TRON is a mobile X-Ray imaging system with fluoroscopy and tomography capability that is intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture (such as the head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot).

Device Description

The TRON is a mobile fluoroscopy and cone-beam CT x-ray system for point-of-care (POC) imaging. The TRON system consists of a high voltage x-ray generator, 360-degree rotational open-bore gantry, x-ray tube assembly, x-ray controller, detector panel, and x-ray controls containing a power distribution unit, onboard PC and operator PC (user interface).

AI/ML Overview

The provided text describes the regulatory clearance of Xoran Technologies LLC's TRON device, but it does not contain information about specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), or a study that evaluates such performance using a test set with ground truth established by experts.

The document focuses on demonstrating substantial equivalence to a predicate device (Medtronic O-arm™ 02 Imaging System) and a reference device (Xoran Technologies xCAT) based on technological characteristics and Indications for Use.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document states that "TRON meets all the evaluation criteria for Bench Testing, SW Validation, and Product Validation tests," but it does not specify what those criteria are or report quantitative performance metrics against them.

2. Sample Size Used for the Test Set and Data Provenance

Not provided. The document states "N/A - No clinical testing was conducted for the TRON" and discusses "Bench Testing, SW Validation, and Product Validation testing" but offers no details about sample sizes or data provenance for these internal tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable/Not provided. Since no clinical testing was conducted and no test set with ground truth established by experts is mentioned for performance evaluation, this information is not available.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No test set requiring adjudication is described.

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/Not provided. The TRON device is an X-Ray imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/Not provided. The TRON is a hardware imaging system; the document does not describe an "algorithm only" component with standalone performance being evaluated independently of the system's operation. Its performance is inherent to its image acquisition capabilities.

7. The Type of Ground Truth Used

Not applicable/Not provided. As no clinical or performance study evaluating diagnostic accuracy against a ground truth is described, this information is not available. The testing performed focused on safety, effectiveness, and conformance to user needs, likely through engineering and design verification/validation rather than clinical diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable/Not provided. The TRON is an X-ray imaging system, not a device relying on machine learning or AI models that require a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. Similar to point 8, this is not relevant for the type of device described.

In summary, the provided FDA clearance letter and its associated documents (510(k) summary) do not detail performance acceptance criteria in terms of diagnostic accuracy or a study proving such criteria are met through evaluation against a ground truth. The submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use, as is common for many 510(k) submissions for imaging devices.

Summary

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July 28, 2022

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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Xoran Technologies LLC % Mark McGarrow VP of Quality and Operations 5210 S. State Rd. Ann Arbor MI 48108

Re: K221230

Trade/Device Name: TRON Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO, JAK Dated: April 28, 2022 Received: April 29, 2022

Dear Mark Mcgarrow:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Laurel Burk, 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

Enclosure

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Indications for Use

510(k) Number (if known) K221230

Device Name

TRON

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Number: K221230

This 510(k) summary of the Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Date Prepared: April 22, 2022

Submitter:

Xoran Technologies LLC 5210 S. State Road Ann Arbor, MI 48108

Contact Person:

Mark McGarrow Vice President of Quality and Operations Phone: 734-418-5125 Email: mark.mcgarrow(@xorantech.com

Device Name and Classification:

Trade Name:	TRON
Classification Name:	Interventional Fluoroscopic X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.1650
Regulation Name:	Image-intensified fluoroscopic x-ray system
Device Class:	Class II
Product Code:	OWB
Secondary Product Codes:	OXO, JAK

Predicate Device:

Trade Name:	Medtronic O-arm™ 02 Imaging System
510(k) number:	K200074 cleared 04/24/2020
Manufacturer:	Medtronic, Inc.
Classification Name:	Interventional Fluoroscopic X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.1650
Regulation Name:	Image-intensified fluoroscopic x-ray system
Device Class:	Class II
Product Code:	OWB
Secondary Product Codes:	JAA, OXO

