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

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

Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009. when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179), again when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Specialty image creation was added in 2015 (K151233), and adaptive planning and dose calculation in the presence of a magnetic field (e.g., MR-Linac) was added in 2018 (K183037). A 510(k) was filed in 2017 for the addition of carbon ion planning. The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans. Monaco's carbon ion planning functionality remains licensed off and inaccessible to US users.

The Monaco system accepts patient imaging data and "source" dosimetry data 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 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. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the clinican prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.

Monaco 6.00 supports Proton Pencil Beam Scanning (Proton PBS) planning for IBA Proteus®ONE and Proteus®PLUS delivery systems (Ion Beam Applications S.A.).

AI/ML Overview

The provided text is a 510(k) summary for the Elekta Monaco RTP System. It describes the device, its intended use, and a comparison to predicate devices, but it explicitly states that "Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Validation testing involved simulated clinical workflows using actual patient data, such as patient images. Pre-defined pass/fail criteria were also equivalent to that of the previous version of Monaco."

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets them in the way you've outlined, as there was no clinical study (MRMC, standalone, etc.) involving human readers or a traditional test set/ground truth establishment as would be done for an AI-based diagnostic device.

The study referenced is a non-clinical verification study that focuses on software functionality, safety, and effectiveness compared to an existing predicate device, primarily through regression testing and verification of new functionalities. The acceptance criteria are "pre-defined pass/fail criteria" that were equivalent to those used for the previous version of Monaco.

However, based on the information provided, I can infer and summarize what was done:

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

The document broadly states that "Pre-defined pass/fail criteria were also equivalent to that of the previous version of Monaco." and "Conformity to the same pass/fail criteria as the predicate version of Monaco indicated that Monaco 6.00 was substantially equivalent in safety and effectiveness."

While specific numeric acceptance criteria and performance metrics are not detailed in this summary, the overall acceptance criterion was Substantial Equivalence to the predicate devices. The performance reported is that "Monaco 6.00 was deemed safe and effective for its intended use" based on the non-clinical testing.

Acceptance Criteria (Internal Software Validation/Verification)	Reported Device Performance (Summary)
Equivalence to previous Monaco version's pass/fail criteria	Deemed safe and effective, and substantially equivalent
Verification of new product functionality (e.g., Proton PBS)	"System is working as designed"
Risk mitigations functioning as intended	Ensured continued safety and effectiveness
Regression tests to ensure continued safety and effectiveness	Ensured continued safety and effectiveness for existing functionality
Conformity to FDA Quality System Regulation (21 CFR §820)	Met regulations
Conformity to ISO 13485 Quality Management System standard	Met standards
Conformity to IEC 62304 Software Life Cycle standard	Met standards
Conformity to ISO 14971 Risk Management Standard	Met standards

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

Sample Size for Test Set: The document mentions "Over 600 test procedures were executed" and "Validation testing involved simulated clinical workflows using actual patient data, such as patient images." The exact number of patient datasets or specific test cases within those 600 procedures is not specified.
Data Provenance: "actual patient data, such as patient images." No specific country of origin is mentioned, but "simulated clinical workflows" suggests internally generated or existing de-identified data. The testing was retrospective in the sense that it used pre-existing patient data for simulation, not prospective patient enrollment.

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

This wasn't a ground truth establishment study for a diagnostic AI. The "ground truth" for this system's validation was primarily the expected output of the algorithms (e.g., dose calculations, plan optimizations) as per documented specifications and comparisons to known good results from the predicate device.
The document states that "Once completed, plans are reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place." This implies that the system is used by "Dosimetrist or Medical Physicist" and reviewed by "qualified clinicians" in a clinical setting, but these roles were not part of a formal "ground truth" establishment for the validation study itself.

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

Not applicable. This was a software verification and validation against specified requirements and predicate performance, not a clinical adjudication of diagnostic findings.

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 performed. The document explicitly states: "Clinical trials were not performed as part of the development of this product." and "Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk."

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

The testing described is essentially a form of "standalone" algorithm verification in a simulated environment, focused on the software's functional correctness for tasks like dose calculation and plan optimization, rather than a diagnostic AI's performance. The product itself is a "Radiation Treatment Planning System," which is inherently a human-in-the-loop device, where the software outputs are reviewed and approved by clinicians before implementation. The verification ensured the software's outputs were correct according to its specifications and predicate performance.

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

The "ground truth" for this validation was primarily derived from:
- Validated algorithms/physical models: For dose calculation, the "ground truth" is based on established physics principles and validated dose calculation algorithms (Monte Carlo, Collapsed Cone, Pencil Beam).
- Predicate device performance: Functional equivalence and similar calculation results to the previously cleared Monaco RTP System (K190178) and RayStation 8.1 (K190387).
- Pre-defined pass/fail criteria: These would be based on engineering specifications, clinical requirements for accuracy in dose distribution, and comparison to known good results for test cases.
- "Simulated clinical workflows using actual patient data": This implies that for these simulated workflows, the expected correct outcome (e.g., the accurate dose distribution for a given patient anatomy and treatment plan) served as the reference.

8. The sample size for the training set:

This device is not an AI/ML model that undergoes a "training" phase in the typical sense (i.e., learning from annotated data). It's a software system built on established algorithms for radiation treatment planning. Therefore, there is no "training set" as would be applicable to a deep learning model.

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

Refer to point 8. Not applicable for this type of device.

Summary

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February 23, 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 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.

