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) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machinespecific data and are intended to provide a quide 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 intracavitary sources (Brachytherapy) are not supported.

Device Description

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) 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 intracavitary sources (Brachytherapy) are not supported.

The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currentlymarketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NOMOS CORVUS 5.0M System, which is a Radiation Therapy Treatment Planning System. The core of this submission is a modification to the operating system from NextStep to Macintosh OS X (Mac OSX), with the claim that this change did not modify the intended use or fundamental scientific technology, and that testing demonstrates clinically equivalent results.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the modification to the CORVUS system (changing the operating system) did not modify the intended use, fundamental scientific technology, or performance specifications. Therefore, the "acceptance criteria" are implicitly that the new system performs at least equivalently to the predicate device (the currently marketed CORVUS System) and adheres to its existing performance specifications.

Performance Characteristic/Acceptance Criteria	Reported Device Performance (CORVUS 5.0M System)
Intended Use	Unchanged from predicate device. Still a radiation treatment planning package for creating conformal plans using photon (x-ray) external beam radiation therapy, guiding delivery to the target volume.
Fundamental Scientific Technology	Unchanged from predicate device.
Performance Specifications	Same as the currently-marketed CORVUS System.
Clinical Equivalence	"Testing performed demonstrates that the modified device produces clinically equivalent results." This implies that the output of the new system (treatment plans) is medically indistinguishable from the output of the predicate device.
Safety and Efficacy	Hazard analysis and testing determined that the modification "does not raise any new issues of safety or efficacy for the device."

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It generally refers to "testing performed" and "hazard analysis and testing" without providing specific details about the dataset or methodology.

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

The document does not specify the number of experts used or their qualifications to establish ground truth for any testing. Given the nature of the device (a treatment planning system), expert review would typically involve medical physicists and radiation oncologists, but this is not explicitly mentioned.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is not a diagnostic device where human readers interpret images, but rather a treatment planning software. The focus is on the equivalence of the software's output to the previous version, not on human interpretive improvement.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

Yes, a standalone performance study was implicitly done. The "testing performed" to demonstrate clinical equivalence would involve comparing the output of the CORVUS 5.0M (algorithm only on the new OS) against the output of the predicate CORVUS system (algorithm only on the old OS). The claim is that the device itself, functioning on the new OS, produces equivalent results. There is no mention of a "human-in-the-loop" component to this specific performance evaluation, as the change is at the operating system level, not the core algorithms or user interaction for treatment planning.

7. Type of Ground Truth Used

The "ground truth" in this context is the performance of the predicate CORVUS System. The new CORVUS 5.0M System's performance was compared against the established, accepted performance of the previous version. This is a case of device-to-device equivalence, where the "truth" is what the previously cleared device produces, and the goal is to show the modified device produces the same "truth." This would involve comparing the treatment plans (e.g., dose distributions, conformality indices, etc.) generated by both systems for the same input data.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models. This device is a treatment planning system based on algorithms, not a machine learning model that undergoes a training phase with a dataset. The system uses "treatment machine-specific data" for its calculations, which is more akin to calibration data for physics models than a training set for an AI.

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

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device's calculations are based on "treatment machine-specific data," which would be established through appropriate calibration and commissioning procedures for the radiation therapy machines it interfaces with.

Summary

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AUG 2 1 2003

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Section 2 - 510(k) Summary

Summary of Safety and Effectiveness NOMOS Motorized CRANE® II

Pursuant to Section 513(i) of the Federal Food, Drug, and Cosmetic Act

A. General Information:

Classification Name:	Medical charged-particle radiation therapysystem accessory: Treatment PlanningSystem(Sec. 892.5050)
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Common/Usual Name: Radiation Therapy Treatment Planning System

Trade/Proprietary Name: CORVUS® 5.0M System

Applicant's Name and Address: Francis X. Dobscha Director of Quality

NOMOS Corporation 200 West Kensinger Drive Cranberry Township, PA 16066

Phone:	724-741-8242
FAX:	724-741-0778
Email:	fdobscha@nomos.com

B. Name of predicate device: NOMOS CORVUS System (K940663, K963258, K972451)
Class II C. Classification:
None established D. Performance Standards:

E. Intended Use and Device Description:

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K03209
page 208

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 intracavitary sources (Brachytherapy) are not supported.

F. Summary of Substantial Equivalence

Indications for Use:

The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.

Materials:

The materials used in the CORVUS 5.0M are equivalent to those used in the currently marketed device. The only difference is the use of computer hardware and peripherals supporting the Mac OSX operating system (versus hardware supporting the NextStep operating system).

Manufacturing:

The manufacturing processes used in the production of the CORVUS 5.0M System has not changed from that used to produce the currently-marketed predicate device. The device is manufactured at the same facility under the same process controls.

Specifications and Fundamental Scientific Technology:

The performance specifications of the CORVUS 5.0M System are the same as the currently-marketed CORVUS System. The design and the fundamental scientific technology upon which the CORVUS System operates have not changed.

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Design Controls:

The modification to the CORVUS System were developed, tested, and implemented following NOMOS Corporation's established processes for design control. NOMOS Corporation's design control processes conform to all applicable requlatory and industry requirements. A hazard analysis and testing were performed to assess the impact of the modification, which resulted in a determination that the modification does not raise any new issues of safety or efficacy for the device.

Conclusions:

Based on the above information, and on NOMOS Corporation's commitment to provide safe, reliable, and effective products, NOMOS considers the CORVUS 5.0M Radiation Therapy Planning System to be substantially equivalent to the currently-marketed CORVUS System.

Note:

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be legally marketed according to FDA regulations and is not relevant evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. (1977).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Ms. Francis X. Dobscha VP, Quality and Regulatory Affairs NOMOS Corporation 200 West Kensinger Drive CRANBERRY TOWNSHIP PA 16066 Re: K032209

Trade/Device Name: CORVUS Radiation Therapy Planning System · Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: July 14, 2003 Received: July 22, 2003

Dear Ms. Dobscha:

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 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); 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.

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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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: Not Assigned

K032209

Page 1 of 1

CORVUS® 5.0M Radiation Therapy Planning System Device Name:

Indications for Use:

The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.

The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The Counter Use
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Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K032209
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000003

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.