RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.

The system functionality can be configured based on user needs.

Device Description

RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines.

RayStation consists of multiple applications:

. The main RayStation application is used for treatment planning.
. The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.

The device to be marketed, RayStation 11B, contains modified features compared to RayStation 11.0 as indicated below:

A simplified license configuration of RayStation is marketed as RayPlan. RayPlan has a limited set of purchasable licenses and some modules will not be accessible. RayPlan is marketed as RayPlan 11B.

EQD2 dose computation (new) - From photon and/or braction doses, it is possible to compute, deform and accumulate the two Gray equivalent (EQD2) dose. The computation of the EQD2 dose uses the biological linear quadratic model, which is also the basis for the already released biological optimization and evaluation functionality.

Generation of synthetic CT from CBCT (new) - Two new methods (algorithms) for synthetic CT generation will be included. The synthetic CT images are created by combining information in the CBCT image and a CT image for the specific patient to allow for dose computation using the HU values in the image, as for regular CT images. In RayStation 11.0 it is possible to compute dose on CBCT images for photons using bulk density assignments. The added functionality will improve the photon dose calculation accuracy on CBCT images. Handling of LET and other RBE components (new) - This functionality enables possibility to compute and evaluate the dose weighted LET (Linear Energy Transfer) for proton and light ion plans. LET is an additional dosimetric measure that can be used to assess the radiobiological effect of the proton and light ion radiation. Radiobiological equivalent (RBE) dose is a derived quantity with dependence on both the physical dose and the LET. In RayStation 11.0, it is possible to compute and evaluate RBE doses.

AI/ML Overview

The provided text describes a 510(k) submission for RayStation 11B, a radiation therapy treatment planning system. However, the document does not contain the detailed information required to answer many of the questions about acceptance criteria and the study that proves the device meets them, especially regarding the performance of a machine learning component if one exists and its specific acceptance criteria.

The document states: "Related to machine learning, there is no change compared to the predicate device." This implies that while the RayStation product family might have machine learning components, RayStation 11B does not introduce new machine learning features that would necessitate specific performance studies for acceptance as part of this 510(k) submission. The focus of the provided text is on the validation of new dose computation methods and synthetic CT generation.

Therefore, many sections below will indicate "Information Not Provided in Text" or state that the question is not applicable given the document's content.

Acceptance Criteria and Reported Device Performance

Given the information provided, the acceptance criteria are largely related to the successful verification and validation of the new features (EQD2 dose computation, synthetic CT generation from CBCT, and handling of LET and other RBE components) demonstrating that the dose computations are "adequate for clinical use" and that the system "has met specifications and is as safe, as effective and performs as well as or better than the legally marketed predicate device."

Without specific numerical thresholds or performance metrics in the provided text, a formal table of acceptance criteria and reported performance cannot be fully constructed for these new features. The document suggests that the previous predicate device's performance benchmarks likely served as the implicit standard for "as well as or better than."

Implicit Acceptance Criteria and Reported Performance (based on text):

Acceptance Criterion	Reported Device Performance
EQD2 dose computation is adequate for clinical use.	Validation for photon and/or braction doses were validated as part of the Clinical Evaluation for Brachy and User Site Validation demonstrates that the dose computation adequate for clinical use.
Improved photon dose calculation accuracy on CBCT images for synthetic CT from CBCT is adequate for clinical use.	Validation of improved photon dose calculation accuracy on CBCT images was performed in CBCT Conversion validation demonstrates that the dose computation adequate for clinical use.
Handling of LET and other RBE components for proton and light ion plans is adequate for clinical use.	Validation of dose weighted LET (Linear Energy Transfer) for proton and light ion plans were performed as part of the Proton PBS Monte Carlo validation. The validation demonstrates that the dose computation adequate for clinical use.
Overall system meets specifications and is as safe, as effective, and performs as well as or better than the predicate device.	"The data obtained from the verification show that system tests, unit and subsystem tests have passed, and the validations been completed successfully. The reviews of design, code and labeling are also passed."

Study Information

A table of acceptance criteria and the reported device performance
See table above. Specific numerical thresholds are not provided in the text.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Sizes: Not explicitly stated for any of the validations (e.g., Clinical Evaluation for Brachy, CBCT Conversion validation, Proton PBS Monte Carlo validation). The text mentions "User Site Validation," which implies real-world data, but details on the number of cases or patients are absent.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective or Prospective: Not specified. "User Site Validation" might imply prospective or real-world use data, but this is not confirmed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Mention of "User Site Validation in cooperation with cancer clinics" suggests involvement of clinical professionals, but their specific roles, number, or qualifications are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- An MRMC study is not mentioned for the new features. The document explicitly states: "Related to machine learning, there is no change compared to the predicate device." This indicates that no new AI-assisted workflows requiring human reader improvement studies were part of this submission. The validation efforts focus on the accuracy of the new computational functions themselves, not human-AI interaction.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the validation activities described (e.g., "EQD2 dose computation (new) – Validation," "Generation of synthetic CT from CBCT (new) – Validation," "Handling of LET and other RBE components (new) - Validation") are, by their nature, evaluations of the algorithm's performance in generating accurate dose calculations or synthetic CTs. These are standalone evaluations of the new features. The "User Site Validation" is likely a real-world system test, but the core 'algorithm-only' performance is implied by the specific validation names.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The term "ground truth" is not explicitly used, but the validation implies comparisons against established or expected physical and radiobiological models and potentially clinical standards of care.
  - For dose computation, validation would typically involve comparing computed doses against known physics models, phantom measurements, or existing clinical systems deemed accurate.
  - For synthetic CT, the "ground truth" would likely be the actual CT data that the synthetic CT is intended to replicate or approximate for dose calculation purposes.
- The text doesn't specify if clinical outcomes were used as ground truth for these specific validations.
The sample size for the training set
- Information Not Provided in Text. The document states "Related to machine learning, there is no change compared to the predicate device," and the new features are described as "algorithms" or "functionality," not explicitly machine learning models that would require a distinct training set for this submission. If the original RayStation product had ML components, their training set information is not part of this document.
How the ground truth for the training set was established
- Information Not Provided in Text. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of RayStation 11B to its predicate device by verifying and validating new computational features rather than new or modified AI/ML features requiring human-in-the-loop or specific training/test set performance metrics commonly associated with AI/ML device clearances. The acceptance criteria are implicitly tied to the successful completion of these verification and validation activities, proving the new functions are "adequate for clinical use" and the system performs "as well as or better than" the predicate.

