ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY

• K Number: K033339
• Device Name: ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
• Manufacturer: VARIAN MEDICAL SYSTEMS, INC.
• Date Cleared: 2003-12-30 ( 74 days)
• Product Code: KPQ , KPR
• Regulation Number: 892.5840
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K023052 , K981056
• Predicate For: N/A

Intended Use

The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.

Device Description

Acuity with ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D multislice planning data in patient set-ups where conventional (Computerized Tomography) CT imaging is not possible. CBCT is a new feature to the Varian Medical Systems Radiation Therapy Simulator, "Acuity" (K023052), and acquires CT slice information as digital images from the Acuity simulator. The images can be viewed and manipulated directly on a computer screen and placed into the Vision Image database for the purpose of radiation therapy treatment planning and patient positioning. CBCT provides Acuity the capability of acquiring and reconstructing 15-17cm of volumetric data in one gantry rotation. This represents approximately 340 0.5mm slices. Acuity combines conventional and CT simulation into one product. Acuity can change from radiographic and fluoroscopic mode for isocenter localization to CT acquisition mode for treatment planning. This is accomplished with no movement of the patient from the actual treatment position.

AI/ML Overview

The provided text describes the Acuity with Conebeam Computed Tomography (CBCT) device and its regulatory clearance, but it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in a typical AI/medical device performance study format.

Instead, the document focuses on regulatory compliance based on existing performance standards for medical devices and a comparison to predicate devices.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (General): The document states that the device was tested in accordance with "21 CFR §1020 - Performance standards for ionizing radiation emitting products. Specifically §1020.30 - Diagnostic x-ray systems and their major components and §1020.33 - Computed tomography (CT) equipment."

• Reported Device Performance: "The results of the tests demonstrated that the Acuity CBCT met the performance standards requirements."

  Note: This is a very high-level statement. It does not provide specific metrics (e.g., spatial resolution, contrast resolution, dose, etc.) or quantitative results against which acceptance criteria would typically be measured in a detailed performance study. It's a statement of compliance rather than a report of specific technical performance values.

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

• Not provided. The document does not mention any specific test sets of patient data, their sample size, or their provenance (country of origin, retrospective/prospective). This is because the performance evaluation cited refers to compliance with general regulatory standards for X-ray and CT equipment, not a study evaluating performance on a dataset of clinical cases.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/Not provided. Since there's no mention of a clinical or image-based test set with ground truth, there's no information about experts establishing that ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. (See point 3)

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document does not describe an MRMC study. The device, an imaging system, would typically have its technical performance (image quality, dose) evaluated, and its clinical utility would be demonstrated by enabling certain procedures (treatment planning, patient positioning), rather than by measuring human reader improvement with an AI algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable/Not provided. The Acuity with CBCT is a medical imaging device, not an AI algorithm. Performance evaluation for such devices focuses on the technical specifications of the imaging system itself.

7. Type of Ground Truth Used

• Not applicable/Not provided in the context of clinical data. For an imaging device, "ground truth" often relates to physical measurements or phantoms used to assess image quality parameters (e.g., known physical dimensions, contrast differences in a phantom). The document broadly states compliance with general CT equipment standards, which would implicitly involve such physical measurements but does not detail them.

8. Sample Size for the Training Set

• Not applicable/Not provided. This device is an imaging system, not an AI/ML algorithm that requires a training set.

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

• Not applicable/Not provided. (See point 8)

Summary of what's present in the document:

The document is a 510(k) summary for a medical device (an X-ray system with Conebeam CT capability). It focuses on:

• Device identification and submitter information.
• Intended use (radiation therapy simulation, acquiring 3D planning data).
• Substantial equivalence to predicate devices (Acuity Radiation Therapy Simulator K023052 and Ximatron Scanvision K981056).
• A statement of compliance with general performance standards for diagnostic X-ray systems and CT equipment (21 CFR §1020.30 and §1020.33). This compliance is the "proof" mentioned in the context of the document, but it's a regulatory "proof" rather than a detailed performance study as one might expect for an AI device.

In conclusion, the document provides evidence of regulatory compliance with existing performance standards for medical imaging equipment, but it does not present a detailed performance study with specific acceptance criteria and results in the format commonly associated with evaluating AI/ML-based medical devices or even a detailed clinical efficacy study.

Summary

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DEC 3 0 2003

Image /page/0/Picture/1 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a bold, sans-serif font, with a stylized "i" that resembles a medical symbol. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font.

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 115A tel [phone] www.varian.com

510(k) Summary
$K033339$ P.142

The following information is provided following the format of 21 CFR 807.92 for the Acuity with Conebeam Computed Tomography

1. Submitter:

Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] Fax: [phone] Email: [e-mail] Date summary was prepared: October 16, 2003

• 2. Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
     Acuity with Conebeam Computed Tomography Acuity with Conebeam Computed Tomography Acuity CBCT Stationary x-ray system 21 CFR §892.1680 Class II Product Code: KPR

3. Predicate Devices to claim substantial equivalence:

• a. Acuity Radiation Therapy Simulator, K023052
• b. Ximatron Scanvision, K981056
• 4. Description of the Device: Acuity with ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D multislice planning data in patient set-ups where conventional (Computerized Tomography) CT imaging is not possible. CBCT is a new feature to the Varian Medical Systems Radiation Therapy Simulator, "Acuity" (K023052), and acquires CT slice information as digital images from the Acuity simulator. The images can be viewed and manipulated directly on a computer screen and placed into the Vision Image database for the purpose of radiation therapy treatment planning and patient positioning. CBCT provides Acuity the capability of acquiring and reconstructing 15-17cm of volumetric data in one gantry rotation. This represents approximately 340 0.5mm slices. Acuity combines conventional and CT simulation into one product. Acuity can change from radiographic and fluoroscopic mode for isocenter localization to CT acquisition mode for treatment planning. This is accomplished with no movement of the patient from the actual treatment position.

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• 5. Intended Use Statement: The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.
• 6. Summary of the Technological Characteristics: the Acuity Radiation Therapy Simulator, K023052 has been modified to include Conebeam Computerized Tomography as a new feature. This new feature will allow the Acuity Radiation Therapy Simulator to acquire 3D multi-slice planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning which is substantially equivalent to the Varian Medical Systems Scanvision device, K981056. The substantial equivalence comparison chart provides a comparison of the technological charactcristics to those of the predicate devices. The chart is located in Tab G.
• 7. Performance Standards Acuity with Conebeam Computed Tomography was tested in accordance with 21 CFR&1020 - Performance standards for ionizing radiation emitting products. Specifically §1020.30 - Diagnostic x-ray systems and their major components and §1020.33 - Computed tomography (CT) equipment. The results of the tests demonstrated that the Acuity CBCT met the performance standards requirements.

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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 consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2003

Mr. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K033339

Trade/Device Name: Acuity with ConeBeam Computerized Tomography Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPO Dated: October 16, 2003 Received: October 17, 2003

Dear Mr. Tran:

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.

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 that I Driner I 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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

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

Enclosure

Page 2

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510(k) Number (if known): Device Name: Acuity with Conebeam Computed Tomography

Indications For Use:

The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use

Daniel A. Leppanen
(Division Sign-Off)

Division of Reproductive, Abdon and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.