroscopic X-ray System Regulatory Class/ Regulation Number: Class II / 21 C.F.R. § 892.1650 Product Code: JAA/OXO

Intended Use / Indications for Use

Device Description/ Technological Characteristics

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.

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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.

The following table compares the technological characteristics of the Trident Mobile Fluoroscopy System and the primary predicate device.

	Trident MobileFluoroscopy System	OEC 9900 Elite	Dornier Nautilus
	Subject Device	Primary PredicateK120613	Reference DeviceK220871
510(k) Number
Intended Use/Indications for Use	The Trident MobileFluoroscopy System isdesigned to providefluoroscopic and spot-film images of thepatient duringdiagnostic, surgicaland interventionalprocedures. Examplesof clinical applicationmay includecholangiography,endoscopy, urologic,orthopedic, neurologic,vascular, cardiac;critical care andemergency roomprocedures.	The OEC® 9900 EliteMobile FluoroscopySystem is designed toprovide fluoroscopicand spot-film images ofthe patient duringdiagnostic, surgicaland interventionalprocedures. Examplesof clinical applicationmay includecholangiography,endoscopy, urologic,orthopedic, neurologic,vascular, cardiac;critical care andemergency roomprocedures.	The Dornier Nautilus isan image intensified,fluoroscopic x-raysystem that is intendedfor use in a wide field ofapplications, includingall generalexaminations in urologyand gynecology, as wellas endoscopic andcontrast examinations,imaging withradiography and/orfluoroscopy on patientsin either the horizontalor vertical position.
X-Ray Generator/Monoblock
Input Power	115 / 230 V	120V,200V,220V,230V,240V	480VAC
Power Rating (kW)	20 kW	15kW	80kW
Maximum kVp	120 kVp	120 kVp	150kVp
Maximum Rating(mA@kVp)	200mA	Up to 75mA	1000mA
kVp Range,radiographic	40 – 120kVp	40 - 120kVp	40-150kVp
mA Range,radiographic	Up to 200mA	Up to 75mA	10-1000mA
mAs Range	Up to 100	Up to 300	0.4-1000
kVp Range,Fluorographic	40 – 120kVp	40 - 120kVp	40-125kVp
mA Range,Fluorographic	Pulsed Fluoroscopy -up to 8mA (normal).HCF - up to 30mA	Pulsed Fluoroscopy0.2 – 10mA normal1.0 – 20mA HCF	PulsedFluoroscopy/HCF16-80mA,
FluoroscopyCapture Rate(frames/second)	With 2121 FPD – 0.5,1, 2, 3, 4, 5, 6, 7.5,12.5, 15With 3030 FPD – 0.5,1, 2, 3, 4, 5, 6, 7.5, 8,12.5, 15, 25	1, 2, 4, 8	0.25-30
Digital Cine Mode	Yes	Yes	Yes
Digital Cine(frames/second)	With 2121 FPD – 0.5,1, 2, 3, 4, 5, 6, 7.5,12.5, 15With 3030 FPD – 0.5,1, 2, 3, 4, 5, 6, 7.5, 8,12.5, 15, 25	Up to 30	Up to 30
X-ray Tube Housing
X-Ray Tube Type	Rotating anode	Rotating anode	Rotating anode
Focal Size	0,3 mm and 0,6 mm	0.3mm and 0.6mm	1.2mm;: 0.6mm
Heat Capacity	2106 kJ	1200kJ	3500kJ
SID	1041mm	1041mm	1100-1250mm
X-ray Tube Retraction	none	none	Motorized
Collimator	RALCOR650/027/QDASM	Tungsten Collimator	RALCO R650 DAMS
Imaging	Flat Panel Detector	12" Image Intensifier	Flat Panel Detector
Manufacturer	Varex	GE/OEC	Varex
Model / Type	PAX SCAN 3030 DXOR 2121DXV	Tri-mode 12"/9"/6"	PAX SCAN 4343DXV
Image receptor/x-ray detectionmaterial	AmorphousSilicone/Cesiumiodide		AmorphousSilicone/Cesium iodide
Maximum Active Area	3030 -298mm x298mm2121 – 209.9 x209.9mm		42.7 x 42.7cm
Pixel Size	3030 - 194 μm2121 - 205 μm		139 μm
Number of pixels(maximumdetector matrixsize)	3030 - 1536 x 15362121 - 1024 x 1024	1000k x 1000k CCD	3032 x 3032
Resolution	3030 –2.58 lp/mm @ 15 fps1.29 lp/mm @30 fps2121 –2.43 lp/mm @ 15 fps1.22 lp/mm @ 30 fps	12": 1.6 lp/mm9": 2.2 lp/mm6": 2.6 lp/mm	1.8 lp/mm @30fps3.6 lp/mm @15fps
Dose Indicator	Display of applieddose in μGy		Display of applied dose inμGy
Image Processing
Image Resolution	3030 - 1516 x 15162121 - 1004 x 1004	1000 x 1000	Up to 3072 x 3072
Image Processor	Technix	GE/OEC	Technix

