The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.

Device Description

CORVUS is a semi-automatic planning system: For forward planning, the system allows the user to design a treatment plan. For IMRT, rather than simply verifying a user-designed plan, the system itself suggests a plan. A clinician then reviews and approves the plan.

CORVUS is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. The treatment beams are weighted so that when they are projected into the treatment space they superimpose to give the desired dose distribution.

Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent.

The treatment beams are set not only to deliver the prescribed dose to the identified target volume, but also to keep the dose to other sensitive volumes below user-defined limits. Planning is done volumetrically: the beam weights for treating the entire target volume are generated simultaneously. The dose matrix is volumetric. The dose to each point is calculated to be that received from all beams and from all gantry angles. Dosage is calculated using a finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data. The degree to which a treatment plan is optimized is determined in part by constraints placed on the planning algorithm. The user has direct control over these constraints, which include dose goals to the target structures, dose limits to the sensitive structures, and the specification of arcs or fixed gantry positions in the treatment plan.

CORVUS treatment plans need not have the isocenter located within the target volume. An unlimited number of targets falling within the treatment volume can be planned for at the same time. Dose may be prescribed for up to 32 structures, 29 of them user-selectable, any number of which may be separate targets or radiation-sensitive structures. Each structure can have a separate dose prescription.

AI/ML Overview

The CORVUS system is a radiation treatment planning package. The provided text, which appears to be an FDA 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device (CORVUS 2011, K151469) rather than detailing specific acceptance criteria and a study proving device performance against those criteria in a typical clinical performance study format.

However, based on the Summary of Testing section (L), we can infer how performance was assessed for the purpose of demonstrating substantial equivalence.

Here's an attempt to structure the information according to your request, extracting what's available and noting what is not explicitly stated in the provided text.

Acceptance Criteria and Device Performance Study for CORVUS (K201350)

The provided document, an FDA 510(k) summary, describes the CORVUS system as a radiation treatment planning package. The core purpose of this submission is to demonstrate substantial equivalence to a predicate device (CORVUS 2011, K151469). Therefore, the "acceptance criteria" and "study" described herein are primarily focused on design verification and validation tests to ensure the new device functions as intended, mitigates risks, and is equivalent to its predicate.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Since explicit, quantifiable acceptance criteria with corresponding performance metrics are not presented in a direct table in this document, they are inferred from the verification and validation (V&V) activities described. The reported performance is generally stated as meeting requirements and demonstrating substantial equivalence.

Acceptance Criteria Category (Inferred)	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Functional & System Performance	Device functionality works as per its intended use.	Met design requirements and specifications through system tests and run-through integration tests.
Risk Mitigation & Safety	All risks are mitigated; raises no new issues of safety or effectiveness compared to the predicate.	Documented through "Summary of Testing" and "Comparison to Predicate Device" sections; stated that "no new issues of safety or effectiveness" are raised. Anomaly verification was performed.
Clinical Workflow & Usability	Usability is appropriate for medical physicists, dosimetrists, and radiation oncologists.	Demonstrated through clinical workflow and treatment planning software usability validation activities. Conforms to IEC 62366-1.
Clinical Plan Quality & Optimization	Produces conformal treatment plans that help achieve target goals while sparing sensitive structures, similar to predicate.	Evaluated through clinical plan quality/optimization comparison. Results were deemed satisfactory to demonstrate substantial equivalence.
Dosimetric Accuracy	Dose calculations are accurate, particularly for Cobalt-60 based treatment planning (new feature) and X-ray.	Verified through comparison with medical physics measurements, including film and ion chamber measurements. The pencil-beam algorithm and homogeneous/EPL options (and LDI for X-ray) are consistent with the predicate.
Substantial Equivalence	Device is substantially equivalent to predicate device CORVUS 2011 (K151469).	"The verification and validation results demonstrate that the CORVUS 14 system... is substantially equivalent to its predicate device." The key difference, Cobalt-60 support, was tested and deemed not to raise new safety/effectiveness concerns.
MDR & Regulatory Compliance	Conforms to applicable standards (IEC 62304, IEC 62366-1, IEC 61217, IEC 62083). Software level of concern: "Major".	Demonstrated compliance with all listed IEC standards.

