The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Device Description

Aurora-RT is a medical device for image-guided radiation therapy (IGRT) that combines magnetic resonance imaging (MRI) with radiotherapy technology. It combines a 6 MV medical linear accelerator (Linac) and 0.5 T cryogenless superconducting MRI system mounted in a rotating gantry frame. The MR imaging capability is utilized for positioning the patient at the start of radiation therapy in place of computed tomography (CT) imaging that is commonly used in radiation therapy. MR imaging offers superior soft tissue contrast compared to CT and does not utilize ionizing radiation as with CT images.

AI/ML Overview

This document is a 510(k) Premarket Notification from MagnetTx Oncology Solutions Ltd. for their Aurora-RT device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (ViewRay MRIdian Linac System). The document focuses on regulatory compliance and technical specifications rather than clinical study data for device performance against specific acceptance criteria.

Therefore, the provided text does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets them. Specifically, the prompt asks for a table of acceptance criteria and reported device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types. This information is typically found in a clinical study report or a more detailed performance evaluation section of a 510(k) submission, which is not present in this summary document.

The document does mention "Summary of Performance Testing" (Section 5.9), stating that:

"Comprehensive performance testing has shown that the few differences in technological characteristics between Aurora-RT and the predicate device do not affectiveness of Aurora-RT for its intended use."
"Design control procedures applied to the development of Aurora-RT, including verification and validation testing, are in compliance with 21 CFR 820 FDA Quality System Regulation, ISO 13485 Medical devices – Quality management systems – Requirements for requlatory purposes, and ISO 14971 Medical devices – Application of risk management to medical devices."
"The performed testing demonstrated conformance to design requirements and recognized consensus standards and ensured all identified risks and hazards were mitigated."
"Software verification testing was conducted and documented in accordance with the FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' for devices that pose a major level of concern."
"Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as applicable general and collateral safety and essential performance standards for medical devices."

However, these statements are high-level summaries of compliance with general medical device regulations and standards (IEC 60601 series, IEC 61217, IEC 62304, IEC 62366-1) rather than a detailed breakdown of specific performance acceptance criteria and results for the device's clinical claims (e.g., precision radiotherapy for lesions, tumors).

Based on the provided text, the following information can be inferred or explicitly stated, but much of the requested detail is missing:

A table of acceptance criteria and the reported device performance:
- No specific clinical acceptance criteria for "precision radiotherapy" are provided in the context of device performance data.
- The document primarily compares technological characteristics (Max Dose Rate, Static Dose Accuracy, MLC characteristics, Isocenter Accuracy, MRI Field Strength, Field Homogeneity, Geometric Accuracy, SNR) between the proposed device (Aurora-RT) and the predicate device (ViewRay MRIdian Linac System). These are design specifications and technical performance parameters, not necessarily clinical 'acceptance criteria' tied to patient outcomes or a specific clinical study evaluation described in the way the prompt asks.
- For example:
  - Static Dose Accuracy for Linac:
    - Acceptance Criteria/Target (Aurora-RT): 90% of the points evaluated in a treatment volume pass a gamma criteria of 3%/3mm.
    - Reported Performance: Implied to meet this target, as the document states "The performed testing demonstrated conformance to design requirements and recognized consensus standards."
    - (Predicate Device: 90% of points pass relative gamma 3%/3mm AND high dose, low gradient absolute point measurement within 5% of planned dose.)
  - Isocenter Accuracy:
    - Acceptance Criteria/Target (Aurora-RT): 1 mm diameter
    - Reported Performance: Implied to meet this target.
  - Geometric Accuracy (MRI):
    - Acceptance Criteria/Target (Aurora-RT): < 1.0 mm VRMS over 20 cm DSV
    - Reported Performance: Implied to meet this target.
Sample sizes used for the test set and the data provenance: Not mentioned. The testing described appears to be engineering/verification testing, not a clinical study with patient samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The document describes a comparison to a predicate device based on technological characteristics and compliance with safety standards, not a comparative effectiveness study involving human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned in a clinical context. The "software verification testing" mentioned is general for software functionality and safety, not a performance evaluation of a specific algorithm (like an AI algorithm) for a clinical task. The device described is a radiation therapy system, not an AI diagnostic tool.
The type of ground truth used: Not specified in the context of clinical performance. For the engineering performance parameters listed (e.g., dose accuracy, geometric accuracy), the "ground truth" would be established by physical measurements and phantom studies against known standards.
The sample size for the training set: Not applicable, as this document does not describe the development or testing of an AI algorithm in the way the prompt implies. It's a hardware medical device with integrated software.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device primarily through technical specifications and compliance with general medical device safety and quality standards, rather than presenting clinical study data with specific acceptance criteria and detailed performance results for user-facing outcomes.

