Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.

Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.

When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Device Description

Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT).

The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.

When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

In addition to the MRI sequences cleared with the predicate device, the subject device Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment:

Introduce 3D Vane
3D Vane XD is a free breathing acquisition method that can be used to compensate for respiratory motion and peristalsis in 3D/FFE and 3D/TFE body imaging.

Introduce CS-Sense - compressed images
Compressed SENSE is an acceleration technique that is less sensitive to noise allowing increased resolution and/or coverage without a scan time penalty.

Introduce Breath Hold (BH) .
Breath-hold is a technique where an image is acquired when a patient holds their breath in a defined phase of the breathing cycle.

AI/ML Overview

The Elekta Unity device mentioned in the document is a medical charged-particle radiation therapy system. However, the provided document does not contain information about specific acceptance criteria or a dedicated study proving device performance against such criteria for AI/ML components.

The document primarily focuses on demonstrating substantial equivalence of the overall device (Elekta Unity with new imaging options) to a predicate device (Elekta Unity K192482). It lists performance testing for the overall system based on design verification, risk management, software verification, and conformance to recognized consensus standards.

Here's a breakdown of why the requested information cannot be fully provided based on the given text, and what information is available:

Missing Information (Specific to AI/ML acceptance criteria and performance study):

No explicit acceptance criteria for an AI/ML component: The document introduces new imaging options (3D Vane XD, CS-Sense, Breath Hold) but does not frame these as AI/ML applications requiring specific performance metrics like sensitivity, specificity, or AUC against a ground truth. They are described as "additional imaging options" or "acceleration techniques."
No dedicated study proving AI/ML device performance: There is no study described that evaluates the performance of any AI/ML algorithm within the Elekta Unity against a defined ground truth, nor are there details about sample size, expert readers, or adjudication methods for such a study.
No MRMC comparative effectiveness study for AI assistance: The document does not describe any study where human readers' performance with and without AI assistance was compared.
No standalone algorithm-only performance study: No study detailing the performance of an algorithm without human involvement is mentioned.
No details on ground truth for AI/ML training or testing: Since no specific AI/ML component is detailed with its own performance study, there's no information about the ground truth used for training or testing such components.
No sample size for training sets of AI/ML components: This information is not present.

What is available regarding overall device testing and compliance:

The document states broader performance testing was conducted for the Elekta Unity system, but these are general engineering and safety tests rather than AI/ML specific performance evaluations.

Design verification and performance testing: Carried out in accordance with FDA's Quality System Regulation (21 CFR §820.30), ISO 13485, ISO 14971, and IEC 62304.
Software verification testing: Conducted and documented in accordance with FDA guidance for devices that pose a major level of concern (Class C per IEC 62304).
Basic safety and essential performance: Satisfied through conformance with device-specific recognized consensus standards (listed in a table).

However, none of this directly answers the AI/ML-specific questions in your prompt. The "new imaging options" are presented as new functionalities of the MR system rather than intelligent algorithms for interpretation or decision support.

Therefore, a table of acceptance criteria and reported device performance for an AI/ML component cannot be created from the provided text. The document focuses on demonstrating that the device as a whole with its new MR imaging sequences maintains safety and effectiveness comparable to its predicate, largely through non-clinical engineering and software testing and adherence to general medical device standards.

Summary

{0}------------------------------------------------

October 1, 2021

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 below.

Elekta Solutions AB % Ms. Melinda Smith Director, Regulatory Affairs & Quality - Americas Elekta, Inc. 400 Perimeter Center Ter. NE Suite 50 ATLANTA GA 30346

Re: K212114

Trade/Device Name: Elekta Unity Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: June 30, 2021 Received: July 7, 2021

Dear Ms. Melinda Smith:

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

{1}------------------------------------------------

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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212114

Device Name

Elekta Unity

Indications for Use (Describe)

Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional imaqes in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.

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:
Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
"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."
FORM FDA 3881 (6/20)	Page 1 of 1
	PSC Publishing Services (301) 443-67

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo consists of a circular graphic with three smaller circles inside, followed by the company name "Elekta" in a bold, sans-serif font. The logo is teal in color and is set against a white background.

TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92)

I.	SUBMITTER	Elekta Solutions ABKungstensgatan 18 Box 7593Stockholm, SE SE10393
	Contact:	Melinda Smith, MS, RAC, CBAMelinda.Smith@elekta.com
	Establishment Registration #:	3015232217
	510(k) Number:	K212114
	Date Prepared:	30 June 2021
II.	DEVICE
	Trade Name:	Elekta Unity
	Product Classification:	Class II
	Common Name:	Radiation charged-particle radiation system
	Regulation Number:	21 CFR § 892.5050
	Regulation Description:	Medical charged-particle radiation therapy system
	Product Code:	IYE, LNH

PREDICATE DEVICE lll.

Predicate Device: Elekta Unity (K192482) Reference Devices: Philips Ingenia (K193215) and Elekta EMLA (K192242)

DEVICE DESCRIPTION IV.

{4}------------------------------------------------

Introduce 3D Vane ●

3D Vane XD is a free breathing acquisition method that can be used to compensate for respiratory motion and peristalsis in 3D/FFE and 3D/TFE body imaging.

● Introduce CS-Sense - compressed images

Compressed SENSE is an acceleration technique that is less sensitive to noise allowing increased resolution and/or coverage without a scan time penalty.

Introduce Breath Hold (BH) .

Breath-hold is a technique where an image is acquired when a patient holds their breath in a defined phase of the breathing cycle.

V. INTENDED USE

Elekta Unity is intended for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body under MRI quidance as determined by a licensed medical practitioner in accordance with a defined treatment plan. The Indications for Use statement defines the disease or condition to be treated (or diagnosed for MR functions).

VI. INDICATIONS FOR USE

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

Elekta Unity is designed specifically to facilitate IGRT. Both, current and predicate device configurations use the same medical linear accelerator (linac) to deliver photon energies and dose rates for targeted external beam radiation therapy using established magnetic resonance imaging technology for image guidance. Both devices rely on the same split magnet design to create an area of reduced X-ray attenuation for the treatment beam. Both devices use the same specifically designed software systems for treatment planning and delivery.

The similarities and differences in key device characteristics and performance specifications of the current and predicate Elekta Unity device configuration are noted in the table below:

{5}------------------------------------------------

Technological Characteristics Comparison		Unity(Subject Device)	Unity(K192482)
Radiation Source / Beam	7MV Bremsstrahlung X- Rays produced byLinear Accelerator	✓	✓
Method of IMRT	MLC based cone-beam delivery	✓	✓
Collimation	Field shaping, Multi Leaf Collimator (MLC)	✓	✓
MLC material	Tungsten Alloy	✓	✓
Number of leaves	80 leaf pairs	✓	✓
Range of MLC collimatedbeam size @ isocenter	0.5 cm x 0.5 cm to 57.4 cm x 22 cm	✓	✓
Gantry	Ring Gantry, collision with patient not possible	✓	✓
Radiation Head Shielding	Lead, Tungsten Alloy, and Steel shielding	✓	✓
Source control mechanism	Dual channel dose monitoring system	✓	✓
Radiation Transmissionthrough head	0.2% of the primary beam	✓	✓
Isocenter distance	143.5 cm	✓	✓
Isocenter accuracy (Radius)	0.5mm	✓	✓
Max Dose Rate	Clinical use: 450 cG/min at isocentre at Dmaxfor a 10 cm x 10 cm field(500 MU/min @ isocentre measured at Dmax)	ü	✓
Static Dose Accuracy	>95% of points passing 3%/3mm in the highdose, low gradient region>95% passing 5mm/5% for low dose, highgradient points1% agreement for output factors	✓	✓
Motion synchronizedtreatment	No - Manual interrupt only	✓	✓
Patient table degrees offreedom	2 (vertical & longitudinal) - positionalcorrections are made using the onlineadaptive planning interface of the treatmentplanning system	✓	✓
Integrated imaging forplanning, positioning, gating	Magnetic resonance imaging system - forplanning, positioning and motion monitoringduring treatment	✓	✓
MR PhysicalCharacteristics	Bore Diameter: 700 mmDiameter Spherical Volume:500 mm x 500 mm x 450 mm	✓	✓
MRI FrequencyField StrengthField of ViewField HomogeneityField Stability	64 MHz1.5TUp to 500 mm Sequence dependent≤ 2 ppm measured over 50 cm x 50 cm x 45cm volume≤ 0.1 ppm/hour	✓	✓
3D Imaging Volumes (cm)3D Imaging Resolution (cm)	RL x AP x HFMin 0.5 x 0.5 x 0.8Max 56 x 56 x 40 (Anterior coil dependent)Min 0.01 x 0.01 x 0.1Max 0.875 x 0.875 x 1	✓	✓
Technological Characteristics Comparison		Unity(Subject Device)	Unity(K192482)
2D Imaging Planes (cm)	AP x HFMin 0.5 x 0.5Max 56 x 56	✓	✓
2D Imaging Resolution(mm)	Resolution selectable:0.011 x 0.011 mm (min)8.75 x 8.75 mm (max)Slice thickness selectable:0.01 mm (min); 705 mm (max)	✓	✓
Geometric Accuracy	<=1 mm over 20 cm FOV (Guaranteed)<=2 mm over 34 cm FOV (Guaranteed)<=2 mm over 42 cm FOV (Typical)
Signal to Noise	120
Diffusion Weighted Imaging(DWI)	Diffusion Weighted Images can be importedfrom an alternative magnetic resonanceimaging device for Off-line review.	✓	✓
Treatment Planning andDelivery System	GPU-based Monte Carlo dose calculationalgorithm (GPUMCD) using the compatibleElekta MONACO treatment planning system	✓	✓
Dose Output ModellingDose Display	Dose output modelled with monitor unitsDisplay of Linac delivery parameters
Compressed Sense(CS-SENSE) imagingoption	Additional imaging options for diagnosis,treatment planning, and position verification.	✓	×
Breath-Hold imaging option	Additional imaging options for diagnosis,treatment planning, and position verification.	✓	×
3D Vane XD imaging option	Additional imaging options for diagnosis,treatment planning, and position verification.	✓	×
Minimum RoomDimensions	(H/L/W) 3.25 m x 6.7 m x 6.7 m
Environment Line VoltageAmbient Room Temp.	480VTreatment room: 18 to 22 °C(65 °F to 72 °F)	✓	✓
Relative Humidity	Treatment room: 40 to 70%, non- condensingTransformer
Power Distribution Isolation