2. Sample Sizes and Data Provenance for Test Set

The document does not explicitly state the sample size (e.g., number of patient cases, treatment plans) used for the "test set" in the context of clinical plan quality, optimization, or dosimetric accuracy.

Sample Size: Not explicitly stated. The document refers to "comparison with medical physics measurements including film and ion chamber measurements" and "clinical plan quality / optimization comparison," implying multiple cases or scenarios were tested.
Data Provenance: Not explicitly stated. It is typical for such V&V studies to use a combination of simulated data, phantom data, and potentially de-identified clinical data. Given the "medical physics measurements" and "clinical plan quality" evaluations, it's likely that phantom data and potentially retrospective clinical cases were used, but the document does not specify country of origin or whether data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "medical physicists, dosimetrists, and radiation oncologists" as users of the system and participants in activities like "clinical workflow" and "clinical plan quality / optimization comparison." However, it does not specify:

Number of Experts: Not explicitly stated.
Qualifications of Experts: It implies that these are qualified professionals (e.g., medical physicists, radiation oncologists) who would typically have extensive experience in radiation therapy planning and delivery. Specific years of experience are not mentioned. Their role would be to evaluate the usability and clinical appropriateness of the plans generated by CORVUS, likely against established clinical best practices or phantom measurements used as ground truth.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for evaluating a test set. The validation activities included "clinical workflow, treatment planning software usability, clinical plan quality / optimization comparison, and dosimetric accuracy," which suggest evaluations were performed by qualified personnel. However, the process for resolving disagreements or establishing a consensus "ground truth" among multiple reviewers is not detailed.

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

Was it done? No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI vs. without AI assistance. The CORVUS system is a treatment planning tool for physicists, dosimetrists, and oncologists, not an AI-assisted diagnostic or interpretation system for human readers in the traditional sense of an MRMC study. Its function is to generate plans, which are then reviewed and approved by clinicians.
Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone Performance Study

Was it done? Yes, a standalone performance assessment akin to an "algorithm only" evaluation was performed. The "dosimetric accuracy" assessment ("comparison with medical physics measurements including film and ion chamber measurements") and "clinical plan quality / optimization comparison" directly evaluate the output of the algorithm in generating treatment plans and calculating doses. This inherently assesses the software's performance independent of real-time human interaction during plan generation, although human experts certainly reviewed and evaluated these outputs.

7. Type of Ground Truth Used

The ground truth for evaluating the CORVUS system's performance appears to be a combination of:

Medical Physics Measurements: "Film and ion chamber measurements" served as the ground truth for dosimetric accuracy. These are standard, highly accurate physical measurements used to verify calculated dose distributions in phantoms.
Clinical Best Practices/Expert Consensus: "Clinical plan quality / optimization comparison" likely relied on assessment against established clinical guidelines, benchmarks, or expert consensus regarding acceptable dose distributions to targets and sensitive structures.

8. Sample Size for the Training Set

The document does not explicitly state a "training set" sample size for the CORVUS system in the context of AI/machine learning. CORVUS is described as a "semi-automatic planning system" using optimization methods like "simulated annealing and gradient descent," and a "finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data."

This description suggests a rules-based system or an optimization engine that may be calibrated with machine-specific data rather than trained on a large dataset of patient cases in the way that contemporary deep learning models are. If "training" refers to the data used to characterize the treatment machines for the FSPB algorithm:

Sample Size: Not specified. This would typically involve a proprietary dataset collected by the manufacturer to model the performance of specific linear accelerators or Cobalt-60 units.

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

Given the nature of the device (a treatment planning system using physics-based algorithms and optimization), the "ground truth" for the calibration/development (if we call it training) of the system's core algorithms (like the FSPB algorithm) would generally be established by:

Physical Measurements: Extensive physical measurements of radiation beam characteristics (e.g., dose profiles, depth doses, output factors) using dosimeters (ion chambers, film, detectors) on phantoms under various geometries and configurations. This "clinically measured data" is used to characterize the treatment machine's behavior, which in turn informs the FSPB algorithm.
Mathematical/Physics Models: The algorithms themselves are based on established physics principles, which serve as foundational "ground truth" for the calculations.

