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 6.0 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 document is describing a 510(k) premarket notification for a medical device (RayStation 6.0), which aims to show substantial equivalence to a predicate device (RayStation 5.0). The provided text describes the software's functionality and its intended use but does not contain details about a study with acceptance criteria and device performance data in the context of an AI/human reader comparative study or standalone algorithm evaluation.

The sections "5.11 Assessment of non-clinical performance data" and "5.12 Test conclusion" briefly state that "The test specification of RayStation 6.0 is a further developed version of the test specification of RayStation 5.0" and that "The successful verification and validation of RayStation 6.0 therefore support the substantial equivalence of the above RayStation versions." However, it does not provide any specific acceptance criteria or performance metrics.

Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text. The document focuses on regulatory submission aspects (e.g., 510(k) summary, intended use, technological characteristics comparison to a predicate device) rather than clinical performance data with specific acceptance criteria.

To answer your request, I would need a document that presents:

Specific quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds).
The actual reported performance of the device against these criteria.
Details about the study design (sample size, data provenance, ground truth establishment, reader studies if applicable).

Summary

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

March 2, 2017

RaySearch Laboratories AB (publ) % Mr. David Hedfors Quality and Regulatory Affairs Director Sveav 44 Stockholm, 111 34 SWEDEN

Re: K170355 Trade/Device Name: RayStation 6 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: February 1, 2017 Received: February 6, 2017

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'Hara
For

Robert Ochs. Ph.D. 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) K170355

Device Name RayStation 6

Indications for Use (Describe)

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.

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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Document ID and Title	Version:
RSL-D-RS-6.0 Traditional 510(k) Submission RayStation 6.0	1.0

5. 510(k) Summary

5.1 510(k) owner

RaySearch Laboratories AB (publ) Sveavägen 44 111 34 Stockholm Sweden

Tel: +46 8 510 530 00

5.2 Contact person

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

5.3 Preparation date

February 1st, 2017

5.4 Trade name

The trade name is RayStation.

The trade name and version number are written together, i.e. "RayStation 6.0" to easily distinguish the submitted device from the predicate device RayStation 5.0.

5.5 Common name

Radiation therapy treatment planning system

5.6 Classification name

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

5.7 Predicate device

RayStation 5.0 K160093

5.8 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 6.0
2. The user imports a patient and case withCT images through DICOM	3. The system imports the data and checksconsistency of in-data
4. The user enters the Structure Definitionmodule and creates ROIs using thecontouring tools	5. The system adds the ROIs to the patientcase
6. The user enters the Plan Setup module andcreates a plan and a treatment setup withspecified machine, treatment energy and

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Document ID and Title	Version:
RSL-D-RS-6.0 Traditional 510(k) Submission RayStation 6.0	1.0
7. The user specifies beam configurationincluding isocenter, dose grid and fluencegrid resolution	8. The system adds the plan and treatmentsetup to the patient case
9. The user enters the Plan Optimizationmodule 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 Evaluationmodule and evaluates the plan	15. The system exports the plan and patientdata to a DICOM server
14. The user approves and exports the plantogether with dose, structure sets andimages

5.9 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 6.0 is the same as for the predicate device RayStation 5.0.

5.10 Technological characteristics summary

The technological characteristics are the same for RayStation 6.0 as for the predicate device RayStation 5.0.

Comparing RayStation 6.0 with RayStation 5.0, 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.

5.11 Assessment of non-clinical performance data

The test specification of RayStation 6.0 is a further developed version of the test specification of RayStation 5.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 6.0 therefore support the substantial equivalence of the above RayStation versions.

5.12 Test conclusion

The summary of the performed non-clinical tests shows that RayStation 6.0 is as safe and effective, and performs as well as 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.