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Reference Device:
Trade Name:	xCAT; xCAT for Neuro
510(k) number:	K061834 cleared 08/07/2006
Manufacturer:	Xoran Technologies LLC
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Device Class:	Class II
Product Code:	JAK

Device Description:

Indications for Use:

Substantial Equivalence:

TRON is substantially equivalent to the Medtronic O-arm™ 02 Imaging System in Indications for Use, hardware and technology. TRON is also substantially equivalent to the Xoran Technologies xCAT in technology, including both hardware and software. See comparison Table 1 and Table 2 below

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	Predicate Device:O-arm 02 Imaging System	Subject Device:TRON	Discussion
Classification	Class II	Class II	Identical
Product Code	OWB	OWB	Identical
Indications forUse	The O-arm O2 ImagingSystem is a mobile x-raysystem designed for 2D and3D imaging for adult andpediatric patients weighing60lbs or greater and havingan abdominal thicknessgreater than 16cm and isintended to be used where aphysician benefits from 2Dand 3D information ofanatomic structures andobjects with high x-rayattenuation such as bonyanatomy and metallicobjects.The O-arm O2 ImagingSystem is compatible withcertain image guidedsurgery systems.	TRON is a mobile X-Ray imaging systemwith fluoroscopy andtomography capabilitythat is intended to beused for anatomy thatcan safely fit within thedevice gantry andpositioned within theimaging aperture (suchas the head, neck,chest, abdomen, andextremities: arm, wrist,hand, leg, knee, ankle,and foot).	Equivalent
Cone Beam CT	The O-arm O2 ImagingSystem is a mobile cone-beam x-ray system withisocentric motion options. Itallows 3D imagereconstruction using a 360-degree rotation of the x-raysource and detector withinclosed gantry.	The TRON is a mobilecone-beam x-raysystem with isocentricmotion options. Itallows 3D imagereconstruction using a360-degree rotation ofthe x-ray source anddetector.	Equivalent
DetectorTechnology	40 x 30 cm (RoHScompliant, Flat-PanelDetector using a CsIscintillation)	40 x 30 cm (RoHScompliant, Flat-PanelDetector using a CsIscintillation)	Identical
X-ray GeneratorTechnology	32 kW generator	1.050 kW generator	Equivalent infunctionality
	Predicate Device:O-arm 02 Imaging System	Subject Device:TRON	Discussion
Collimator	Includes collimatorassembly	Xoran designed beamlimiter board 15006	FunctionalEquivalent
2D Imaging	2D Fluoroscopic	2D Fluoroscopic	Identical
3D Imaging	20cm and 40cm FOV	22cm FOV	Equivalent
Annotation	Allows for adding arrowslines and text to 2D imagesAdditional annotationcapability to performangular measurements ontoa 2D images. Thesemeasurements includeclosed, open and Cobbangles. It also provides theability to place a right angleon the image	While using the MPRviewer: Allows foradding arrows lines andtext to 2D imagesAdditional annotationcapability to performangular measurementsonto a 2D images.These measurementsinclude closed, openand Cobb angles. Italso provides the abilityto place a right angleon the image	Equivalent
Image Transfer	Automatically transfersauto-registered navigationscans. Easy Image Transfer:Depending upon the clinicalapplication and workflowwithin the procedure, thiswill automatically transfernon-auto-registered (non-navigated) images to thenavigation system	Easy Image Transfer:Depending upon theclinical application andworkflow within theprocedure. Includingbeing able to manuallyor automaticallytransfer images tonavigation systems orPACs as needed.	Equivalent
3D Visualization(EnhancedDynamic Range)	3D visualization of CBCTimage on the MVS. Itallows the user to windowlevel the images as well asrender oblique viewsImproved visualization ofimages that contain objectsof high-x-ray attenuationsuch as metal implants onthe Mobile View Station.	3D visualization ofCBCT image on theworkstation. It allowsthe user to windowlevel the images as wellas render obliqueviews.	Equivalent
	Predicate Device:O-arm 02 Imaging System	Subject Device:TRON	Discussion
Cybersecurity	Industry standard protocolswith error detection for datatransmission and storage.Authentication that includesusernames and passcodesSoftware integrity check	Industry standardprotocols with errordetection for datatransmission andstorage. Authenticationthat includes usernamesand passcodesSoftware integrity check	Equivalent
Mobility	Moves fluidly in your OR;Inter-room mobility forconcurrent cases	Can be easily movedfrom room to room andpositioned for scanningby one person.	Equivalent

