RayDose is software that computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts.

Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities:

Symmetric and asymmetric rectangular fields
Multileaf collimated fields
Coplanar and non-coplanar fields
Intensity modulated fields using Step-and-shoot technique
Intensity modulated fields using Sliding Window technique

Device Description

RayDose is a software program, which offers dose calculation, either as a separate unit or as a service to other software programs.

In short, RayDose needs the following input:

A patient or phantom description, normally CT images and regions-of-interest
A treatment plan
Settings needed for the dose calculation (such as dose grid and algorithm)

RayDose computes dose to all points in the chosen dose grid, by means of applying the beams of the treatment plan onto the patient or phantom geometry. This dose computation uses the following algorithms:

For fluence, a first principle physics based three-source fluence algorithm exists, where the first source models the collimated primary fluence, the second source models scattered and transmitted fluence from all parts of the treatment head and the third source models electron contributions to the photon fluence.
A collapsed cone algorithm (CC) for calculating bulk doses given impinging fluence exists. This algorithm has a high accuracy also for inhomogeneities in the patient or phantom geometry.

As output, RayDose produces dose values in the chosen dose grid.

The software runs on a Windows XP platform.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a radiation therapy dose calculation engine (RayDose). The acceptance criteria for such a device are intrinsically linked to its accuracy in calculating radiation dose. While explicit numerical acceptance criteria are not presented in a table form, the study's goal is to demonstrate that RayDose's dose calculations are comparable to or within acceptable limits of previously cleared predicate devices (DCM 1.0 and Pinnacle3 Radiation Therapy Planning System). The "reported device performance" is the assertion that RayDose performs similarly to these predicates, implying it meets their inherent accuracy standards.

Acceptance Criterion (Implied)	Reported Device Performance
Dose calculation accuracy for C-shape geometry (inpatient, lung equivalent material)	Within 2% compared to reference calculation or within 2 mm distance-to-agreement
Dose calculation accuracy for breast Tangent geometry (inpatient, lung equivalent material)	Within 2% compared to reference calculation or within 2 mm distance-to-agreement
Dose calculation accuracy for single field dosimetry (phantom)	Within 2% of measurement in homogeneous phantom
Dose calculation accuracy for multileaf collimator (MLC) field dosimetry (phantom)	Within 2% difference or 2mm distance-to-agreement to measurements in homogeneous phantom

2. Sample Size and Data Provenance:

The document states that the testing involved calculations for "a patient" or "phantom description" for dose calculations and "various input data" for linear accelerators. It specifically mentions using a "breast Tangent geometry (in-patient)" and a "C-shape geometry (in-patient)" test cases. Additionally, a "homogeneous phantom" was used for single field and MLC field dosimetry.

Test Set Sample Size: The specific number of patient cases or phantom configurations used for comprehensive validation is not explicitly stated in numerical form but appears to be a small, representative set focused on specific geometries. It mentions "a patient or phantom description" and then later refers to performance for "C-shape geometry" and "breast Tangent geometry." For phantom studies, it mentions "a homogeneous phantom."
Data Provenance: The document does not specify the country of origin for any patient data used. Given that RaySearch Laboratories AB is in Stockholm, Sweden, it is plausible that any patient data, if used, would be from Europe, though this is not confirmed. The clinical use cases mentioned (in-patient lung equivalent material) suggest that the test cases are representative of clinical scenarios. The phantom data is likely generated in a laboratory setting. The nature of the study appears to be entirely retrospective simulation and comparison based on pre-defined geometries and measurements.

3. Number of Experts and their Qualifications:

No human experts were used to establish ground truth for the test set. The validation relies on comparisons to computational reference calculations or physical measurements, not human interpretation.

4. Adjudication Method:

No adjudication method was used for the test set, as the ground truth was established through computational reference or physical measurement, not human consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. RayDose is a dose calculation engine, not a diagnostic or decision-support tool that typically involves human readers. Its performance is evaluated against physical measurements or other calculation algorithms.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The entire document describes the standalone performance of RayDose, where its dose calculations are compared to reference calculations or physical measurements without human intervention in the calculation process. The reported performance metrics (e.g., within 2% or 2mm distance-to-agreement) are direct measurements of the algorithm's accuracy.

7. Type of Ground Truth Used:

The ground truth used for the validation appears to be a combination of:

Computational Reference: For the inpatient C-shape and breast Tangent geometries, the ground truth was established by comparison to a "reference calculation" (from a predicate device or a gold-standard calculation method, though not explicitly detailed as to which specific method).
Physical Measurements: For single field and multileaf collimator (MLC) field dosimetry in a homogeneous phantom, the ground truth was established by "measurements." This typically refers to dosimetric measurements (e.g., using ion chambers or film) in a controlled phantom setup.