Summary

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RaySearch Laboratories AB (publ) % David Hedfors Quality and Regulatory Affairs Director Eugeniavägen 18 Stockholm. 113 68 Sweden

Re: K220141

Trade/Device Name: RayStation 11B Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: January 10, 2022 Received: January 18, 2022

Dear David Hedfors:

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,

Julie Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy 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) K220141

Device Name RayStation 11B

Indications for Use (Describe)

The system functionality can be configured based on user needs.

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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K220141

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510(k) Summary

RayStation 11B

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Document ID and Title	Version:
510(k) Summary RayStation 11B	1.0

1.	510(k) Summary	3
	1.1 510(k) owner	3
	1.2 Contact person	3
	1.3 Preparation date	3
	1.4 Trade name	3
	1.5 Common name	3
	1.6 Classification name	3
	1.7 Predicate devices	3
	1.8 Device description	3
	1.9 Intended use	4
	1.10 Technological characteristics summary	4
	1.11 Assessment of non-clinical performance data	4
	1.12 Test conclusion	4

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Document ID and Title

510(k) Summary RayStation 11B

Version:

1.0

510(k) Summary

1.1 510(k) owner

RaySearch Laboratories AB (publ) Eugeniavägen 18 113 68 Stockholm Sweden

Tel: +46 8 510 530 00

1.2 Contact person

David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) quality@raysearchlabs.com Email: +46 722 366 110 Tel:

Preparation date 1.3

January 10th, 2022

1.4 Trade name

The trade name is RayStation.

The marketing name is RayStation 11B and RayPlan 11B.

1.5 Common name

Radiation therapy treatment planning system

1.6 Classification name

Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)

1.7 Predicate devices

K211867 RayStation 11.0

1.8 Device description

RayStation consists of multiple applications:

. The main RayStation application is used for treatment planning.
. The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.

The device to be marketed, RayStation 11B, contains modified features compared to RayStation 11.0 as indicated below:

A simplified license configuration of RayStation is marketed as RayPlan. RayPlan has a limited set of purchasable licenses and some modules will not be accessible. RayPlan is marketed as RayPlan 11B.

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Document ID and Title	Version:
510(k) Summary RayStation 11B	1.0

1.9 Intended use

The system functionality can be configured based on user needs.

1.10 Technological characteristics summary

The technological characteristics are the same for RayStation 11B as for the predicate device RayStation 11.0. Both versions are built on the same software platform and share design to a high degree. Both versions have been developed under the same quality system, by the same development teams, meeting the same requirements for safety and effectiveness.

The device to be marketed, RayStation 11B contains new features as indicated below:

. EQD2 dose computation (new)
. Generation of synthetic CT from CBCT (new)
Handling of LET and other RBE components (new)

Related to machine learning, there is no change compared to the predicate device.

1.11 Assessment of non-clinical performance data

The test specification of RayStation 11B is a further developed version of the test specification of RayStation 11.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 11B therefore support the substantial equivalence of the above RayStation versions.

EOD2 dose computation (new) – Validation for photon and/or braction doses were validated as part of the Clinical Evaluation for Brachy and User Site Validation demonstrates that the dose computation adequate for clinical use.

Generation of synthetic CT from CBCT (new) – Validation of improved photon dose calculation accuracy on CBCT images was performed in CBCT Conversion validation demonstrates that the dose computation adequate for clinical use.

Handling of LET and other RBE components (new) - Validation of dose weighted LET (Linear Energy Transfer) for proton and light ion plans were performed as part of the Proton PBS Monte Carlo validation. The validation demonstrates that the dose computation adequate for clinical use.

1.12 Test conclusion

The determination of substantial equivalence is not based on an assessment of non-clinical performance data. However, the entire system verification and validation specifications and reports are included in the submission as required by a software device of major concern.

A number of different types of verification activities have been performed:

. System Tests of RayStation

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Risk analysis-based tests for use error mitigation verification ●
. Unit and subsystem testing for low-level testing
. Dose engine validation including internal testing
User validation in cooperation with cancer clinics
. Reviews of design, code and Master Labeling

The data obtained from the verification show that system tests, unit and subsystem tests have passed, and the validations been completed successfully. The reviews of design, code and labeling are also passed.

From the successful verification and validation activities, the conclusion can be drawn that RayStation 11B has met specifications and is as safe, as effective and performs as well as or better than the legally marketed 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.

Acceptance Criteria and Reported Device Performance

Study Information

Indications for Use

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

510(k) Summary

Table of Contents

510(k) Summary

1.1 510(k) owner

1.2 Contact person

Preparation date 1.3

1.4 Trade name

1.5 Common name

1.6 Classification name

1.7 Predicate devices

1.8 Device description

1.9 Intended use

1.10 Technological characteristics summary

1.11 Assessment of non-clinical performance data

1.12 Test conclusion

§ 892.5050 Medical charged-particle radiation therapy system.