The Marie Imaging System is indicated for the acquisition of CT images and the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

Device Description

The Marie System is intended to acquire CT images and enable the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

The Marie System is intended to be used by healthcare professionals to image patients in an upright position rather than conventional supine treatments, to enable precise treatment planning and patient positioning for radiotherapy.

Specifically, it is intended to:

Image the patient to provide image-guided radiation therapy
Image the patient to acquire images for the purpose of treatment planning
Immobilize patients in an upright position for upright radiotherapy.

The Marie System is comprised of two major sub-systems: a computed tomography (CT) imaging system that performs pretreatment imaging and treatment simulation in the upright positions and a beam agnostic, patient positioning system that supports the patient in the upright positions.

The Marie Imaging System is used with compatible devices for treatment delivery and patient immobilization. The positioning system is designed with six degrees of freedom of motion and a patient positioning system to provide the desired posture for each cancer site to achieve accurate, reproducible patient setups, while the imaging system acquires helical scans by translating and rotating up the patient.

AI/ML Overview

The provided text solely describes the Leo Cancer Care Marie System as a Computed Tomography X-ray System with its features, safety, and performance details. It outlines the regulatory clearance (FDA 510(k)) based on substantial equivalence to a predicate device (P-ARTIS K160611). It describes the device's characteristics and the non-clinical tests performed to demonstrate its performance and functionality against design and risk management requirements.

Crucially, the provided text does not contain any information about acceptance criteria for AI performance, clinical study design, sample sizes for test or training sets, ground truth establishment using experts, or any MRMC comparative effectiveness studies. The document is a 510(k) clearance summary for a medical device (a CT imaging and patient positioning system), not for an AI diagnostic or assistive software. The "performance testing" section refers to hardware and software system performance, not AI model performance.

Therefore, I cannot answer most of your questions based on the provided input. The questions you've asked are typically relevant for AI/ML-based medical devices or diagnostics that involve image interpretation and require rigorous validation against human expert performance. The Marie System, as described, is a physical imaging system for patient positioning and CT image acquisition, not an AI software.

If this were an AI device, the answers would need to be extracted from sections detailing clinical performance studies, AI model validation, or similar. Since those sections are absent, I am unable to provide the requested information.

Summary

FDA 510(k) Clearance Letter - Leo Cancer Care Marie System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 25, 2025

Leo Cancer Care
℅ Nickie Power
Head of Regulatory and Quality
7921 UW Health Court
MIDDLETON, WI 53562

Re: K250970
Trade/Device Name: Marie
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Dated: March 31, 2025
Received: June 30, 2025

Dear Nickie Power:

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.

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K250970 - Nickie Power Page 2

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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250970 - Nickie Power Page 3

assistance/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, 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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FORM FDA 3881 (6/20) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K250970

Device Name: Marie

Indications for Use (Describe):

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Traditional 510(k) SUMMARY

Leo Cancer Care Marie System

I. SUBMITTER

Leo Cancer Care Inc
7921 UW Health Court
Middleton WI 53562
USA

Contact: Nickie Power
Nickie.Power@leocancercare.com

Establishment Registration # 3017500061
510(k) Number: K250970
Date: 28 March 2025

II. DEVICE

Trade Name: Marie
Product Classification: Class II
Common Name: CT Imaging and Patient Positioning System (for use with external Beam Treatment delivery system)
Regulation Number: 21 CFR 892.1750
Regulation Description: Computed tomography x-ray system
Product Code: JAK

III. PREDICATE

Predicate device: P-ARTIS K160611
Regulation Number: 21 CFR 892.1750 (Computed Tomography X-ray System)
Product Code: JAK

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IV. INDICATIONS FOR USE

V. DEVICE DESCRIPTION

Specifically, it is intended to:

Image the patient to provide image-guided radiation therapy
Image the patient to acquire images for the purpose of treatment planning
Immobilize patients in an upright position for upright radiotherapy.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

