(114 days)
The intended use of the ARTÍSTE MV SA™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ACCEL system is the internal name for the Siemens program which includes the ONCOR Linear Accelerator product lines. The newest member of the ACCEL systems is the ARTISTE MV SATM Linear Accelerator product. The ARTÍSTE MV SA™ is composed of upgraded hardware, firmware and software as standard features.
The ARTÍSTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.
The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications.
The provided text describes a 510(k) summary for the Siemens ARTISTE MV SA™ linear accelerator system, which is a therapeutic device for cancer treatment. This type of regulatory submission focuses on substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies for novel AI/software devices. Therefore, much of the requested information about acceptance criteria, study details, and AI performance metrics is not available in the provided document.
However, I can extract information related to the device description and regulatory aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided 510(k) summary. The document does not describe specific performance metrics or acceptance criteria for the ARTISTE MV SA™. Instead, it asserts substantial equivalence to a predicate device based on its intended use and technological characteristics.
2. Sample size used for the test set and the data provenance:
This information is not available. The document does not describe any specific testing with a 'test set' in the context of performance metrics for an AI-like algorithm. The submission is for a linear accelerator, not a diagnostic AI device requiring such testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available. The concept of "ground truth" and expert adjudication is typically applicable to diagnostic imaging AI devices, which is not the primary focus of this linear accelerator submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available. As above, this is relevant for diagnostic AI performance studies, which are not described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not available. The ARTISTE MV SA™ is a treatment delivery system, not a diagnostic AI device that would typically involve human readers. While it includes "MVision™ (Cone Beam acquisition and reconstruction and the Adaptive Targeting application)," the document does not present it as a standalone diagnostic AI for interpretation by human readers requiring an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not explicitly detailed as a separate performance study. The document states that the syngo™ RT Therapist Express Workspace, which includes MVision™, is a software application. However, it does not provide a standalone performance study report for these embedded features in isolation from the overall linear accelerator system's function. The focus is on the device as a whole for therapeutic treatment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/available in the context of the provided 510(k) summary for a linear accelerator. The "ground truth" for a therapeutic device would generally relate to the accuracy of radiation delivery and treatment effectiveness, which are assessed through different means than expert consensus on images.
8. The sample size for the training set:
This information is not available. As a medical device for therapeutic purpose, the submission focuses on hardware and software equivalence, not on AI model training data.
9. How the ground truth for the training set was established:
This information is not available. This concept is relevant for AI model development, which is not the focus of this 510(k) submission.
Summary based on the provided text:
The provided document is a 510(k) summary for a linear accelerator (ARTISTE MV SA™). The purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not to present extensive performance criteria and studies akin to those required for novel AI-powered diagnostic tools. Therefore, the document largely focuses on device description, intended use, and comparison to the predicate device (ONCOR EXPRESSION with COHERENCE Workspaces, K060226) without delving into the detailed performance metrics of specific software algorithms (like MVision™) that would typically involve the requested information. The FDA's letter confirms substantial equivalence, allowing the device to proceed to market under general controls.
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SIEMENS
2007
Section 5 510(k) Summary and Statement
| Submitter: | Siemens Medical Solutions USA, Inc., Oncology Care Systems | |
|---|---|---|
| Address: | 4040 Nelson Ave.Concord, CA 94520USA | |
| Phone number: | 925-246-8378 | |
| Fax number: | 925-602-8008 | |
| Contact person: | Bill Collins, Manager, Regulatory Affairs | |
| Date prepared: | 8/31/2007 | DEC 2 7 |
| Trade name: | ARTÍSTE MV SATM | |
| Device classification: | 892.5050/ IYE/Radiology | |
| Substantial equivalence claimed to: | ONCOR EXPRESSION with COHERENCE Workspaces (K060226) |
Device Description:
The ACCEL system is the internal name for the Siemens program which includes the ONCOR Linear Accelerator product lines. The newest member of the ACCEL systems is the ARTISTE MV SATM Linear Accelerator product. The ARTÍSTE MV SA™ is composed of upgraded hardware, firmware and software as standard features.
Intended use:
The intended use of the ARTÍSTE MV SA™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ARTÍSTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.
The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications.
Summary of technological characteristics:
The ARTISTE MV SA™ linear accelerator does not have significant changes in materials, energy source or technological characteristics as compared to the predicate device. The intended use, indication for use and the fundamental scientific technology are the same as the predicate device and therefore we believe it is substantially equivalent to the predicate device.
Substantial equivalence:
The ARTÍSTE MV SA™ linear accelerator is substantially equivalent to the ONCOR EXPRESSION with COHERENCE Workspaces (K060226) in that it provides x-ray radiation for therapeutic treatment of cancer.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized lines, possibly representing an eagle or a similar bird.
Public Health Service
DEC 2 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions USA, Inc. % Mr. Erik Rodriguez Senior Software Quality Engineer Certified Compliance Solutions, Inc. (CCS, Inc) 16787 Bernardo Center Drive SAN DIEGO CA 92128
Re: K072485
Trade/Device Name: ARTISTE MV SATM Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 28, 2007 Received: November 28, 2007
Dear Mr. Rodriguez:
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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdri/industry/support/index.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
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SIEMENS
Indications for Use Statement Section 4 510(k) Number: K077403
Device Name: ARTÍSTE MV SATM
Indications for Use:
The intended use of the ARTÍSTE MV SA™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ARTISTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.
The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications with these embedded features:
- patient data management, selection and setup by use of a local, on-board database, .
- treatment delivery/verification and treatment recording by use of on-board applications, .
- Megavoltage Cone Beam acquisition method for acquiring projection data for 3D . reconstruction.
- Patient positioning verification by use of the OPTIVUE imaging system, including . MVision™(Cone Beam acquisition and reconstruction and the Adaptive Targeting application).
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aruith Wh
luctive. Abdomin 510(k) Number
§ 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.