Table 1 – Predicate Comparison

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Image /page/8/Picture/0 description: The image contains the logo for Xoran Technologies. The logo features a stylized letter X in a light blue color, partially overlaid by a square. To the right of the X, the word "ORAN" is written in the same light blue color, with the word "TECHNOLOGIES" appearing in smaller font beneath it. A trademark symbol is present to the upper right of the word "ORAN".

510(k) Summary

Table 2 – Reference Device

	Reference Device:xCAT	Subject Device:TRON	Discussion
Classification	Class II	Class II	Identical
Product Codes	JAK	OWB, OXO, JAK	JAK is Identical
Indications forUse	The xCAT is intended tobe used for x-raycomputed tomographyimaging of anatomy thatsafely fits into the imaginggantry (such as the head,neck, wrist, ankle, hand,and foot).	TRON is a mobile X-Rayimaging system withfluoroscopy andtomography capabilitythat is intended to beused for anatomy that cansafely fit within thedevice gantry andpositioned within theimaging aperture (such asthe head, neck, chest,abdomen, andextremities: arm, wrist,hand, leg, knee, ankle,and foot).	Identical with theexception thatTRON can also dofluoroscopy.
DetectorTechnology	40 x 30 cm (RoHScompliant, Flat-PanelDetector using a CsIscintillation)	40 x 30 cm (RoHScompliant, Flat-PanelDetector using a CsIscintillation)	Identical
X-ray GeneratorTechnology	1.050 kw generator	1.050 kw generator	Identical
Collimator	Xoran designed beamlimiter board 15006	Xoran designed beamlimiter board 15006	Identical
2D Imaging	2D Radiography	2D Fluoroscopic	Identical with theexception thatTRON can also dofluoroscopy.
	Reference Device:xCAT	Subject Device:TRON	Discussion
3D Imaging	A series of 360 degprojection data iscollected and processedusing sophisticatedalgorithms to generate a3D volumetric data(reconstructed data),commonly referred to ascomputed tomography(CT).	A series of 360 degprojection data iscollected and processedusing sophisticatedalgorithms to generate a3D volumetric data(reconstructed data),commonly referred to ascomputed tomography(CT).	Identical
Annotation	While using the MPRviewer: Allows for addingarrows lines and text to2D images Additionalannotation capability toperform angularmeasurements onto a 2Dimages. Thesemeasurements includeclosed, open and Cobbangles. It also provides theability to place a rightangle on the image	While using the MPRviewer: Allows foradding arrows lines andtext to 2D imagesAdditional annotationcapability to performangular measurementsonto a 2D images. Thesemeasurements includeclosed, open and Cobbangles. It also providesthe ability to place a rightangle on the image	Identical
Image Transfer	Easy Image Transfer:Depending upon theclinical application andworkflow within theprocedure. Includingbeing able to manually orautomatically transferimages to navigationsystems or PACs asneeded.	Easy Image Transfer:Depending upon theclinical application andworkflow within theprocedure. Includingbeing able to manually orautomatically transferimages to navigationsystems or PACs asneeded.	Identical
3D Visualization(EnhancedDynamic Range)	3D visualization of CBCTimage on the workstation.It allows the user towindow level the imagesas well as render obliqueviews.	3D visualization ofCBCT image on theworkstation. It allows theuser to window level theimages as well as renderoblique views.	Identical
	Reference Device:xCAT	Subject Device:TRON	Discussion
Cybersecurity	Industry standardprotocols with errordetection for datatransmission and storage.Authentication thatincludes usernames andpasscodes Softwareintegrity check	Industry standardprotocols with errordetection for datatransmission and storage.Authentication thatincludes usernames andpasscodes Softwareintegrity check	Identical
Mobility	Can be easily moved fromroom to room andpositioned for scanning byone person.	Can be easily movedfrom room to room andpositioned for scanningby one person.	Identical

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Comparison of Technological Characteristics:

The substantial equivalence of TRON with the predicate and reference devices are presented in the chart above and have the following overall shared technological characteristics:

Mobile Imaging: Wheeled configuration for point-of-care (POC) x-ray imaging.

