(77 days)
The AMICAS Diagnostic Workstation (ADW) is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard hardware. The ADW receives imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. It is the user's responsibility to ensure that monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
AMICAS Light Beam Workstation (ALBW) is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them in the way typically required for AI/Ml medical devices. This document is a 510(k) summary for a Picture Archiving Communication System (PACS) software, Amicas Light Beam Workstation (ALBW), which handles and displays medical images, not an AI/ML diagnostic algorithm.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) that an AI/ML diagnostic device would typically report. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on functional characteristics.
| Feature | ALBW (Reported Performance) | Acceptance Criteria (Implied by Predicate) |
|---|---|---|
| Software Only | Yes | Yes |
| Image Measurements | Yes | Yes |
| Multi-planar reformatting | Yes | Yes |
| Volume Rendering | Yes | Yes |
| Maximum Intensity Projection | Yes | Yes |
| Image editing | Yes | Yes |
| Printing | Yes | Yes |
| DICOM Images | Yes | Yes |
| Lossless JPEG2000 Compression | Yes | Not Applicable (Improvement over predicate) |
| Lossy JPEG2000 Compression | Yes | Not Applicable (Improvement over predicate) |
The "acceptance criteria" here are implied by the features of the predicate device (Voxar Plug'n View 3D, version 1.0). The ALBW device is deemed substantially equivalent because it performs the same core functions. The JPEG2000 compression features represent an enhancement over the predicate, not a criteria it had to meet.
2. Sample Size for Test Set and Data Provenance
The document states: "ALBW is tested with reference to its Software Requirements Specifications, as documented in the Verification Procedure included in this 510(k) filing." However, it does not provide any specific sample size for a test set or information regarding data provenance (e.g., country of origin, retrospective/prospective). This is a general statement about software testing, not a clinical validation study with a defined test set.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention any experts used to establish a ground truth for a test set. This type of analysis is typically performed for diagnostic devices where human expert consensus is needed to determine the correct diagnosis or finding that the device is being evaluated against. Since ALBW is a PACS workstation, its primary function is display and manipulation, not diagnostic interpretation itself, though it is used for interpretation by qualified professionals.
4. Adjudication Method
As no experts were mentioned for establishing ground truth, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This device is a PACS workstation, not an AI assistant intended to improve human reader performance for a specific task. Its primary function is to facilitate viewing and manipulation of images.
6. Standalone Performance Study
No standalone performance study is mentioned in the context of an AI/ML algorithm. The "testing" section refers to software requirements specification verification.
7. Type of Ground Truth Used
Given the nature of the device as a PACS workstation, no specific "ground truth" (like pathology, expert consensus, or outcomes data) is described for performance evaluation. The device is assessed based on its ability to correctly display and process images as per its specifications, not on its diagnostic accuracy against a clinical ground truth.
8. Sample Size for Training Set
The document does not mention any training set size. This indicates that the device is not an AI/ML model that would require a distinct training phase with a dataset.
9. How Ground Truth for Training Set was Established
Since there is no mention of a training set, there is no information on how its ground truth would have been established.
In summary: The provided 510(k) summary is for a PACS workstation (Amicas Light Beam Workstation) from 2002. This predates the widespread regulatory focus on AI/ML in medical devices and the specific types of performance studies and reporting (like those involving sensitivity, specificity, ROC curves, ground truth establishment, training/test sets, and MRMC studies) that are now standard for such devices. The "study" here consists of software verification against functional specifications and demonstrating substantial equivalence to a predicate device based on shared features.
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022970
510(k) Summary of Safety and Effectiveness - as required by section 807.92(c)
| Date prepared: | September 1, 2002 | |
|---|---|---|
| Submitted by: | Amicas, Inc.20, Guest St.Boston, MA 02135 | |
| Contact:Contact email:Contact Telephone:Contact Fax: | Patrice Nedelecpnedelec@amicas.com617-779-7858617-783-7209 or 617-779-7879 | |
| Device Trade Name:Device Common Name:Regulation number:Device Classification:Name:Predicate Device:Predicate Device Manufacturer: | Amicas Light Beam WorkstationPicture Archiving Communication System (PACS)892.2050Class IIDiagnostic WorkstationVoxar Plug'n View 3D, Version 1.0Voxar LimitedBonnington Bond2 Anderson Pl.Edinburgh, UK EH6 5NP | |
| Predicate Device 510(k) number:Date received:Decision date:Decision:Panel Code Device reviewed by:Panel Code Device classified by:Product Code:Regulation number:Device Classification: | K99265408/09/199911/05/1999Substantially equivalentRadiologyRadiologyLLZ892.2050Class II |
Device Description and intended use:
AMICAS Light Beam Workstation (ALBW) is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Typical users of ALBW are radiologists, technologists and clinicians.
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| Feature | ALBW | Voxar Plug'n View 3Dversion 1.0 |
|---|---|---|
| Software Only | Yes | Yes |
| Image Measurements | Yes | Yes |
| Multi-planar reformatting | Yes | Yes |
| Volume Rendering | Yes | Yes |
| Maximum Intensity | Yes | Yes |
| Projection | Yes | Yes |
| Image editing | Yes | Yes |
| Printing | Yes | Yes |
| DICOM Images | Yes | Yes |
| Lossless JPEG2000Compression | Yes | No |
| Lossy JPEG2000Compression | Yes | No |
Technological characteristics:
General Safety Considerations
ALBW software and the computer platform that it is installed on together constitute a system for the interpretation of medical image data by trained and qualified professionals. It is the user's responsibility to ensure that image quality, display quality, environmental lighting and other possible distractions are consistent with the clinical application. Refer to the instruction manuals for your specific computer and display hardware for information regarding installation, calibration and additional safety issues.
The ALBW includes tools for enlarging, highlighting and obscuring portions of an image relative to other portions. Inappropriate application of these tools can result in the obscuration of important anatomy and contribute to an erroneous interpretation. It is the user's responsibility to understand the effect of image manipulation tools and to apply in a manner consistent with the clinical application. The user must review the cautionary statements in the User's guide.
Be sure to limit access to patient data to authorized individuals who are fully trained and qualified to use this equipment.
Testing:
ALBW is tested with reference to its Software Requirements Specifications, as documented in the Verification Procedure included in this 510(k) filing. Functional testing is an integral part of Amicas, Inc. Product Development process, also included in this filing (see section G)
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2002
Mr. Patrice Nedelec Director, Quality Assurance and Regulatory Affairs Amicas, Inc. 20 Guest St. BOSTON MA 02135
Re: K022970
Trade/Device Name: Amicas Light Beam Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: September 1, 2002 Received: September 6, 2002
Dear Mr. Nedelec:
This letter corrects our substantially equivalent letter of November 22, 2002, regarding the incorrect address.
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 iddications for use stated in the enclosure) to legally marketed predicate devices marketed in interent commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmint or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drig and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You, Diug, therefore, market the device, subject to the general controls provisions of the Act. The greneral 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 an 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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Nedelec
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David A. Sezmann
Nora S. Bozeman
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 (if known): Ko22970
Device Name: Amicas Light Beam Workstation
Indications For Use:
The AMICAS Diagnostic Workstation (ADW) is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard hardware. The ADW receives imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. It is the user's responsibility to ensure that monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
(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 G. Loomis
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510(k) Number
§ 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).