Summary

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MagnetTx Oncology Solutions Ltd. % Mr. Michael Cook Lead Regulatory Engineer 9505 41 Avenue NW Edmonton, Alberta T6E 5X7 CANADA

Re: K213526

Trade/Device Name: Aurora-RT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: April 1, 2022 Received: April 4, 2022

Dear Mr. Cook:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-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.

Julie Sullivan, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy 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) K213526

Device Name Aurora-RT

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY 5

The following information is provided for Aurora-RT in accordance with 21 CFR 807.92.

Submitter	MagnetTx Oncology Solutions Ltd.9505 41 Avenue NWEdmonton, Alberta T6E 5X7 CanadaTelephone: 587-458-1162
Primary Contact	Michael CookLead Regulatory EngineerTelephone: 587-458-1162michael.cook@magnettx.com
Secondary Contact	Brad MurrayChief Technology OfficerTelephone: 780-886-6728brad.murray@magnettx.com
Date Summary Prepared	March 31, 2022

Submitter Information 5.1

Device Identification 5.2

Trade Name	Aurora-RT
Common Name	Medical Linear Accelerator with Magnetic Resonance Image Guidance
Classification Name	Accelerator, Linear, Medical; System, Nuclear Magnetic Resonance Imaging
Classification Panel	Radiology
Regulation	21 CFR 892.5050, 21 CFR 892.1000
Device Class	Class II
Product Code	IYE, LNH

Predicate Device 5.3

ViewRay MRIdian Linac System with 138-leaf Collimator (K170751)

5.4 Device Description

Page 5-2 of 5-7

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5.5 Intended Use

Indications for Use 5.6

5.7 Substantial Equivalence

The Aurora-RT is substantially equivalent to the predicate device, the ViewRay MRIdian Linac System with 138-leaf Collimator (K170751), based on the intended use, indications for use, technological comparison, and performance data.

Technological Characteristics 5.8

The Aurora-RT uses the same fundamental technology as that of the ViewRay MRIdian Linac System: they are both Linac-MR devices that combine a 6 MV Linac and MRI system. The Aurora-RT and ViewRay MRIdian Linac System both use the same 6 MV photon energy for treatment delivery and the MRI systems have substantially equivalent magnetic fields (0.5 T for Aurora-RT vs 0.345 T for ViewRay MRIdian Linac System). The Aurora-RT, like the ViewRay MRIdian Linac System, provides intensitymodulated radiotherapy (IMRT) and is intended to be used by radiation oncology professionals.

The main technological difference between the two devices is that Aurora-RT utilizes a rotating biplanar magnet, which puts the main magnetic field parallel to the radiation beam. The ViewRay MRIdian Linac System uses a stationary Helmholtz-type magnet where the magnetic field is perpendicular to the radiation beam.

The main technological characteristics of Aurora-RT are compared to the ViewRay MRIdian Linac System in the table below, with the technological characteristics organized by the two main functionalities of the devices: Linac and MRI.

