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 4.0.2 is a treatment planning system, i.e. a software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing rival plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.

AI/ML Overview

The provided text is a 510(k) Summary for RayStation 4.0.2, a radiation treatment planning system. However, it does not contain specific acceptance criteria or a detailed study description with performance metrics, sample sizes, ground truth establishment, or expert qualifications necessary to fully answer your request.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (RayStation 3.5 and XiO RTP System) through a general description of functionalities, technological characteristics, and a summary of non-clinical performance data.

Here's a breakdown of what can be extracted and what information is missing based only on the provided text:

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

Missing Information: The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" metrics in the way you've requested (e.g., sensitivity, specificity, accuracy, dice scores, etc.).
What is reported: The document states that "The summary of the performed non-clinical tests shows that RayStation 4.0.2 is as safe and effective, and performs as well as the predicate devices." This is a qualitative statement of equivalence rather than a quantitative performance metric against specific criteria.

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

Missing Information: The document does not specify any sample sizes for test sets (e.g., number of patient cases, images).
Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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

Missing Information: This information is not provided. The document refers to "verification and validation" and "test results" but does not describe the methodology of establishing ground truth or the involvement of experts in this process for a test set.

4. Adjudication method for the test set

Missing Information: No adjudication method (e.g., 2+1, 3+1, none) is mentioned.

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

Missing Information: The document makes no mention of an MRMC study or any AI components, nor does it discuss human reader improvement with or without assistance. The device described is a treatment planning system, not an AI-assisted diagnostic tool in the sense implied by this question.

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

Missing Information: No information is provided about standalone performance studies for an "algorithm only" where the context suggests AI. The device is a "treatment planning system," implying human interaction is integral.

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

Missing Information: The document does not specify the type of ground truth used for any testing. It mentions "verification performed for proton planning verifies the functionality for - Proton planning treatment plan calculation, - Proton energy range estimation, - Proton dose calculation, - Pencil Beam Scanning (PBS)." This suggests a ground truth related to physical accuracy of calculations, but how this ground truth was established (e.g., comparison to gold standard physics measurements, theoretical models) is not detailed.

8. The sample size for the training set

Missing Information: As the document describes a traditional software system rather than a machine learning/AI model, the concept of a "training set" in the context of deep learning is not applicable here, and therefore, no sample size for training is provided.

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

Missing Information: Not applicable as per point 8.

Summary of Study Information Provided:

The document describes a non-clinical performance data assessment to support substantial equivalence. The "study" appears to be a verification and validation (V&V) process against internal requirements and the functionalities of predicate devices.

"General Technology" V&V: The test specification for RayStation 4.0.2 is a "further developed version of the test specification of RayStation 3.5," supported by similar requirements specifications. The "successful verification and validation" of 4.0.2 supports its substantial equivalence to previous RayStation versions.
"Proton Planning" V&V: Verification was performed for specific proton planning functionalities: treatment plan calculation, energy range estimation, dose calculation, and Pencil Beam Scanning (PBS). These are stated to be the "same functionality as included in the predicate device XiO RTP System."

Conclusion based on provided text:

The 510(k) submission for RayStation 4.0.2 relies on demonstrating substantial equivalence to its predicate devices through internal verification and validation of its expanded functionalities (especially PBS for proton planning). It asserts that the tests performed show the device is "as safe and effective, and performs as well as the predicate devices." However, it does not provide the detailed study characteristics, quantitative acceptance criteria, or performance metrics typically associated with studies for AI/ML-based medical devices. The information supplied is typical for a traditional software update where V&V against existing requirements and functionalities is the primary means of demonstrating safety and effectiveness.

Summary

{0}------------------------------------------------

Title:	Document ID:	Version:
510(k) Submission RayStation 4.0.2	RSL-D-61-04	1.0

510(k) Summary 5.

