RADIANCE by GMV AEROSPACE AND DEFENCE S.A.

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 radiance shall be clinically qualified radiation therapy staff trained in using the system.

Device Description

radiance is a treatment planning system, that is, 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 alternative plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.

AI/ML Overview

The provided text describes GMV Aerospace and Defence S.A.'s "radiance" device, a radiation treatment planning software, and its 510(k) premarket notification. The submission focuses on establishing substantial equivalence to a predicate device, RayStation (K100552). However, the document does not contain explicit acceptance criteria or details of a study designed to prove the device meets specific performance criteria.

Instead, the submission relies on demonstrating substantial equivalence to an already cleared device. This means the primary "proof" is the argument that radiance is technologically similar to the predicate and raises no new questions of safety or effectiveness.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
None explicitly stated in the document.	Not applicable, as no explicit criteria are provided.
Implicit Acceptance Criteria (from Substantial Equivalence):
Technological Characteristics are essentially the same as predicates.	"The technological characteristics are essentially the same as those of the predicate. All devices produce treatment plans with corresponding dose distributions computed using a three dimensional dosimetry 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."
No new types of questions about safety or effectiveness compared to the predicate.	"The submitted devices pose the same types of questions about safety or effectiveness as the existing device."
Device functions as a treatment planning system for intraoperative radiation therapy via electron beams, providing treatment unit set-up parameters and dose distribution estimates.	This is the stated "Intended Use" of the radiance device, aligning with its role as a treatment planning system.
Dose calculations use a three-dimensional dose engine.	"Dose distributions computed using a three dimensional dose engine."
Input is externally acquired patient medical images and user input.	"Externally acquired patient medical images and user input."
Output is treatment plans with corresponding dose distributions.	"Treatment plans with corresponding dose distributions."
Allows electronic approval of treatment plans by trained and authorized staff.	"Allows electronic approval of treatment plans by trained and authorized staff."
Dose calculation algorithms are confirmed for a wide variety of field geometries, treatment units, treatment setups, and patient positions, including different dose grid resolution settings.	This is listed under "Dose calculation algorithm confirmation" for radiance.

Missing Information: The document does not provide quantitative performance metrics (e.g., accuracy, precision, specific tolerances for dose calculation). This is typical for a 510(k) submission based on substantial equivalence, where detailed performance studies might not be required if the device is demonstrated to be equivalent to an already cleared device.

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

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned. The submission focuses on device comparison rather than clinical data.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned.

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

MRMC Study Done: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The radiance device is a treatment planning software, not an AI diagnostic aid that would typically involve human reader performance comparisons in this context.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was performed or discussed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A formal "standalone" study in the sense of a diagnostic algorithm's performance independent of human interpretation is not described. However, the document does state that the device's "Dose calculation algorithm confirmation" was performed for various parameters. This implies an internal validation of the algorithm's output (dose distributions) against expected values or established benchmarks, but the details of this validation are not provided. The study is largely a comparison of features to a predicate.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For "Dose calculation algorithm confirmation," it would typically involve comparisons against established physics models, phantom measurements, or existing verified treatment planning systems. The document doesn't specify if clinical outcomes or pathology reports were used to validate the treatment plans produced by radiance.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. As a treatment planning system based on physics models and algorithms, there isn't a "training set" in the machine learning sense. The device's underlying algorithms are developed based on physical principles, not trained on a dataset.

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

How Ground Truth for Training Set was Established: Not applicable, for the reasons stated above. The ground truth for the underlying physics models and algorithms would be established through decades of radiation physics research and experimental validation.

Summary

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radiance Premarket Notification: Traditional 510(k)

510(k) Summary

Submitter Name:	GMV Aerospace and Defence S.A.
Submitter Address:	Isaac Newton, 11; PTM Tres CantosMadrid 28760Spain
Phone Number:	011 34 91 807 22 70
Fax Number:	011 34 91 807 21 99
Contact Person:	Carlos Illana Alejandro
Date Prepared:	15 July 2011
Device Trade Name:	radiance
Common Name	Radiation Treatment Planning Software
Classification Name,Number &Product Code:	Medical charged-particle radiation therapy system21 CFR 892.5050MUJ
Predicate Devices:	RayStation K100552 cleared 12 March 2010
Device Descriptionand Statement ofIntended Use	radiance is a treatment planning system, that is, a softwareprogram for planning and analysis of radiation therapy plans.Typically, a treatment plan is created by importing patient imagesobtained from a CT scanner, defining regions of interest eithermanually or semi-automatically, deciding on a treatment setup andobjectives, optimizing the treatment parameters, comparingalternative plans to find the best compromise, computing theclinical dose distribution, approving the plan and exporting it.
	Statement of Intended Use:
	radiance is a software system intended for treatment planning andanalysis of intraoperative radiation therapy by means of electronbeams.
	The treatment plans provide treatment unit set-up parameters andestimates of dose distributions expected during the proposed

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Summary ofTechnologicalCharacteristics	The technological characteristics are essentially the same as thoseof the predicate.All devices produce treatment plans with corresponding dosedistributions computed using a three dimensional dosimetryengine. All devices have a function of electronic approval oftreatment plans by trained and authorized staff, and export inDICOM format for commencing treatment or archiving.
SubstantialEquivalence	The radiance device is substantially equivalent to the RayStation(K100552), with respect to technical and design features. Thesubmitted devices pose the same types of questions about safety oreffectiveness as the existing device.
Conclusion	The information discussed above demonstrates that the radiancedevice is substantially equivalent to the predicate device.
Declarations	This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. This summary does not contain any patient identification information.

