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 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 document is a 510(k) summary for RayStation 1.0, a radiation treatment planning system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a device performance study with quantitative metrics like sensitivity, specificity, or AUC, and associated confidence intervals.

Instead, the closest information regarding "acceptance criteria" and "proof" of meeting them is found in section 5.11:

"The dose algorithm in both RayStation 1.0 and RayAutoplan 1.0 is the same. This is supported by the dose algorithm accuracy testing, which has used the same test specification 1.0 as was previously used for Ray Autoplan 1.0. The tests include dose calculation for a wide variety of field geometries, treatment units, treatment setups and patient positions, including different dose grid resolution settings. All tests were run successfully for RayStation 1.0."

Based on this, here's an attempt to answer your questions, highlighting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Dose algorithm accuracy for a wide variety of field geometries.	The dose algorithm accuracy testing, using the same test specification as Ray Autoplan 1.0, included tests for "a wide variety of field geometries." All tests were run successfully for RayStation 1.0. (No specific quantitative performance metrics like percentage error or gamma index are provided in the summary, just a qualitative "successfully.")
Dose algorithm accuracy for various treatment units.	The dose algorithm accuracy testing included tests for "treatment units." All tests were run successfully for RayStation 1.0.
Dose algorithm accuracy for diverse treatment setups.	The dose algorithm accuracy testing included tests for "treatment setups." All tests were run successfully for RayStation 1.0.
Dose algorithm accuracy for different patient positions.	The dose algorithm accuracy testing included tests for "patient positions." All tests were run successfully for RayStation 1.0.
Dose algorithm accuracy for different dose grid resolutions.	The dose algorithm accuracy testing included tests for "different dose grid resolution settings." All tests were run successfully for RayStation 1.0.
Functional workflow (e.g., import, ROI creation, plan generation).	The detailed workflow steps (import data, define ROIs, create plan, optimize, review, export) imply successful execution and system response as described (e.g., "The system imports the data and checks consistency," "The system adds the ROIs," "The system generates a deliverable step-and-shoot plan"). No quantitative performance metrics are provided.
Device functions as described for treatment planning and analysis.	The device's description and intended use imply that it performs as a treatment planning system producing set-up parameters and dose distributions. The 510(k) clearance indicates the FDA found it substantially equivalent to predicates for this purpose.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "a wide variety of field geometries, treatment units, treatment setups and patient positions, including different dose grid resolution settings" within the dose algorithm accuracy testing. It does not quantify the number of cases or specific configurations tested.
Data Provenance: Not explicitly stated. Given it's a software system for radiation treatment planning, the "data" would likely be simulated or phantom-based data used for dose calculation comparison, rather than patient data in the traditional sense of clinical studies. It's likely software-generated or phantom-measurement driven.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not mentioned. For a dose calculation algorithm, "ground truth" is typically established by physical measurements (e.g., ionization chambers, film dosimetry in phantoms) or highly-validated reference dose calculation algorithms, rather than by expert human consensus on image interpretation. The document does not specify how the "test specification" for dose algorithm accuracy was developed or validated, nor if expert review was part of establishing comparison standards.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 typically refer to human expert disagreement resolution in diagnostic tasks. For software validation (especially a dose calculation engine), "adjudication" would refer to how discrepancies between the software's output and the reference truth were handled, but this is not detailed. The phrase "All tests were run successfully" suggests a pass/fail criterion was met.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC) is typically performed for diagnostic devices where human readers interpret images. RayStation is described as a treatment planning system, where the primary function is to calculate and visualize dose distributions, and assist in planning. There is no mention of a human-in-the-loop diagnostic task where AI improves reader performance.

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

Yes, implicitly. The "dose algorithm accuracy testing" described in section 5.11 is a standalone performance evaluation of the core dose calculation engine. The statement "All tests were run successfully for RayStation 1.0" indicates this standalone algorithm performance met the established (though unspecified) criteria.