510(k) owner 5.1

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

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

5.2 Contact person

Ladan Amiri, Sr. Quality and Regulatory Affairs Engineer

5.3 Preparation date January 14, 2014

5.4 Trade name

RayStation

Trade name and version number are written together, i.e. "RayStation 4.0.2" to easily distinguish the submitted device from the predicate device RayStation 3.5.

5.5 Common name

Radiation treatment planning system

5.6 Classification name

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

5.7 Predicate devices

RayStation 3.5	K130617
XiO RTP System	K102216

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 4.0.2
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 (SMLC)

{1}------------------------------------------------

Title:· A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A -	Document ID:	Version:
and of the super for seems of the bearing the first for the first for the first and the first of the first of the first of the first for the first for the first for the first510(k) Submission RayStation 4.0.2	RSL-D-61-04	14.40

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 creates an optimization problem
10.	The user defines the algorithm and segmentation settings and starts the optimization	11.	The system generates a deliverable step-and-shoot plan
		12.	The system displays the plan as- 2D and 3D dose and patient displays- DVH curves- Plan data (beams, segments etc.)
13.	The user reviews the plan
14.	The user enters the Plan Evaluation module and evaluates the plan
15.	The user approves and exports the plan together with dose, structure sets and images	16.	The system exports the plan and patient data to a DICOM server

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 4.0.2 is the same as for the predicate device RayStation 3.5.

Technological characteristics summary 5.10

5.10.1 General technology

The technological characteristics are the same for RayStation 4.0.2 as for the predicate device RayStation 3.5.

Comparing RayStation 4.0.2 with RayStation 3.5, the newer version includes usability, performance and connectivity improvements. Both versions are built on the same software platform and share basic design. Both versions have been developed under the same quality system meeting the same requirements for safety and effectiveness.

5.10.2 Proton planning with Pencil Beam Scanning (PBS)

The proton planning functionality in RayStation 3.5 is extended in RayStation 4.0.2 by adding Pencil Beam Scanning (PBS) functionality.

The RayStation 4.0.2 proton planning with Pencil Bam Scanning (PBS) technology is substantially equivalent to the predicate device XiO RTP System - Proton Spot Scanning.

{2}------------------------------------------------

` Title:	Document ID:	Version
510(k) Submission RayStation 4.0.2But a sua change a comments a comments of the	L-D-61-0412 C 1	COLL LE CLAIN CHARGE CHANNELL

Comparing RayStation 4.0.2 and XiO RTP Systems give the user the ability to crate proton treatment plans that involve a series of small proton beams for which dose and monitor units are calculated and displayed individually. This allows users to create intensity modulated ration therapy (IMRT) plans with protons.

5.11 Assessment of non-clinical performance data

5.11.1 General technology

The test specification of RayStation 4.0.2 is a further developed version of the test specification of RayStation 3.5. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 4.0.2 therefore support the substantial equivalence of the above RayStation versions.

5.11.2 Proton planning

The verification performed for proton planning verifies the functionality for

Proton planning treatment plan calculation .
Proton energy range estimation .
Proton dose calculation .
Pencil Beam Scanning (PBS) .

This is the same functionality as included in the predicate device XiO RTP System. The test results thereby support a determination of substantial equivalence.

5.12 Test conclusion

The summary of the performed non-clinical tests shows that RayStation 4.0.2 is as safe and effective, and performs as well as the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three wavy lines representing the serpent and a stylized staff.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 15, 2014

RaySearch Laboratories AB % Ms. Ladan Amiri Sr. Quality and Regulatory Affairs Engineer Sveavagen 25, plan 9 111 34 Stockholm SWEDEN

Re: K140187 Trade/Device Name: RayStation 4.0.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 13, 2014 Received: April 16, 2014

Dear Ms. Amiri:

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 (2 l 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.

{4}------------------------------------------------

Page 2—Ms. Amiri

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" (21CFR 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/Industrv/default.htm.

Sincerely yours,

Smh.7)

for

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

Enclosure

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140187

Device Name RayStation 4.0.2

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.7)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete tind to review the collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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.