Parameter	Proposed Device: Aurora-RT	Predicate Device: ViewRayMRIdian Linac System (K170751)
Linac
Radiation Source	6 MV Linear Accelerator	6 MV Linear Accelerator
Beam	6 MV Bremsstrahlung X-Raysproduced by Linear Accelerator	6 MV Bremsstrahlung X-Raysproduced by Linear Accelerator
Max Dose Rate	600 cGy/min at Dmax at 120 cmisocenter for a 10 x 10 cm² field	600 cGy/min at Dmax at 90 cmisocenter for a 10 x 10 cm² field
Parameter	Proposed Device: Aurora-RT	Predicate Device: ViewRayMRIdian Linac System (K170751)
Static Dose Accuracy	90% of the points evaluated in atreatment volume pass a gammacriteria of 3%/3mm.	90% of the points evaluated in atreatment volume pass a relativegamma criteria of 3%/3mm and ahigh dose, low gradient absolutepoint measurement is within 5% ofthe planned dose (per AAPM TG119 based on the recommendationsof Palta et al.).
Collimation	Multi-Leaf Collimator (MLC) and 2independent Y jaws	Multi-Leaf Collimator (MLC) in twobanks
Projected MLC LeafWidth	0.475 cm	0.83 cm
Number of MLC Leaves	120 (single bank)	138 (68 in upper bank, 70 in lowerbank)
MLC Material	Tungsten Alloy	Tungsten Alloy
Isocenter Distance	120 cm	90 cm
Isocenter Accuracy	1 mm diameter	1 mm diameter
Radiation HeadShielding	Lead and Steel Shielding	Lead, Tungsten Alloy, and SteelShielding
Dosimetry System	Redundant ion chambers anddosimetry circuits	Redundant ion chambers and dosemonitoring cards
Radiation Transmissionthrough the head	Less than 0.1% of the primary beam	Less than 0.1% of the primary beam
Method of IMRT	Sliding Window and Step and Shootdynamic MLC	MLC based cone-beam delivery
Gantry	Rotating Gantry with front and backbearings	Ring Gantry, collision with patientnot possible
Patient table degrees offreedom	3 translational	3 translational
Motion SynchronizedTreatment	Not applicable	Yes (Gating utilized)
Linac Configuration	Rotates in tandem with magnet(fixed with respect to magnet)	Rotates about stationary magnet
Parameter	Proposed Device: Aurora-RT	Predicate Device: ViewRayMRIdian Linac System (K170751)
Treatment PlanningSystem	Treatment planning with existingcleared TPS	Treatment Planning and DeliverySystem (K102915 ViewRay) MonteCarlo Dose Computation RadiationSource Model for Bremsstrahlung X-Rays
Dose Output Modeling	Dose output modeled with monitorunits	Dose output modeled with monitorunits
Dose Display	Display of Linac delivery parameters	Display of Linac delivery parameters
MRI
Integrated imaging	Magnetic Resonance ImagingSystem (for positioning only prior totreatment start)	Magnetic Resonance ImagingSystem (for planning, positioning,and gating)
MR Configuration	Rotating biplanar magnet (openmagnet design)	Stationary Helmholtz-type magnet
Magnetic field/LinacBeam alignment	Parallel	Perpendicular
Bore Diameter	600 mm x 1100 mm (600 mm pole-to-pole spacing) ellipse defined bypole plates and front bearing	700 mm circle
Diameter SphericalVolume (DSV)	400 mm	500 mm
MRI Frequency	20.6 MHz	14.7 MHz
Field Strength	0.5 T	0.345 T
Field of View	400 mm	500 mm
Field Homogeneity	< 38 ppm (VRMS) measured over400 mm DSV	< 25 ppm measured over 450 mmDSV
Field Stability Control	Active control	Persistent superconducting magnet
Field Stability	< 0.1 ppm/min under active powersupply control	< 0.1 ppm/hour
3D Imaging Volumes[cm]	RL x AP x HF	RL x AP x HF
	Min 10 x 10 x 4	Min 20 x 27 x 29
	Max 40 x 40 x 30	Max 54 x 48 x 54
3D Imaging Resolution[cm]	RL x AP x HF	RL x AP x HF
	Min 0.04 x 0.04 x 0.04	Min 0.075 x 0.075 x 0.15
	Max 0.16 x 0.16 x 0.27	Max 0.3 x 0.3 x 0.3
Parameter	Proposed Device: Aurora-RT	Predicate Device: ViewRayMRIdian Linac System (K170751)
Geometric Accuracy	< 1.0 mm VRMS over 20 cm DSV	2 mm over 35 cm FOV1 mm over 20 cm FOV
Signal to Noise Ratio	> 30	30
Imaging Dose pertreatment	None	None

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5.9 Summary of Performance Testing

Comprehensive performance testing has shown that the few differences in technological characteristics between Aurora-RT and the predicate device do not affectiveness of Aurora-RT for its intended use. Design control procedures applied to the development of Aurora-RT, including verification and validation testing, are in compliance with 21 CFR 820 FDA Quality System Regulation, ISO 13485 Medical devices – Quality management systems – Requirements for requlatory purposes, and ISO 14971 Medical devices – Application of risk management to medical devices.

The performed testing demonstrated conformance to design requirements and recognized consensus standards and ensured all identified risks and hazards were mitigated.

Software verification testing was conducted and documented in accordance with the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for devices that pose a major level of concern.

Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as applicable general and collateral safety and essential performance standards for medical devices. The Aurora-RT has been found to conform to the medical device safety standards presented in the table below.

Standard No.	Edition (Year)	Title
IEC 60601-1	3.1 (2012)	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2	4 (2014)	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6	3.1 (2013)	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability
IEC 60601-2-1	3.1 (2014)	Medical electrical equipment - Part 2-1: Particular requirementsfor the basic safety and essential performance of electronaccelerators in the range 1 MeV to 50 MeV

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Standard No.	Edition (Year)	Title
IEC 60601-2-33	3.2 (2015)	Medical electrical equipment - Part 2-33: Particular requirementsfor the basic safety and essential performance of magneticresonance equipment for medical diagnosis
IEC 61217	2 (2011)	Radiotherapy equipment - Coordinates, movements and scales
IEC 62304	1.1 (2015)	Medical device software - Software life cycle processes
IEC 62366-1	1 (2015)	Medical devices - Part 1: Application of usability engineering tomedical devices

5.10 Conclusion

Verification and validation testing demonstrated that the Aurora-RT met established standards and design requirements. The differences between the Aurora-RT and the predicate device do not raise any new concerns of safety or effectiveness and do not negatively impact the device's performance for its intended use. Therefore, the Aurora-RT is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.