(69 days)
The software is to be used for the remote viewing of files generated by a medical scanning device and acquired according to the dominant industry-standard communications format (DICOM 3.0).
The software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation.
AMICAS is an integrated client-server software system designed to allow access to medical inages by radiologists, referring physicians and other licensed professionals. This product is intended to allow the review of images on a digital Picture Archive and Communication System (PACS) network using a personal computer or workstation configured for standard Internet access. The server component of AMICAS is installed on a computer configured with connections to both the PACS and the Internet. Typically, images will be accessed through a World Wide Web (WWW) browser (the client) such as Microsoft Internet Explorer or Netscape Navigator. Radiology workstations can Query and Retrieve images from AMICAS using standard DICOM protocols.
AMICAS can be used for image distribution within a hospital, a managed care organization or an isolated imaging center. It can also serve as a telemedicine link between widely separate organizations.
Here's a breakdown of the acceptance criteria and study information for the AMICAS Web/Intranet Image Server based on the provided document:
This device is not an AI/ML powered device, so several of the requested sections (e.g., MRMC study, standalone performance) are not applicable. The device is an image communication device, essentially a PACS viewer, that utilizes lossy compression. The primary "study" described is a clinical collaboration and experience, rather than a formal pre-market clinical trial as one might expect for a diagnostic AI device today.
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission from 1997 for an image communication device (PACS viewer) that utilizes lossy compression, the concept of "acceptance criteria" is primarily focused on demonstrating equivalence to predicate devices and ensuring the compressed images retain sufficient diagnostic quality. The document doesn't present explicit "acceptance criteria" in a typical numerical format for diagnostic accuracy or sensitivity/specificity. Instead, it relies on demonstrating that its image compression ratios are "consistent with" and "substantially equivalent to" those used in already cleared devices and clinical practice.
| Acceptance Criteria (Inferred from Equivalence Claim & Clinical Practice) | Reported Device Performance (as described for specific modalities) |
|---|---|
| Wavelet compression technology substantially equivalent to predicate (RSTAR K943994) | Uses Aware, Inc. wavelet libraries (same as RSTAR) |
| Target compression ratios consistent with clinical experience and predicate device | CR: 23:1 (actual), 30:1 (displayed); CT: 11:1 (actual), 15:1 (displayed); MR: 6:1 (actual), 8:1 (displayed) |
| Diagnostic accuracy maintained post-compression (based on clinical experience and academic reference) | "Three years of clinical experience with wavelet compression at Massachusetts General Hospital" & reference to Goldberg et al. 1993 study on diagnostic accuracy of teleradiology system. |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" for this specific device's evaluation. The submission refers to a "three years of clinical experience" at Massachusetts General Hospital (MGH) with wavelet compression, which served as the basis for setting target compression ratios.
- Data Provenance: Massachusetts General Hospital (MGH), Boston, MA. This would be considered retrospective experience with the underlying compression technology, not a prospective trial specifically for AMICAS itself. The cited academic reference (Goldberg et al. 1993) involved a prospective study of 685 transmitted clinical cases but was conducted on a different teleradiology system using wavelet compression, serving as an academic reference for the technology itself, not direct evidence for AMICAS.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "three years of clinical experience" at MGH, the "experts" were the clinical radiologists and practitioners at the hospital who used the wavelet compression technology in their daily workflow. No specific number is provided, nor strict qualifications beyond being "radiologists" as implied by the context of "Massachusetts General Hospital (MGH), Boston, MA" and "collaborated with the Radiology Associates of Massachusetts General Hospital (MGH)".
- For the Goldberg et al. (1993) reference, the study involved radiologists reading transmitted images, but specific numbers and qualifications related to ground truth establishment for their study are not detailed in this document.
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Adjudication method for the test set:
- Not applicable/Not described. The "study" here is more of a validation of the compression ratios based on real-world clinical use and equivalence to a predicate device, rather than a formal diagnostic accuracy study with a specific adjudication process.
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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:
- No. This is a 1997 submission for a PACS viewer (an image communication device), not an AI/ML powered device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, as the algorithm's performance (image compression ratios and visual quality post-compression) was evaluated "alone" in the context of its output, but not as a diagnostic algorithm. The "test data and conclusions" primarily refer to the automatic selection of target compression ratios by AMICAS. The document explicitly states: "The software... It does not provide a diagnosis. It provides information/data only."
