(30 days)
The Varian ProtonVision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.
The Varian ProtonVision device is used to plan proton radiation therapy treatments employing proton accelerators with energies from 70 to 235 MeV. ProtonVision will plan the 3D radiotherapy proton treatment approaches to rectangle and circular fields, and regular and irregular fields using customized blocking and compensators. ProtonVision includes also tools for treatment preparation (diagnostic image analysis, contouring & segmentation) and plan review.
As part of the Varis Vision System, ProtonVision integrates proton treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
The Varian ProtonVision is a computer based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of proton therapy. The system consists of a computer with graphics display and plotter outp As a Soma Vision (K992751) option, Proton Vision provides the capabilities of diagnostic image analysis, contouring and segmentation. In addition to SomaVision, ProtonVision e and the protone energy range estimation and dose compensation, proton dose calculation and dosimerice plan review. Proton Vision integrates proton treatment planning with
The provided document is a 510(k) Premarket Notification summary for the Varian ProtonVision 7.0 device from August 30, 2000. This type of document is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device.
Unfortunately, the provided text does not contain the detailed information required to fill out the requested table and study characteristics.
Here's why and what's missing:
- No acceptance criteria or device performance metrics are explicitly stated. The document focuses on regulatory compliance (510(k) submission, substantial equivalence) and a general description of the device's function. It does not include performance data such as accuracy, precision, sensitivity, specificity, or any specific quantitative metrics that would be part of an acceptance criterion.
- No specific study details are provided. The document refers to the device being substantially equivalent to its predicate (ProtonVision 7.0, K000922) and lists its intended use and technological characteristics (referencing an attached "Specification Comparison Chart, Tab F," which is not included). A 510(k) submission typically relies on a comparison to a predicate device rather than presenting new, detailed performance studies with sample sizes, ground truth establishment, or expert adjudication.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document does not define specific performance metrics or acceptance criteria for the ProtonVision 7.0. It primarily asserts substantial equivalence to a predicate device (ProtonVision 7.0, K000922), implying that its performance is comparable, but no quantitative performance data is provided.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified. This type of submission (510(k) in 2000) for a software update often did not require extensive new clinical studies or detailed test set information beyond demonstrating functional equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study is not mentioned or implied. The device is a treatment planning system and not an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not specified. Given the device's function as a "treatment planning system" for calculating and displaying plans, its performance is inherently in conjunction with human use (planning by a clinician). Standalone performance in the sense of a diagnostic algorithm is not applicable here.
7. The type of ground truth used
- Not specified. For a treatment planning system, ground truth would typically refer to the accuracy of dose calculations against physical measurements or validated models, or the accuracy of segmentation against expert contours. This level of detail is not in the summary.
8. The sample size for the training set
- Not applicable/Not specified. This device pre-dates modern "AI" in the sense of deep learning or machine learning requiring large training sets. Its functionality is described as "calculating and displaying" based on established physics models and algorithms, not "trained" on data.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See point 8).
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device for a treatment planning system rather than presenting detailed performance studies with quantitative acceptance criteria, test sets, or ground truth establishment typically found for novel diagnostic AI devices.
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AUG 3 0 2000
K002312
Page 1 of 2
Image /page/0/Picture/2 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in bold, uppercase letters. The "I" in "VARIAN" is stylized with a curved top and a dot above it. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font.
alo Alto, CA 94304-1038 +1 650 493 4000 w.varian.com
Premarket Notification [510K] Summary as required by 21 CFR 807.92
Date Summary was prepared; July 26, 2000
Submitter's Name:
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Person: Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance (650) 424-6990 Phone FAX (650) 855-7364 E-Mail linda.nash@os.varian.com
Device Name: ProtonVision 7.0
Classification Name: Medical Charged Particle Radiation Therapy Systems
Predicate Device: ProtonVision 7.0, K000922
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K002312
Page 2 of 2
Product Description:
The Varian ProtonVision is a computer based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of proton therapy. The system consists of a computer with graphics display and plotter outp As a Soma Vision (K992751) option, Proton Vision provides the capabilities of diagnostic image analysis, contouring and segmentation. In addition to SomaVision, ProtonVision e and the protone energy range estimation and dose compensation, proton dose
calculation and dosimerice plan review. Proton Vision integrates proton treatment planning
with
Intended Use:
The Varian Proton Vision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.
Technological Characteristics :
See attached Specification Comparison Chart, Tab F
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2000
Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Varian Medical Systems 3100 Hansen Way M/S E-055 Palo Alto, CA 94304-1129
Re: K002312
Proton Vision 7.0.3 Radiation Therapy Treatment Planning System Dated: July 26, 2000 Received: July 31, 2000 21 CFR §892.5050/Procode: 90 MUJ
Dear Ms. Nash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, aqainst misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Aproval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not ification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnoslic devices), please contact the Office of Compliance at (301) 594-4591. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys a sense of innovation and expertise.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA tel +1 650 493 4000 www.varian.com
Indications For Use
510(k) Number: K 002312
Device Name: ProtonVision 7.0
Indications For Use:
The Varian ProtonVision device is used to plan proton radiation therapy treatments employing proton accelerators with energies from 70 to 235 MeV. ProtonVision will plan the 3D radiotherapy proton treatment approaches to rectangle and circular fields, and regular and irregular fields using customized blocking and compensators. ProtonVision includes also tools for treatment preparation (diagnostic image analysis, contouring & segmentation) and plan review.
As part of the Varis Vision System, ProtonVision integrates proton treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
(PLEASE DØ NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K00231
Prescription Use OR (per 21 CFR 801.109)
Over-The-Counter Use_
§ 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.