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Feature	Device radiance	RayStation	Eclipse	NOVAC7
510(k)Number		K100552	K102011	K990209
Manufacturer	GMV Aerospaceand Defence S.A.	RaySearchLaboratories AB	Varian MedicalSystems, Inc.	HITESYS S.P.A.
Classification# & ProductCode	21 CFR 892.5050MUJ	21 CFR 892.5050MUJ	21 CFR 892.5050MUJ	21 CFR 892.5050IYE
Intended Use	radiance is asoftware systemintended fortreatmentplanning andanalysis ofintraoperativeradiation therapyby means ofelectron beams.The treatmentplans providetreatment unitset-up parametersand estimates ofdose distributionsexpected duringthe proposedtreatment, andmay be used toadministertreatments afterreview andapproval by theintended user.The systemfunctionality canbe configuredbased on userneeds.The intendedusers of radianceshall be clinically	RayStation is asoftware systemdesigned fortreatmentplanning andanalysis ofradiation therapy.The treatmentplans providetreatment unitset-up parametersand estimates ofdose distributionsexpected duringthe proposedtreatment, andmay be used toadministertreatments afterreview andapproval by theintended user.The systemfunctionality canbe configuredbased on userneeds.The intendedusers ofRayStation shallbe clinicallyqualifiedradiation therapy	The EclipseTreatmentPlanning System(Eclipse TPS) isused to planradiotherapytreatments forpatients withmalignant orbenign diseases.Eclipse TPS isused to planexternal beamirradiation withphoton, electronand protonbeams, as well asfor internalirradiation(brachytherapy)treatments. Inaddition, theEclipse ProtonEye algorithm isspecificallyindicated forplanning protontreatment ofneoplasms of theeye.	The NOVAC7 isan electron linearaccelerator usedfor radiationtherapy duringsurgicalprocedures in anoperating roomfor the treatmentof malignant andbenign conditions.Know asintraoperativeradiation therapy(IORT), thistechnique allowsdelivery of highdoses of radiationdirectly aimed attumors or othersites whileavoiding dosageto surgicallymobilized normaltissues.The NOVAC7 is amobile andarticulatedmachine that canbe moved towardsthe patient and putin the appropriateposition to carryout the necessaryradiotherapy.Applicators directthe electron beamto the surgical areaof interest
	qualifiedradiation therapystaff trained inusing the system.	staff trained inusing thesystem.
SystemDesign	Software only	Same	Software only	Hardware andSoftware
Calculation	Dosedistributionscomputed using athree dimensionaldose engine.	Same	Same forelectrons	Same for MUcomputation
Input	Externallyacquired patientmedical imagesand user input	Same	Same	Same for MU:MU/Gy factor +additional factors
Output	Treatment planswithcorrespondingdose distributions	Same	Same forelectrons	Monitor units
Plan reviewand approval	Allows electronicapproval oftreatment plansby trained andauthorized staff	Same	Same	None
Dosecalculationalgorithmconfirmation	Algorithmsconfirmed for awide variety offield geometries,treatment units,treatment setupsand patientpositions,includingdifferent dosegrid resolutionsettings.		Same forelectrons	Same for MUcomputation

Summary of Technical Characteristics

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Document Control Room - WO
JAN - 6 2012

GMV Aerospace and Defence S.A. % Mr. William F. Greenrose Official Correspondant and Regulatory Consultant for GMV Aerospace and Defence S.A. Oserve America. Inc. 220 River Road CLAREMONT NH 03743-5647

· Re: K112060

Trade/Device Name: radiance Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: December 8, 2011 Received: December 13, 2011

Dear Mr. Greenrose:

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 requirences as be ferm mrketing your device as described in your Section 510(k) premarket will anow you to begin mainening your intilal equivalence of your device to a legally marketed nonthoution. The I Driven 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 11 you desire specific at res see you Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Theos, promotions of the mart 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 Tou may obtain other generational 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,

Mary S Patel

Mary S. Pastel. Sc.D. 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

K112060 510(k) Number (if known):

radiance Device Name:

Indications For Use:

radiance is a software system intended for treatment planning and analysis of intraoperative radiation therapy by means of electron beams.

The system functionality can be configured based on user needs.

The intended users of radiance 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 Device Evaluation (ODE)

Marn Pastil

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Office of In Vitro Diag

510K. K112060

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.