All three devices are meant to be rolled to the patient location to perform x-ray imaging techniques for immediate image viewing at the POC.

Image Acquisition: Cone-beam x-ray configuration with flat panel detector.

All three devices use equivalent/identical components for x-ray imaging.

Imaging Bore: Gantry configuration with 360deg rotation.

All three device are configured to enable alignment for full rotation of the x-ray source and detector panel around the patient targeted anatomy.

Patient Support/Positioning: Used with standard patient supports.

All three devices are meant to be used with x-ray imaging compatible patient support tables/surfaces typically found in the hospital operating room setting. All three devices use on-board lasers to guide patient positioning of the targeted anatomy.

The detailed properties of the subject device (TRON) presented in the comparison tables above (see Table 1 and Table 2), and described throughout this submission, do not differ significantly from the legally marketed predicate device with regards to fundamental scientific technology, nor do they reflect a significant change in the indications for use. The differences between the subject device and the legally marketed predicate device have been assessed using Risk Management. The results of these efforts demonstrate that the device is as safe and effective as

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the predicate device and does not raise different questions of safety and effectiveness than the predicate.

Performance Testing:

TRON has undergone Bench Testing, SW Validation, and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs, indications for use, as required by 21 CFR 820.30 Design controls - (f) Design Verification, and (g) Design Validation.

The device testing has followed the same process and it has been documented in the manner listed below:

o The test plan and test instructions were laid out in the Test Protocol and Test Cases documents, where information such as test configurations, test sample sizes, and test result evaluation criteria, is established.
The testing was performed, and the results were captured in the Test Results document. ●
The testing was performed on production equivalent units. Tests were performed by ● qualified Xoran personnel, familiar with the function and use of TRON, but not directly responsible for its design.
The evaluation of the results and of the overall test result was discussed in the Test 0 Report document
Identified hazards and risks were tested and successfully mitigated by traceable 0 requirements.

TRON meets all the evaluation criteria for Bench Testing, SW Validation, and Product Validation tests

Performance Testing - Animal

N/A - No animal testing was conducted for the TRON

Performance Testing - Clinical

N/A - No clinical testing was conducted for the TRON

Conformance with IEC Standards

TRON has been designed to comply with the following standards:

0 EN 60601-1:2005
EN 60601-1-2:2015
EN 60601-1-3:2008 ●

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IEC 60601-2-44:2009 .

Guidance Documents and Resources

TRON has been designed utilizing the following FDA Guidance Documents:

Medical X-Ray Imaging Devices Conformance with IEC Standards ●
o Pediatric Information for X-ray Imaging Device Premarket Notifications
Guidance for Submission of 510(k)s for Solids State X-ray Imaging Devices ●
Information to Support a claim of Electromagnetic Compatibility (EMC) of Electricallyo Powered Medical Devices
The Image Gently Alliance Link: http://www.imagegently.org ●
FDA Pediatric X-ray Imaging Link: https://www.fda.gov/radiation-emitting-. products/medical-imaging/pediatric-x-ray-imaging

Conclusion

The TRON is intended for the same indications for use as the Medtronic O-arm™ 02 Imaging System. It uses components similar to those in the Medtronic O-arm™ 02 Imaging System (e.g. x-ray tube, collimator, x-ray generator, operator console). It is Xoran Technologies, LLC's opinion that the TRON is substantially equivalent to the cleared predicate device, the Medtronic O-arm™ 02 Imaging System

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.