Summary

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September 20, 2020

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Best Nomos % Vineet Gupta, Ph.D. Director - R&D One Best Drive PITTSBURGH PA 15202

Re: K201350

Trade/Device Name: CORVUS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: August 21, 2020 Received: August 24, 2020

Dear Dr. Gupta:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201350

Device Name

CORVUS

Indications for Use (Describe)

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K201350

510(k) Summary

A. SUBMITTERS NAME

Best NOMOS

B. ADDRESS

One Best Drive Pittsburgh, PA 15202

C. CONTACT

Name:	Vineet Gupta, Ph.D.
Phone:	(412) 312-6819
Fax:	(412) 312-6701
Email:	vineet.gupta@nomos.com

D. DATE PREPARED

May 20, 2020

E. DEVICE NAME

Device Trade Name:	CORVUS
Common Name:	Radiation Therapy Treatment Planning System
Classification Name:	Medical charged-particle radiation therapy system(21CFR 892.5050)

F. DEVICE CLASS

Class II Panel: Radiology Product Code: 90-MUJ Regulation Number: 21CFR 892.5050

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One Best Drive (formerly One Conair Drive), Pittsburgh, PA 15202 USA phone 412 312 6700 800 70 NOMOS fax 412 312 6701 www.nomos.com

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G. PREDICATE DEVICES

CORVUS Radiation Therapy Treatment Planning System 2011 (K151469)

H. STATEMENT OF INDICATIONS FOR USE

The intended use for the CORVUS Radiation Therapy Treatment Planning System has been updated to include the support for forward planning based treatment planning. The indications for use for the CORVUS Radiation Therapy Treatment Planning System has not changed due to this modification to the product. This modification does not change the fundamental principle of using photons for creating conformal treatment plans which is the same as that of its predicate device.

Intended Use

CORVUS is intended for use as a planning tool for conformal radiation therapy. For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.

CORVUS is intended only to suggest a delivery plan. It is the physician's responsibility to verify that the dose distributions which would result from plan implementation are appropriate for a particular patient.

The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. CORVUS produces radiation fields to conform to the projected tumor volume plus margins as desired during planning. The system provides statistical calculations to help achieve target goals while sparing sensitive structures.

Indications for Use

The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.

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I. DEVICE DESCRIPTION

Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent.

J. PREDICATE DEVICE INFORMATION

The CORVUS 14 system is substantially equivalent to its primary predicate device CORVUS 2011 (K151469; Decision Date: 25-Nov-2015). The CORVUS 2011 system was determined to be substantially equivalent to its predicate device as of November 2015.

The fundamental scientific technology of the CORVUS 14 with respect to its predicate device (CORVUS 2011) system has not changed. The indications for use of the device has not changed. Based upon the performance testing results for CORVUS 14 (as detailed in the submission), the system raises no new issues of safety or effectiveness.

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K. COMPARISON TO THE PREDICATE DEVICE

This section provides the summary of comparison of CORVUS 14 to the predicate device.

