(83 days)
Intended for use to independently review and process anglographic images outside the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different modalities for the same patient on the same workstation to further support diagnosis and treatment planning.
Not Found
The provided text is a summary of a 510(k) premarket notification for the "AX Workstation," an angiographic x-ray system. This document focuses on establishing substantial equivalence to previously marketed devices rather than presenting detailed acceptance criteria and a study proving performance against them in the way a clinical trial for a novel AI diagnostic might.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and detailed study methodologies is not present in the provided text. The document is primarily concerned with regulatory clearance based on the device's functional similarity to existing and legally marketed devices.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) submission focuses on demonstrating "substantial equivalence" of the new device to existing predicate devices (Siemens TOP ACOM Station and Camtronics Analytical Review Station). Substantial equivalence means that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. It does not typically involve presenting specific, quantitative acceptance criteria met through a performance study in the same way a de novo device or a novel AI algorithm might.
The "performance" described is functional similarity: "Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions." This is a statement of intended functionality, not a metric with an acceptance threshold.
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not provided. No specific test set or associated sample size is mentioned.
- Data provenance: Not applicable/Not provided. Since no specific test set is detailed, there's no information on data provenance (e.g., country of origin, retrospective/prospective). The document implies the functionalities are derived from existing Siemens angiography systems.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
This type of information is usually relevant for studies validating diagnostic accuracy, which is not the primary focus of this 510(k) for a review workstation.
4. Adjudication method for the test set:
- Adjudication method: Not provided. As no test set is detailed, no adjudication method is mentioned.
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:
- MRMC study: Not provided. The document describes a "review workstation" for angiographic images, which provides image processing and viewing functions. It does not describe an AI algorithm or a comparative effectiveness study involving human readers with and without AI assistance. The term "AI" is not present in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance study: Not provided. This device is a workstation designed for human interaction and review; it's not described as a standalone algorithm performing automated diagnosis.
7. The type of ground truth used:
- Type of ground truth: Not applicable/Not provided. As there's no described performance study requiring a ground truth (e.g., for diagnostic accuracy), no type of ground truth is mentioned. The device's purpose is to assist diagnosis, not to make a diagnosis itself, implying human experts will establish the final diagnostic ground truth in clinical practice.
8. The sample size for the training set:
- Sample size for the training set: Not provided. This document does not describe any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: Not applicable/Not provided. Since no training set is described, no method for establishing its ground truth is mentioned.
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SEP 9 1999
Summary Of Safety and Effectiveness
l. General Information Classification Name: Classification Number: Class of Device: Common/Usual Name: Device Trade Name:
Angiographic x-ray system 21 CFR 892.1600 = review workstation AX Workstation
Siemens Medical Systems, Inc.
Intended Use: Intended for use to independently review and process anglographic images outside the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different modalities for the same patient on the same workstation to further support diagnosis and treatment planning.
Establishment Name and Address:
| Nuclear Medicine Group | |
|---|---|
| 2501 North Barrington Road | |
| Hoffman Estates, IL 60195-5203 | |
| Establishment Registration | |
| Number: | 1423253 (Owner/Operator 9010023) |
| Performance Standard: | None established under Section 514 of The |
Il Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.
Substantial Equivalence:
The AX Workstation is substantially equivalent to currently marketed Siemens Medical Systems. Inc. TOP ACOM Station (K945293) with accessory ACOM.PC+ and Camtronics Analytical Review Station (K955519).
Contact:
Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-5203 Phone: (847) 304-7516 Fax: (847) 304-6023 E-Mail: robert.callahan@nmg.sms.siemens.com
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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 an eagle or bird in flight, composed of three curved lines.
SEP . g 1999
Mr. Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-5203
Dear Mr. Callahan:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K992073 Re: AX Workstation Dated: June 17, 1999 Received: June 18, 1999 Regulatory Class: II (two) Product Code: 90 LLZ 21 CFR 892.2050
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, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), 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 equivalent determination 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 notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Qther 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known)_K 9920Z3
Device Name: AX Workstation
Indication for Use:
AX Workstation will be used to independently review and process angiographic images outside of the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different imaging modalities for the same patient on the same workstation to further support diagnosis and treatment planning.
PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of the CDRH, Office of Device Evaluation (O,DE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Or
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).