Elekta Solutions AB % Irina Proutski Senior Regulatory Affairs Consultant Kungstensgatan 18, Box 7593 Stockholm, SE-103 93 SWEDEN

Re: K202789

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 18, 2021 Received: January 21, 2021

Dear Irina Proutski:

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 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

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Indications for Use

510(k) Number (if known)

K202789

Device Name Monaco RTP System

Indications for Use (Describe)

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, twoor 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

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)

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Image /page/3/Picture/0 description: The image shows the Elekta company logo. The logo consists of a circular graphic to the left of the company name. The graphic is a teal circle with three smaller circles inside of it.

510(K) SUMMARY (21 CFR § 807.92)

SUBMITTER	Elekta Solutions ABKungstensgatan 18 Box 7593Stockholm, Stockholms lan [SE-01] SE SE10393
Contact:	Nickie Power

Nickie Power nickie.power@elekta.com

EstablishmentRegistration Number:	3015232217
510(k) Number:	K202789
Date Prepared:	15 January 2021

II. DEVICE

Trade Name:	Monaco RTP System
Release Version #:	Release 6.00
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

K190178 (Monaco RTP System) Predicate Device 1: Predicate Device 2: K190387 (RayStation 8.1)

IV. DEVICE DESCRIPTION

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Image /page/4/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 written in a teal sans-serif font.

Monaco 6.00 supports Proton Pencil Beam Scanning (Proton PBS) planning for IBA Proteus®ONE and Proteus®PLUS delivery systems (Ion Beam Applications S.A.).

LEVEL OF CONCERN

ltem 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices asks, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems .... " Monaco does not directly control the linear accelerator that delivers the radiation. Once completed, plans are reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place. There is no automatic link between the Monaco software and the linear accelerator. However, should a flaw in the treatment plan escape the notice of the qualified professionals using the Monaco system, serious injury or death could result. Therefore, we believe Monaco to be of major level of concern.

INDICATIONS FOR USE V.

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

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Image /page/5/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 circle with three smaller circles inside of it. The word "Elekta" is written in a sans-serif font.

SUMMARY OF CLINICAL TESTING VI.

Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Validation testing involved simulated clinical workflows using actual patient data, such as patient images. Pre-defined pass/fail criteria were also equivalent to that of the previous version of Monaco. The product was deemed substantially equivalent and fit for clinical use.

VII. SUMMARY OF NON-CLINICAL TESTING

Verification tests were written and executed to ensure that the system is working as designed. Over 600 test procedures were executed, including tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. Verification testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, IEC 62304 Software Life Cycle standard, and ISO 14971 Risk Management Standard, as was the predicate version. Quality System procedures governing the testing process, including pre-defined pass/fail criteria, were equivalent to procedures used in the testing of the previous Monaco version cleared. Conformity to the same pass/fail criteria as the predicate version of Monaco indicated that Monaco 6.00 was substantially equivalent in safety and effectiveness. Monaco 6.00 was deemed safe and effective for its intended use.

Feature	Monaco(subject device)	MonacoPredicate DeviceK190178	RayStation 8.1Predicate DeviceK190387
Intended use and Indications for use
Contouring	Yes	Yes	Yes
Dose Calculation	Yes	Yes	Yes
Plan Optimization	Yes	Yes	Yes
Image Manipulation & Fusion	Yes	Yes	Yes
CT Simulation	Yes	Yes	Yes
QA/Plan Review	Yes	Yes	Yes
Technological Characteristics
Dose Calculation Algorithms	Monte Carlo(electron & photon),Collapsed Cone(photon), PencilBeam (optimizationonly), GPUMCD forMR-linac, GPUMCDfor proton, ProtonPencil Beam	Monte Carlo(electron & photon),Collapsed Cone(photon), PencilBeam (optimizationonly), GPUMCD forMR-linac	Proton PencilBeam and MonteCarlo, CollapsedCone for photon,Monte Carlo forelectron
Calculates dose for MR-Linac(including magnetic field, coils& cryostat)	Yes	Yes	No
Adaptive therapy features	Yes	Yes	Yes
Calculation and display ofstandardized uptake value	Yes	Yes	Yes
Feature	Monaco(subject device)	MonacoPredicate DeviceK190178	RayStation 8.1Predicate DeviceK190387

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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 circular graphic is teal and has three smaller circles inside of it. The word "Elekta" is also teal and is written in a sans-serif font.

Local Biological MeasureOptimization	Yes	Yes	No
Support for various treatmentaids	Yes	Yes	Yes
Support for Dynamic DeliveryMethods	Yes	Yes	Yes
Operating System	Windows	Windows	Windows
DICOM RT Support	Yes	Yes	Yes
Modalities Supported	Photon, Electron,Proton	Calculates dose forphoton and electronplans only. Forusers with MonacoSim only, partialworkflows withlimited functions areavailable for protonplans	Photon, Electron,Proton
Support for brachytherapy	No	No	No
Interoperable with OIS system	Yes, includingsupport forprescribed relativeoffset (PRO)	Yes, includingsupport forprescribed relativeoffset (PRO)	Yes
Beam modeling	Beam modeling isperformed by Elektapersonnel.Standardized beammodels are providedfor some Elektalinac energy options.	Beam modeling isperformed by Elektapersonnel.Standardized beammodels are providedfor some Elektalinac energy options.	Unknown
Scripting	Yes	No	Yes
Archive/Retrieve	Yes	No	Yes

CONCLUSIONS VIII.

Elekta's Monaco RTP System (subject device) is substantially equivalent to Elekta's Monaco RTP System predicate device cleared under K190178 and RaySerach Laboratories AB's RayStation 8.1 cleared under K190387.

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.