{6}------------------------------------------------

SUMMARY OF PERFORMACE TESTING (NON-CLINICAL) VIII.

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, integration and system levels. Software verification testing was conducted and documented in accordance with FDA guidance2 for devices that pose a major level of concern (Class C per IEC 62304).

1 Submission of Premarket Notifications for Magnetic Devices – Guidance for Industry and Food and Drug Administration Staff, November 2016

2 Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, May 2005

{7}------------------------------------------------

Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards, as well as the general and collateral safety and essential performance standards for medical devices listed below.

Standard No.	Standard Title
ISO 14971	Medical Devices - Application of risk management to medical devices
IEC 60601-1	Medical electrical equipment - Part 1: General requirements for basic safety andessential performance
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral Standard: Electromagnetic
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirements for basic safety andessential performance - Collateral standard: Usability
IEC 60601-2-1	Medical electrical equipment - Part 2-1: Particular requirements for the safety of electronaccelerators in the range of 1 MeV to 50 MeV
IEC 60601-2-33	Medical electrical equipment - Part 2-33: Particular requirements for the safety ofmagnetic resonance equipment for medical diagnosis
IEC 61217	Radiotherapy equipment - Coordinates, movements and scales
IEC 60976	Medical electrical equipment. Medical electron accelerators. Functional performancecharacteristics
IEC 62304	Medical device software - Software life-cycle processes
IEC 62366-1	Medical devices - Application of usability engineering to medical devices
ANSI IEEEC63.18	Recommended Practice for an On-Site, Ad Hoc Test Method for EstimatingElectromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF)Emissions from RF Transmitters
ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process

IX. SUMMARY OF PERFORMACE TESTING (CLINICAL)

No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that Elekta Unity is as safe and effective and performs as well as the predicate device Elekta Unity.

X. SUBSTANTIAL EQUIVALENCE CONCLUSION

Elekta Unity is substantially equivalent (SE) to the predicate device, Elekta Unity (K192482). The intended use and indications for use are identical to the predicate device and the principles of operation remain unchanged.

The technological characteristics are substantially equivalent to the predicate device; the differences in imaging functionality between the two devices do not affect the fundamental scientific technology or raise different questions of safety or effectiveness of the device. The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria, FDA quidance, and recognized consensus standards.

The results of verification and validation as well as conformance to relevant safety standards demonstrate that Elekta Unity meets the established safety and performance criteria and 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.