RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

The system functionality can be configured based on user needs.

The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Device Description

RayStation 4.5 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on one platform.

AI/ML Overview

This is a premarket notification for RayStation 4.5, a radiation therapy treatment planning system. The document states that successful verification and validation of RayStation 4.5 support its substantial equivalence to the predicate device, RayStation 4.0.2. However, it does not explicitly define acceptance criteria or detail a specific study with performance metrics for RayStation 4.5. Instead, it refers to the predicate device and the continuation of testing specifications.

Therefore, many of the requested details about acceptance criteria, specific study results, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text.

Based on the available information:

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

The document does not explicitly state acceptance criteria or provide a table of reported device performance metrics in numerical terms. It broadly states that "The successful verification and validation of RayStation 4.5 therefore support the substantial equivalence of the above RayStation versions." This implies that the device met internal verification and validation requirements, which would include performance benchmarks, but these are not disclosed.

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

Not specified in the provided text.

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

Not specified in the provided text.

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

Not specified in the provided text.

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:

Not applicable. The RayStation is a treatment planning system, not a diagnostic AI device requiring human reader improvement comparison.

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

The device is a "software system designed for treatment planning and analysis of radiation therapy." Its performance is inherently "standalone" in generating plans and dose estimates, but these plans are "used to administer treatments after review and approval by the intended user," indicating a human-in-the-loop for clinical application. The document describes a workflow where the user launches RayStation, imports data, creates ROIs, sets up a plan, optimizes it, reviews it, evaluates it, and approves/exports it. This confirms a human-in-the-loop process for clinical use, not a purely standalone AI interpretation.

7. The type of ground truth used:

Not explicitly stated. For a radiation therapy treatment planning system, ground truth would typically revolve around the accuracy of dose calculations, adherence to prescribed dose targets, and safety parameters. This would involve comparisons against established physics models, phantom measurements, and potentially retrospective patient data.

8. The sample size for the training set:

Not applicable. This document describes a software update (RayStation 4.5) to an existing product (RayStation 4.0.2). It is not a de novo AI device that would typically have a distinct "training set" in the machine learning sense. The development likely involved traditional software engineering, verification, and validation processes.

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

Not applicable for the reasons mentioned above. Development of this type of software would rely on established physics principles, clinical guidelines, and previous version's validated performance rather than a specific "training set ground truth."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 23, 2014

RaySearch Laboratories AB % Mr. David Hedfors Quality And Regulatory Affairs Manager Sveav 25. Plan 9 Stockholm, 111 34 SWEDEN

Re: K141860 Trade/Device Name: RayStation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 21, 2014 Received: August 25, 2014

Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K141860

Device Name: RayStation 4.5

Indications for Use:

The system functionality can be configured based on user needs.

The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 1 of 1

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Title:	Document ID:	Version:
RayStation 4.5	RSL-D-61-227	1.0

7. 510(k) Summary

7.1 510(k) owner

RaySearch Laboratories AB Sveavägen 25, floor 9 111 34 Stockholm Sweden

Tel: +46 (8) 54506130 +46 (8) 54506139 Fax:

7.2 Contact person

David Hedfors Quality and Regulatory Affairs Manager david.hedfors@raysearchlabs.com

7.3 Preparation date

June 27, 2014

7.4 Trade name

RayStation

Trade name and version number are often combined, i.e. "RayStation 4.5", to easily distinguish the submitted device from the predicate device RayStation 4.0.2.

7.5 Common name

Radiation Therapy Treatment Planning System

7.6 Classification name

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

7.7 Predicate device

RayStation 4.0.2 K140187

7.8 Device description

The main workflow, creating a treatment plan from imported patient image data, is described below:

Flow of Events
User	System
1. The user launches RayStation 4.5
2. The user imports a patient and case with CT images through DICOM	3. The system imports the data and checks consistency of in-data
4. The user enters the Structure Definition module and creates ROIs using the contouring tools	5. The system adds the ROIs to the patient case
6. The user enters the Plan Setup module and creates a plan and a treatment setup with specified machine, treatment energy and delivery type

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Title:RayStation 4.5	Document ID:RSL-D-61-227	Version:1.0
7. The user specifies beam configuration including isocenter, dose grid and fluence grid resolution	8. The system adds the plan and treatment setup to the patient case
9. The user enters the Plan Optimization module and optimizes the plan parameters	10. The system generates a deliverable plan11. The system displays the plan as- 2D and 3D dose and patient displays- DVH curves- Plan data (beams, segments etc.)
12. The user reviews the plan13. The user enters the Plan Evaluation module and evaluates the plan14. The user approves and exports the plan together with dose, structure sets and images	15. The system exports the plan and patient data to a DICOM server

7.9 Intended use

The system functionality can be configured based on user needs.

The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

The intended use for RayStation 4.5 is the same as for the predicate device RayStation 4.0.2.

7.10 Technological characteristics summary

The technological characteristics are the same for RayStation 4.5 as for the predicate device RayStation 4.0.2.

Comparing RayStation 4.5 with RayStation 4.0.2, the newer version includes usability, computational speed and connectivity improvements. 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 meeting the same requirements for safety and effectiveness.

The test specification of RayStation 4.5 is a further developed version of the test specification of RayStation 4.0.2. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 4.5 therefore support the substantial equivalence of the above RayStation versions.

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.