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The type of ground truth used:
- For the "three years of clinical experience" at MGH, the ground truth was implicitly clinical diagnosis and radiologist interpretation of images compressed using wavelet technology, established over time in routine clinical practice. The absence of reported issues with diagnostic accuracy at those compression ratios informed the "acceptance."
- The Goldberg et al. 1993 reference abstract suggests diagnostic accuracy of transmitted clinical cases.
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The sample size for the training set:
- Not applicable/Not explicitly defined. This device does not use a "training set" in the machine learning sense. The "training" for the compression ratios was derived from "three years of clinical experience with wavelet compression at Massachusetts General Hospital," which implies a very large, ongoing dataset of real-world clinical images over that period.
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How the ground truth for the training set was established:
- Not applicable/Not explicitly defined. As there is no "training set" in the ML sense, there's no ground truth established for it. The general "ground truth" for the clinical experience that informed the compression ratios was the standard of care for radiological diagnosis at MGH.
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autocytgroup, inc.
MAR 1 7 1997
52 Marshall Street Watertown, MA 02172 800 490 8465 617 926 4170 fax
NO/ヨロのバイクロウ/ダ
SAFFOR
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, MD 20850
510(k) Summary
1. Identification
- January 6, 1997 Date:
- Submitter: Adrian Gropper, M.D.
Autocyt Group, Inc. 52 Marshall Street Watertown, MA 02172
- Adrian Gropper, M.D. Contact: 617-925-5329 617-926-4170 (fax)
2. Device Name
| Trade Name: | AMICAS Web/Intranet Image Server |
|---|---|
| Common Name: | Image Communication Device |
3. Registration Number
None
4. Classification
| Class: | 2 |
|---|---|
| Panel: | RA |
| Product Code: | SYSTEM, DIGITAL IMAGE COMMUNICATIONS |
5. Standards
None established. Performance: Voluntary: ACR/NEMA DICOM 3.0
6. Labeling
See Section 3
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7. Safety and Effectiveness Information
AMICAS is an imaging software program used to view medical images on a personal computer. The software is designed to function with off the shelf hardware and software products including standard communications products. It does not require specialized, or nonstandard, devices of any type.
Image acquisition is via the industry-standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the scanner. Image acquisition does not depend on the capture of video signals.
The AMICAS software falls in the "Lower Level of Concern" category:
Intended Use: The software is to be used for the remote viewing of files generated by a medical scanning device and acquired according to the dominant industry-standard communications format (DICOM 3.0).
System and Software Requirements: The software will run on standard off-the-shelf hardware and system configurations.
Hazard Analysis: Incorrect display of the image data is possible due to incorrect data produced by the scanner or from a software malfunction. The method of control is through the current regulation of these devices by the FDA, and through the testing procedures adhered to during development and testing stages of this software prior to release. The corrective action is the intended use of this software with properly regulated devices, and timely identification and correction of these potential software problems and the subsequent testing procedures.
Factors Considered:
The risk or danger to the patient of using the device: The software can not immediately threaten the patient's life nor directly cause irreversible illness or permanent injury as it deals only with data gathered and processed by regulated devices and viewed by a competent medical professional.
Degree of influence on therapy or diagnosis: The device does not control the delivery of energy, administration of parenteral drugs, or life-sustaining functions. It does not provide a diagnosis. It provides information/data only. It is a stand-alone system and not a part of a regulated classified device nor an accessory to it. Competent health professionals would reasonably be expected to exercise judgment in the use of the information.
The software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation.
Also see Appendix B for discussion of lossy image compression, example films and related data.
8. Photographs
See Section 4 for computer screen captures of principal views.
9. Device Description
AMICAS is an integrated client-server software system designed to allow access to medical inages by radiologists, referring physicians and other licensed professionals. This product is intended to allow the review of images on a digital Picture Archive and Communication System (PACS) network using a personal computer or workstation configured for standard Internet access. The server component of AMICAS is installed on a computer configured with connections to both the PACS and the Internet. Typically, images will be accessed through a World Wide Web (WWW) browser (the client) such as Microsoft Internet Explorer or Netscape Navigator. Radiology workstations can Query and Retrieve images from AMICAS using standard DICOM protocols.