7. The Type of Ground Truth Used

The ground truth for the dose algorithm accuracy testing would most likely be established by:

Physical measurements: Using phantoms and dosimetric equipment (e.g., ion chambers, film, diode arrays) to measure actual dose distributions in a controlled environment.
Reference dose calculations: Comparing RayStation's calculated dose to a highly validated, clinically accepted "gold standard" dose calculation engine or analytical solutions for simple geometries.

The document does not explicitly state which method was used, but these are standard practices for validating such systems. It does not refer to expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. RayStation 1.0 is described as a treatment planning system with a dose calculation algorithm (collapsed cone). This type of algorithm is based on physical models of radiation interaction and transport, not typically a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a "training set" for an AI algorithm doesn't directly apply here.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there's no indication of a machine learning-based "training set." If the system incorporated any machine learning components (which is not explicitly stated for RayStation 1.0 in this document, particularly not for its core dose calculation), then the ground truth for that specific component's training would need to be addressed. However, based solely on the provided text, this question is not relevant.

Summary

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K100			ર	ﺎ ﮨﮯ ﮨﮯ ﮨﮯ	ನಿ
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Title:	Document ID:	Version:
510(k) Application - RayStation 1.0	RSL-D-61-04	1.1

510(k) Summary 5.

5.1 510(k) owner

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

MAR 1 2 2010

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

5.2 Contact person

Anders Murman

5.3 Preparation date 12/11/2009

5.4 Trade name

RayStation

RayStation is the product name RaySearch will use introducing this device into the world market. Aliases may be added later, if RayStation is sublicensed to other radiation therapy companies. Throughout the documentation it is our practice to write the trade name and version number together, i.e. "RayStation 1.0".

5.5 Common name

Radiation treatment planning system

રે છે. દિવેલી તેમને છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખે Classification name

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

5.7 Predicate devices

RayAutoplan 1.0	510(k) number K083264
Oncentra MasterPlan 3.1	510(k) number K081281

5.8 Device description

The main workflow, creating a step-and-shoot IMRT plan from an imported patient and case, is described below:

	Flow of Events
	User		System
1.	The user launches RayStation 1.0
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 Treatment
	Specification module and creates a plan

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Title:	Document ID:	Version:
510(k) Application - RayStation 1.0	RSL-D-61-04	1.1

	and a treatment setup with specifiedmachine, treatment energy and deliverytype (SMLC)
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 creates an optimizationproblem
10.	The user defines the algorithm andsegmentation settings and starts theoptimization
			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 Evaluationmodule and evaluates the plan
15.	The user approves and exports the plantogether with dose, structure sets andimages
		16.	The system exports the plan and patientdata to a DICOM server

5.9 Intended use

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.

5.10 Technological characteristics summary

The technological characteristics are the same for RayStation 1.0 as for RayAutoplan 1.0 and Oncentra MasterPlan v3.1. All devices produce IMRT treatment plans with corresponding dose distributions computed using a three dimensional collapsed cone dose engine. All devices have a function of electronic approval of treatment plans by trained and authorized staff, and export in DICOM format for commencing treatment or archiving.

Assessment of non-clinical performance data 5.11

The dose algorithm in both RayStation 1.0 and RayAutoplan 1.0 is the same. This is supported by the dose algorithm accuracy testing, which has used the same test specification 1.0 as was previously used for Ray Autoplan 1.0. The tests include dose calculation for a wide variety of field geometries, treatment units, treatment setups and patient positions, including different dose grid resolution settings. All tests were run successfully for RayStation 1.0.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized lines that resemble a human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAR 1 2 2010

RaySearch Laboratories AB % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747

Re: K100552

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: February 19, 2010 · Received: February 26, 2010

Dear Mr. Conry:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Amelia J. Roth

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K100552

Device Name: RayStation

Indications for Use:

RayStation is a software system designed for treatment planning and analysis of radiation therapy.

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 YES (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 Diagnostic Devices (OIVD)

(Division Sign-Off)

Division Sign-Off)
of Radiological Devices

Office of In Vitro Diagnostic Dev

510K K100552

Page 1 of 1

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.