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Air Kerma Display	Calculated by Imageprocessing SWCumulative air kerma rateis shown on the monitorsat the end of exposureDisplays real timeexposure rate		Calculated by Imageprocessing SWCumulative air kerma rateis shown on the monitorsat the end of exposureDisplays real timeexposure rate
ImageStorageCapacity	3030 - approx.110,000 images2121 - approx..250,000	1000	>110,000 images(depending on hard disksize and image file size)
Real-timeNoiseReduction	Yes	Yes	Yes
Real-timeEdgeEnhancement	Yes	Yes	Yes
Network ConnectivityDICOM 3.0	Yes	Yes	Yes

As demonstrated in the substantial equivalence table, the subject device, and reference devices have very similar technological characteristics. Any differences in technological characteristics are minor and do not raise new or different questions of safety or effectiveness. Performance data demonstrate that Dornier's Trident Mobile Fluoroscopy System is as safe and effective as the OEC 9900 Elite and Dornier Nautilus. Thus, the Trident Mobile Fluoroscopy System is substantially equivalent to the predicate and reference device.

Performance Data

The Trident Mobile Fluoroscopy System was tested in accordance to the FDA recognized consensus standards listed below:

These non-clinical tests were conducted on finished representative product and using the methods outlined in these standards. This performance testing confirmed that the Trident Mobile Fluoroscopy System contains all of the applicable requirements of the following standards:

Electrical Safety and EMC

IEC 60601-1:2005, AMD1:2012,Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 60601-1-6:2010+A1:2015, IEC 62366-2: 2007, A1:2014 Usability, .
IEC 60601-1-3:2008,A1:2013 1 Medical electrical equipment. Part 1: General ● requirements for safety; general requirements for radiation protection in diagnostic X-ray equipment
. IEC 60601-2-54:2009, A1 2015,A2 2019 Medical electrical equipment. Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-43:2010 Particular requirements for the basic safety and essential . performance of X-ray equipment for interventional procedures

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IEC 62304-2006/A1:2015 Software for Medical Devices Processes concerning software life cycle

Image Comparative Testing

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. Upon review by a certified radiologic they were found to be clinically acceptable based on a comparison to the predicate GE device.

Software Verification and Validation Testing:

The software has been documented for an Enhanced Documentation Level (Moderate Level of Concern) per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023.

Clinical testing is not necessary for the Trident Mobile Fluoroscopy System as the subject device contains the same fundamental technology as the predicate device, as well as detectors that have already been cleared. Successful bench and image testing results demonstrate substantial equivalence to the predicate device.

The results of the non-clinical performance standard testing further supports the safe and effective use of the Trident Mobile Fluoroscopy System.

Substantial Equivalence/Conclusions

The Trident Mobile Fluoroscopy System and the predicate device have the same indications for use and intended use, and similar technological characteristics and principles of operation. The minor technological differences between the Trident Mobile Fluoroscopy System and the predicate device do not present new or different questions of safety or effectiveness. Furthermore, performance testing has demonstrated that the subject device is as safe and effective as the predicate device. In addition, the subject and predicate device have similar principles of operation. Thus, the Trident Mobile Fluoroscopy System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.