AMICAS can be used for image distribution within a hospital, a managed care organization or an isolated imaging center. It can also serve as a telemedicine link between widely separate organizations.
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A radiology imaging device such as a CT, MR or CR scanner on the PACS network of one institution can be linked to the display workstations on the PACS network of another institution via AMICAS servers on each of the PACS. The AMICAS servers communicate with each other via the public Internet or a private intranet.
See Section 2 for device description and Appendix C for a Feature Summary (page C-29).
The user's Web browser is a major component of the AMICAS system. Appendix C includes the Initial Configuration document (page C-24) which discusses the characteristics of specific Web browsers in relation to the functioning of the AMICAS system.
10. Comparison with Equivalent Devices
AMICAS has Indications for Use similar to other medical image viewers such as Evergreen Technologies MedVision [ 510(k) Number K924178 ] or the RSTAR Image Management System [ 510(k) Number K943994 ]. AMICAS also shares with these devices a Target Population that is competent health professionals. Also equivalent to these devices, the AMICAS Design will operate with off-the-shelf hardware and systems.
Like the RSTAR Image Management System [ 510(k) Number K943994 ], AMICAS employs image compression to remove redundant or unimportant information in the original image data. The wavelet image compression libraries and default compression settings are believed to be substantially equivalent to the libraries used in the previously cleared product. Images showing the effect of compression are attached to this submission.
| Feature | MedVision [K924178] | RSTAR [K943994] | AMICAS |
|---|---|---|---|
| Indications for Use | Similar | Similar | Similar |
| Target Population | Health Professionals | Health Professionals | Health Professionals |
| Uses Off-the-ShelfMonitors | YES | NO | YES |
| Lossy ImageCompression | NO | YES | YES |
| Lossy CompressionTechnology | NO | Aware, Inc. | Aware, Inc. |
| DICOM Acquisition | YES | NO | YES |
| TCP/IPCommunications | YES | YES | YES |
Tabular Comparison with Equivalent Devices
11. Image Compression Technology
AMICAS employs wavelet compression software supplied by Aware, Inc., Bedford, MA. This component, together with the input parameters that are determined by the Autocyt Group software (see Appendix B) are the principal determinants of image quality. Aware is also the supplier of compression technology used in the RSTAR [K943994] product to which we claim equivalence.
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AMICAS has been developed and tested for over one year in collaboration with the Radiology Associates of Massachusetts General Hospital (MGH), Boston, MA. The founders of Autocyt Group have extensive experience with the design and implementation of systems that employ wavelet image compression. Adrian Gropper, M.D. has been a technical consultant to MGH for over 4 years and was the senior system architect of the RSTAR telemedicine system. Sean Doyle, AMICAS lead software developer, was Director of Software at RSTAR for the equivalent product.
The principal academic reference for clinical use of wavelet compression is:
Goldberg MA, Rosenthal DI, Chew FS, Blickman JG, Miller PR. New high-resolution teleradiology system: prospective study of diagnostic accuracy in 685 transmitted clinical cases. Radiology 1993; 186: 429-434
12. Test Data and Conclusions
Appendix B presents typical performance data and includes original films as examples of device operation.
AMICAS automatically selects a target compression ratio based on the modality information supplied in the DICOM header of each image. This target compression ratio is based on three years of clinical experience with wavelet compression at Massachusetts General Hospital, Boston, MA and is consistent with the typical compression ratios used in the RSTAR Image Management System [510k Number K943994].
| Modality | Target Compression Ratio based onTypical Information Content | Target Compression Ratio asDisplayed to the User |
|---|---|---|
| CR | 23:1 | 30:1 |
| CT | 11:1 | 15:1 |
| MR | 6:1 | 8:1 |
AMICAS target compression ratios are set to:
13. Software Information
See Sections 4 and 6 and Appendix D.
14. Confidentiality
Portions of the attached enclosure are confidential.
We would appreciate the earliest attention to this 510(k) submission. We are a small business and are depending on AMICAS sales. Please do not hesitate to contact me at 617-924-5329 or via pager at 617-362-8002 if you have questions regarding this submission.
Sincerely,
Adria Groop, MD.
Adrian Gropper, I President enclosure
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.