The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton treatment plans and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

contouring
image manipulation
simulation
image fusion
plan optimization
QA and plan review

Device Description

The Monaco RTP System accepts patient diagnostic imaging data from CT and MR scans, and source dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation, on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. Monaco RTP system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The optimal plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.

The parameters of the plan are output for later reference and for inclusion in the patient file. Monaco planning methods and modalities:

Intensity Modulated Radiation Treatment (IMRT) planning
Electron, photon and proton treatment planning
Planning for dynamic delivery methods (e.g. dMLC, dynamic conformal, Volumetric Modulated Arc Therapy (VMAT))
Stereotactic planning and support of cone-based stereotactic
3D conformal planning
Adaptive planning (e.g. for the Elekta Unity MR-Linac)
Monaco basic systems tools, characteristics, and functions:
Plan review tools
Manual and automated contouring tools
DICOM connectivity
Windows operating system
Simulation
Support for a variety of beam modifiers (e.g. MLCs, blocks, etc.)
Standardized uptake value (SUV)
Specialty Image Creation (MIP, MinIP, and Avg)
Monaco dose and Monitor Unit (MU) calculation:
Dose calculation algorithms for electron, photon, proton planning

Monaco is programmed using C and C++ computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.

AI/ML Overview

The provided text is a 510(k) summary for the Monaco RTP System, an updated version of a previously cleared device. It largely focuses on demonstrating substantial equivalence to the predicate device and does not contain detailed acceptance criteria or a study proving the device meets them in the format requested. The document explicitly states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a clinical study.

However, based on the non-clinical performance testing described, here's what information can be extracted:

1. A table of acceptance criteria and the reported device performance:

Based on the provided text, specific numerical acceptance criteria and corresponding reported device performance values are not available. The document states that "Design verification and performance testing were carried out in accordance with design controls... against design and risk management requirements at sub-system, integration and system levels." It also mentions "Software verification testing was conducted and documented in accordance with FDA quidance 1 for devices that pose a major level of concern (Class C per IEC 62304)." However, the actual criteria for these verifications (e.g., specific error margins for dose calculation, response times for image manipulation) and the measured performance against those criteria are not detailed.

2. Sample size used for the test set and the data provenance:

Sample size used for the test set: Not specified. The document mentions "sub-system, integration and system levels" testing, but no specific number of test cases or data sets are provided.
Data provenance: Not specified. As no clinical studies were performed, the "data" would refer to test cases, models, or simulated data used in the non-clinical verification. The origin of this data is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. Since no clinical studies or expert consensus activities are described for establishing ground truth on a test set, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/None specified. No adjudication method is mentioned as there were no clinical studies.

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:

No MRMC comparative effectiveness study was conducted. The device is a Radiation Treatment Planning (RTP) system, not an AI-assisted diagnostic tool that would typically involve human readers in this context. The document explicitly states "No animal or clinical tests were performed."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document describes "Design verification and performance testing" and focuses on the system's ability to calculate dose, perform image manipulation, optimization, etc., which implies a standalone performance evaluation of the software components. However, specific performance metrics for the algorithm only without any human interaction involved in setting up the plan or interpreting the output are not quantified. The mention of "Software verification testing" suggests an evaluation of the algorithm's correctness.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing, the "ground truth" would likely be established through:
- Reference data/models: For dose calculations, comparison against established physics models, phantom measurements, or other validated dose calculation systems.
- Known input/output pairs: For software functionalities like image manipulation or contouring, where the expected output for a given input is pre-defined.
- Compliance with standards: The document lists several ISO and IEC standards (e.g., ISO 62083 for radiotherapy treatment planning systems), implying that meeting the requirements of these standards serves as a form of "ground truth" for safety and performance.

8. The sample size for the training set:

Not applicable/Not specified. The document does not describe the device as employing machine learning or AI that would require a "training set" in the conventional sense for a diagnostic algorithm. It describes a physics-based dose calculation and treatment planning system.

9. How the ground truth for the training set was established:

Not applicable. As no training set is described, there's no information on how its ground truth would be established.

In summary, the provided document is a 510(k) premarket notification for an updated Radiation Treatment Planning (RTP) system. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical verification and validation testing against design requirements and recognized standards, rather than providing details of a clinical study or specific quantitative acceptance criteria and performance data.

Summary

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February 23, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is in blue. The logo is simple and clean, and it is easily recognizable.

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

Re: K223233

Trade/Device Name: Monaco RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: January 26, 2023 Received: January 27, 2023

Dear 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

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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 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner. The date of the signature is February 23, 2023, and the time is 14:51:34 -05'00'.

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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) K223233

Device Name

Monaco RTP System

Indications for Use (Describe)

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: • contouring

· image manipulation
· simulation
· image fusion
· plan optimization
QA and plan review

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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Image /page/3/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic with three dots inside, followed by the word "Elekta" in a sans-serif font. The graphic and the text are both in a teal color.