Characteristic	Leo Cancer Care Marie system	P-Cure P-ARTIS System – K160611
Intended Use	The Marie Imaging System is indicated for the acquisition of CT images and the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.	The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The system is intended for scanning patients while seated
Indications for Use	The Marie Imaging System is indicated for the acquisition of CT images and the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.	The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The system is intended for scanning patients while seated
CT scanner	Acquire CT images of patients to facilitate delivery of external beam radiation	Acquire CT images of patients to facilitate delivery of external beam radiation
Image Acquisition	Axial and Multi-slice helical scanning, 2D/3D reconstruction	Axial and Multi-slice helical scanning, 2D/3D reconstruction
Imaging system central bore diameter	84 cm	85 cm
Image resolution at 120kV, 250mA	4.0 lp/cm @ 50% MTF7.9 lp/cm @ 10% MTF10.0 lp/cm @ 2% MTF	4.3 lp/cm @ 50% MTF8.0 lp/cm @ 10% MTF15.0 lp/cm @ 0% MTF
Image Slice Thickness	0.625, 1.0, 2.0, 4.0, 5.0 mm	2.0, 3.0, 4.0, 5.0, 8.0 mm
Field of View	62cm	60cm
Imaging Angle	0-15 degrees	20 degrees
Gantry Scan Plane	Up and down over patient	Up and down over patient

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Characteristic	Leo Cancer Care Marie system	P-Cure P-ARTIS System – K160611
Patient load (maximum)	150 kg	375 kg
Patient Positioning Motion axis	6 degrees of freedom	Same as predicate
Motion drives	Computer controlled, servo motor based multi axis motion system.	Robotic positioning system (Computer controlled, servo motor system)
Patient orientation	Chair based patient support	Patient table couch or other approved patient support device
Speed	X: 0 – 50mm/secY: 0 – 50mm/secZ: 0 – 25mm/secPitch & Roll: 2 degrees per sec360 rotation: 6 degrees per sec	0.1 m/s and 6 degrees per sec
Accuracy	X: ±0.3mmY: ±0.3mmZ: ±0.7mmIso-rotation: ±0.1deg.Pitch & Roll: ±0.5deg	+/-0.5mm and +/- 0.2 degrees
Rotation	Full 360-degree rotation	Full 360-degree rotation
Patient support range of pitch	The backrest has 15-degrees from vertical	Support table has +/- 15 degrees of pitch

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VII. SUMMARY OF PERFORMANCE TESTING (NON-CLINICAL)

Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes, and FDA guidance¹.

Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system and system levels. Leo Cancer Care utilised the test methods and performance criteria outlined in the table below to demonstrate performance to current guidance.

Source	Performance Requirements
AAPM REPORT NO. 233 - Performance Evaluation of Computed Tomography Systems	- HU Accuracy ○ Water: ± 7 HU ○ Acrylic: ± 10 HU ○ Polyethylene: ± 10 HU ○ Bones: ± 60 HU ○ Air: ± 17 HU- Image uniformity ± 15 HU- Geometric Efficiency >70%
Quality assurance for image-guided radiation therapy utilizing CT-based technologies: A report of the AAPM TG-179	- Image resolution Line pairs: ≥10 lp/cm
Quality assurance for computed-tomography simulators and the computed tomography-simulation process: Report of the AAPM Radiation Therapy Committee Task Group No. 66	- Contrast to Noise: ≥1.0- Spatial Integrity (in-plane): ± 1 mm over at least 100 mm

Software verification testing was conducted and documented in accordance with FDA guidance for "Enhanced Documentation", (Class C per IEC 62304).

Basic safety and essential performance have been satisfied through conformance with recognized consensus standards for medical devices listed below.

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Standard	Title
ISO 14971:2019 Third Edition 2019-12	Medical Devices – Application of risk management to medical devices
IEC 60601-1: Edition 3.2, 2020	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-68: Edition 1.0, 2014	Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators light ion beam therapy equipment and radionuclide beam therapy equipment
IEC 60601-2-44: Edition 3.2, 2016	Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
IEC 60601-1-2 Edition 4.1 (2020-09)	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 62304:2016	Software life-cycle processes
IEC 60601-1-6:2020 Edition 3.2	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ANSI AAMI IEC 62366-1:2020 Edition 1.1	Medical Devices – Part 1: Application of Usability Engineering to Medical Devices

VIII. SUBSTANTIAL EQUIVALENCE CONCLUSION

The Marie System is substantially equivalent to the predicate devices in terms of intended use and technological characteristics. The devices safety and performance have been addressed by non-clinical testing in conformance with pre-determined performance criteria, FDA guidance, and recognized consensus standards.

The differences between Marie System and the predicate device raise no new efficacy or safety concerns.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.