8. Sample Size for the Training Set:

The document does not provide information on a specific training set size. Radiation dose calculation engines like RayDose are typically developed using physics-based models and algorithms (e.g., collapsed cone algorithm, three-source fluence algorithm), rather than being "trained" on a large dataset of patient images in the way deep learning models are. The algorithms are derived from physical principles and validated against known physical behaviors and measurements.

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

As mentioned above, RayDose's algorithms are not typically "trained" on a dataset with a conventional "ground truth" in the machine learning sense. Instead, the algorithms are developed based on established physics principles of radiation transport and interaction with matter. The parameters within these physics models are refined and validated against fundamental physical measurements and benchmarks to ensure accuracy across various conditions. Therefore, the "ground truth" for developing the underlying algorithms would be derived from:

Physical Laws and Equations: The foundational principles of radiation physics.
Experimental Data: Measurements from various radiation experiments to characterize beam properties, scattering, and dose deposition in different media.
Monte Carlo Simulations: Often used as highly accurate "gold standard" computational models to verify and refine analytical dose calculation algorithms.

Summary

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KOS2221 0.10+2

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Title:	Document ID:	version:
15100k)Application - RayDose	13 Q-1)-54-30

5. 510(k) Summary RayDose

5.1 510(k) owner

RaySearch Laboratories AB Sveavägen 25, plan 9 111 34 Stockholm Sweden Tel: +46 (8) 54506130 +46 (8) 24506139 Fax:

OCT 2 2 2008

5.2 Contact person

Anders Murman

5.3 Preparation date

03/29/2007

5.4 Trade name

RayDose

5.5 Common name

Radiation therapy dose calculation engine

5.6 Classification name

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

5.7 Predicate devices

DCM 1.0	510(k) number K011246
Pinnacle3 Radiation Therapy Planning System	510(k) number K041577

5.8 Device description

RayDose is a software program, which offers dose calculation, either as a separate unit or as a service to other software programs.

In short, RayDose needs the following input:

A patient or phantom description, normally CT images and regions-of-interest 0
A treatment plan 0
Settings needed for the dose calculation (such as dose grid and algorithm) 0

For fluence, a first principle physics based three-source fluence algorithm exists, where the first 0 source models the collimated primary fluence, the second source models scattered and transmitted fluence from all parts of the treatment head and the third source models electron contributions to the photon fluence.
A collapsed cone algorithm (CC) for calculating bulk doses given impinging fluence exists. This 0 algorithm has a high accuracy also for inhomogeneities in the patient or phantom geometry.

As output, RayDose produces dose values in the chosen dose grid.

The software runs on a Windows XP platform.

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510(k)Application - RayDose	RSL-D-54-30

5.9 Intended use

RayDose is software that computes dose (energy per volume deposited by ionizing radiation) threedimensionally in a geometrical representation of a patient or a phantom, stemming from an external beam treatment unit in a radiation oncology clinic. The computed dose is intended to be used for clinical decisions on planned treatments or in quality assurance contexts.

Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities:

0 Symmetric and asymmetric rectangular fields
Multileaf collimated fields 0
Coplanar and non-coplanar fields 0
Intensity modulated fields using Step-and-shoot technique 0
0 Intensity modulated fields using Sliding Window technique

5.10 Technological characteristics summary

The technological characteristics are the same for RayDose as for DCM 1.0 and Pinnacle3 Radiation Therapy Planning System. All three devices compute fluence for external photon beams using a physicsbased algorithm modeling both the primary and scatter fluence and electron contributions. All three devices compute dose in three dimensions from the fluence using a collapsed cone algorithm.

DCM 1.0 and RayDose support symmetric and asymmetric fields, multileaf collimators, coplanar and noncoplanar fields and intensity modulated step-and-shoot fields.

Pinnacle Radiation Therapy Planning System and RayDose support intensity modulated sliding window fields, also known as dynamic multileaf collimated fields.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2008

RaySearch Laboratories AB % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K082221

Trade/Device Name: RayDose Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: П Product Code: MUJ Dated: October 3. 2008 Received: October 7, 2008

Dear Mr. Lehtonen:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2

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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jorque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

510(k) Number (if known): - Ko82221

Device Name: RayDose 1.0

Indications For Use:

Based on various input data, RayDose is used to compute dose for linear accelerators with X-ray energies from 6 to 18 MV, supporting the following collimation and modulation modalities:

Symmetric and asymmetric rectangular fields O
Multileaf collimated fields 0
Coplanar and non-coplanar fields O
Intensity modulated fields using Step-and-shoot technique O
0 Intensity modulated fields using Sliding Window technique

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use NO (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Leuner

Division of Reproductive, Abdomi Radiological Devices 510(k) 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.