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:	K223233
Date Prepared:	14 October 2022
II. DEVICE
Trade Name:	Monaco Radiation Therapy Planning (RTP) System
Product Classification:	Class II
Common Name:	Radiation Treatment Planning System
Regulation Number:	21 CFR § 892.5050
Regulation Description:	Medical charged-particle radiation therapy system
Product Code:	MUJ

lll. PREDICATE DEVICE

Predicate Device: Monaco RTP System (K213787)

IV. DEVICE DESCRIPTION

The parameters of the plan are output for later reference and for inclusion in the patient file. Monaco planning methods and modalities:

. Intensity Modulated Radiation Treatment (IMRT) planning
Electron, photon and proton treatment planning •
Planning for dynamic delivery methods (e.g. dMLC, dynamic conformal, •
Volumetric Modulated Arc Therapy (VMAT))

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Image /page/4/Picture/0 description: The image shows the logo for Elekta, a company that specializes in radiation therapy and oncology informatics. The logo consists of a stylized circle with three dots inside, followed by the word "Elekta" in a sans-serif font. The circle and the word "Elekta" are both in a teal color. The logo is simple and modern, and it is easily recognizable.

. Stereotactic planning and support of cone-based stereotactic
3D conformal planning
. Adaptive planning (e.g. for the Elekta Unity MR-Linac)
Monaco basic systems tools, characteristics, and functions:
Plan review tools
Manual and automated contouring tools
DICOM connectivity
. Windows operating system
Simulation
Support for a variety of beam modifiers (e.g. MLCs, blocks, etc.)
. Standardized uptake value (SUV)
. Specialty Image Creation (MIP, MinIP, and Avg)
. Monaco dose and Monitor Unit (MU) calculation:
. Dose calculation algorithms for electron, photon, proton planning

Monaco is programmed using C and C++ computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.

INTENDED USE / INDICATIONS FOR USE V.

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton treatment plans and displays, on-screen and in hard-copy, two- or three- dimensional radiation dose distributions inside patients for given treatment plan set-ups.

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

contouring ●
image manipulation
simulation
image fusion ●
plan optimization
. QA and plan review

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE

Monaco RTP System version 6.2 is an updated version of the predicate device and has identical intended use and technological characteristics (identical designs, principles of operation, and use environments) as well as the same indications for use as the predicate device cleared per K213787.

The similarities and differences in key device characteristics and performance specifications of the current and predicate Monaco configuration are noted in the table below: Through adequate verification, validation and usability evaluations, Elekta has concluded that the differences do not impact the substantial equivalence with the predicate device.

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Image /page/5/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 word "Elekta" in a bold, sans-serif font. The color of the logo is a teal or turquoise shade.

Technological Characteristics Comparison	Monaco(Subject Device)	Monaco(K213787)
Dose CalculationAlgorithms	Monte Carlo - electron & photon (extended to includeLET calculation for proton)Collapsed Cone (photon)Pencil Beam (optimization only) GPUMCD for MR-linacGPUMCD for protonProton Pencil Beam	✓	✓
Proton Planning	Robustness optimization/evaluation, calculation usingGPU basedMonte Carlo & pencil beam algorithms and linearenergy transfer (LET) evaluation capabilities will beavailable for Proton Arc Therapy planning.	✓	✓*
MR-Linac dosecalculation	Calculates dose for MR-Linac dose calculation(including magnetic field, coils & cryostat)	✓	✓
Modality support	Supports IMRT, IGRT, particle therapy, stereotacticradiotherapy and MR-Linac treatments	✓	✓
Motion Managementfor MR-LINAC(Elekta Unity)	Adaptive Therapy with optional BLS (Baseline Shift)Recovery	✓	X
Beam Modelling	Beam modeling is performed by Elekta personnel.Standardized beam models are provided for someElekta linac energy options.A new version of the Beam Modelling tool will be madeavailable for users of Monaco 6.2 with a new GPUMCDdose calculator.	✓	✓
DICOM Connectivity	DICOM connectivity with compatible systems	✓	✓
Operating System	Windows operating system Support for Windows 10	✓	✓

*Same features made available to Proton Arc Therapy planning

SUMMARY OF PERFORMACE TESTING (NON-CLINICAL) VII.

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.

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 quidance 1 for devices that pose a major level of concern (Class C per IEC 62304).

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.

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

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Image /page/6/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The graphic is a teal circle with three smaller teal circles inside of it. The word "Elekta" is also teal.

Standard No.	Standard Title
ISO 14971	Medical Devices – Application of risk management to medical devices
IEC 62304	Medical device software - Software life-cycle processes
ISO 62083	Medical electrical equipment - Requirements for the safety ofradiotherapy treatment planning systems
IEC 61217	Radiotherapy equipment - Coordinates, movements and scales
IEC 62366-1	Medical devices - Application of usability engineering to medical devices
ISO 15223	Medical devices -Symbols to be used with medical devices, labeling andinformation to be supplied - Part 1: General requirements

VIII. 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 Monaco is as safe and effective and performs as well as the predicate device.

SUBSTANTIAL EQUIVALENCE CONCLUSION IX.

Monaco is substantially equivalent (SE) to the predicate device, Monaco (K213787). 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 additional motion management strategies 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 pre-determined performance criteria, FDA guidance, and recognized consensus standards.

The results of verification and validation as well as conformance to relevant safety standards demonstrate that Monaco 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.