	Proposed Device	Predicate Device
	CORVUS 14	CORVUS 2011 (K151469)
Intended Use	CORVUS is intended for use as aplanning tool for conformal radiationtherapy. For IMRT, using operator-supplied input and patient scans, itcreates a plan for treatment deliverysystems and generates a set of beamweights that, when applied to acompatible system, facilitates deliveryof an intensity-modulated 3Dconformal radiation therapy treatment.For Forward Planning, CORVUS helpsthe user manually create a plan fortreatment delivery based on usersupplied inputs and patient scansincluding dose calculation. ForwardPlanning is supported only for Cobalt-60 based treatment planningCORVUS is intended only to suggest adelivery plan. It is the physician'sresponsibility to verify that the dosedistributions which would result fromplan implementation are appropriatefor a particular patient.The CORVUS system is intended to beused as an integrated system with adelivery device for planning anddelivery of conformal radiationtherapy. CORVUS produces radiationfields to conform to the projectedtumor volume plus margins as desiredduring planning. The system providesstatistical calculations to help achievetarget goals while sparing sensitive	CORVUS is intended for use as aplanning tool for conformal radiationtherapy. Using operator-supplied inputand patient scans, it creates a plan fortreatment delivery systems andgenerates a set of beam weights that,when applied to a compatible system,facilitates delivery of an intensity-modulated 3D conformal radiationtherapy treatment.CORVUS is intended only to suggest adelivery plan. It is the physician'sresponsibility to verify that the dosedistributions which would result fromplan implementation are appropriatefor a particular patient.The CORVUS system is intended to beused as an integrated system with amodulating device for planning anddelivery of conformal radiationtherapy. The modulating device can bethe NOMOS MIMiC, nomosSTATMLC, or a supported MLC. CORVUSproduces radiation fields which aremodulated to conform to the projectedtumor volume plus margins. Thesystem tries to achieve target goalswhile sparing sensitive structures.
Indications forUse	structures.The CORVUS system is a radiationtreatment planning package designed to	The CORVUS system is a radiationtreatment planning package designed to
allow medical physicists, dosimetrists,and radiation oncologists to createconformal treatment plans usingphoton (x-ray, gamma ray) externalbeam radiation therapy. The treatmentplans generated by CORVUS are basedupon treatment machine-specific dataand are intended to provide a guide todelivering external beam radiationtherapy which conforms to the targetvolume defined by the radiationoncologist.The CORVUS system is valid for useonly with external beam photontherapy; calculations for electrons andintracavity sources (Brachytherapy) areNOT supported.	allow medical physicists, dosimetrists,and radiation oncologists to createconformal treatment plans usingphoton (x-ray, gamma ray) externalbeam radiation therapy. The treatmentplans generated by CORVUS are basedupon treatment machine-specific dataand are intended to provide a guide todelivering external beam radiationtherapy which conforms to the targetvolume defined by the radiationoncologist.The CORVUS system is valid for useonly with external beam photontherapy; calculations for electrons andintracavity sources (Brachytherapy) areNOT supported

Table 1 Indications for Use & Intended Use Comparison

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Comparison Item	Proposed DeviceCORVUS 14	Predicate DeviceCORVUS 2011 (K151469)
Product Code	90-MUJ	90-MUJ
Class	II	II
Regulation Number	892.5050	892.5050
Operating System	Mac OS X	Mac OS X
Treatment Planning Support forX-Rays	MLC-IMRT, Serial Tomotherapy(MIMiC-IMRT)	MLC-IMRT, Serial Tomotherapy(MIMiC-IMRT)
Treatment Planning Support forCobalt-60 (Gamma Rays)	Serial Tomotherapy (MIMiC-IMRT),MLC-IMRT, Forward Planning	Serial Tomotherapy (MIMiC-IMRT)

Table 2 General Comparison

CORVUS 14 contains all of the features of CORVUS 2011 (K151469) and adds the feature of supporting Cobalt-60 based external beam radiation treatment planning based on IMRT and Forward Planning. The similarities and differences are discussed in detail as part of this submission.

In both products, CORVUS 14 and CORVUS 2011, the pencil-beam algorithm is used and dose calculation can be performed using either a homogeneous option or an Effective Path Length (EPL) option. The dose calculation based on the Lateral Disequilibrium Inclusive option is only supported for X-Ray based treatment planning in CORVUS 14 as it was in the

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predicate device CORVUS 2011 (K151469). The optimization algorithms used in both products are the same.

The target population and indications for use are similar to that of the predicate devices. In addition, the fundamental technical characteristics are the same as those of the predicate devices and any minor differences in features do not raise any concerns for safety, performance, or effectiveness of the device. The characteristics/features of CORVUS 14 with respect to the predicate device is described in the comparison chart in the submission.

L. SUMMARY OF TESTING

Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, is substantially equivalent, and the product conforms to the required standards. The software for this device is considered as a "Major" level of concern. The details of the design verification and validation activities are explained in the submission as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The verification activities included system tests, anomaly verification, code reviews, and run-though integration tests.

The validation activities included clinical workflow, treatment planning software usability, clinical plan quality / optimization comparison, and dosimetric accuracy. The accuracy of treatment plans was evaluated through comparison with medical physics measurements including film and ion chamber measurements.

Conclusion:

Detailed results of these tests are included as part of this submission. The verification and validation results demonstrate that the CORVUS 14 system met its design requirements and specifications, is substantially equivalent to its predicate device, and conforms to the applicable sections of standards that includes:

. IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
IEC 62366-1 Edition 1.0 2020-06 Application of usability engineering to medical devices ●
IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment Coordinates, movements, and ● scales
. IEC 62083 Edition 2.0 2009-09 Requirements for the safety of radiotherapy treatment planning systems

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.