(88 days)
The TeraRecon RTR-2000 Image Reconstruction System should be used when it is desirable to view scanned medical images immediately, rather than wait long periods of time for reconstruction. Indications would include monitoring of radiological examinations for patient movement. It is possible that patient movement during the middle of an examination, which may require re-scanning, would not be detected until after the completion of the exam when all of the images are reconstructed and thus visualized. High speed image reconstruction allows for real-time visualization of the images. Such real-time visualization of images gives the immediate visual feedback necessary to monitor the progress of examinations in efforts to maximize scanning accuracy and minimize radiation dose to the patient.
In short, real-time visualization of images is indicated in cases where the user prefers immediate visual feedback as opposed to having to wait long periods of time for image reconstruction.
The TERARECON, INC. RTR-2000 real-time image reconstruction system acquires medical image data from such medical imaging devices as CT and reconstructs the "raw" data into visible images. The RTR-2000 system reconstructs images with such high performance that the images This stand-alone high performance image are viewed in real-time. reconstruction system is offered as an upgrade to existing imaging devices, and is not intended to replace the devices' existing reconstruction system. Rather, it is intended to serve as an alternative means of viewing medical images, particularly where real-time visualization of images is beneficial.
Here's a breakdown of the acceptance criteria and study information for the RTR-2000 Medical Image Reconstruction and Processing Systems, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Real-time Image Reconstruction | Ability to reconstruct images with high performance for real-time viewing. | The RTR-2000 system reconstructs images with such high performance that the images are viewed in real-time. |
| Image Quality | Produce visible images from "raw" medical image data. | The device acquires medical image data...and reconstructs the "raw" data into visible images. (No specific quality metrics are provided, but the outcome of "visible images" is stated). |
| Throughput Improvements | Provide solutions to medical image reconstruction throughput problems. | Offers enhanced operator flexibility and dramatically speeding up the image reconstruction process. |
| Safety and Effectiveness | No new intended uses that will affect the safety and effectiveness of the host system. | Other than dramatically speeding up the image reconstruction process, there are no perceived or imagined new intended uses which will affect the safety and effectiveness of the host system. |
| Clinical Utility | Allow for near real-time viewing, supporting existing system clinical uses. | Allows for near real-time viewing, in turn, supporting existing system clinical uses by offering enhanced operator flexibility. Indicated for monitoring of radiological examinations for patient movement to maximize scanning accuracy and minimize radiation dose. |
Study Information
It's important to note that the provided 510(k) summary is primarily a regulatory document for demonstrating substantial equivalence. It does not describe a detailed clinical study in the way a modern clinical trial report would. Instead, the "study" demonstrating acceptance is largely based on the comparison to a predicate device and the inherent functional description of the new device.
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The document states the device acquires medical image data from such medical imaging devices as CT, but doesn't detail the origin or characteristics of the test data used for validation. Given the era (1997) and the nature of the submission for an image reconstruction system (as opposed to a diagnostic AI), specific test sets for performance metrics like accuracy are typically not publicly detailed in these types of submissions, if they were used at all beyond internal engineering validation.
- Retrospective or Prospective: Not specified. Implied to be a functional demonstration rather than a formal clinical study with retrospective or prospective data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. There is no mention of expert-established ground truth in the context of what would typically be a diagnostic performance study. The "ground truth" here is implied to be the accurate reconstruction of images for real-time viewing.
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Adjudication method for the test set: Not applicable. No formal adjudication process is described as there isn't a human diagnostic decision being evaluated for accuracy against ground truth.
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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: Not applicable. This document does not describe an MRMC study. The device is for image reconstruction and processing, improving throughput, not for diagnostic assistance that would typically be evaluated in an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The core function of the device is image reconstruction, which is an algorithmic process. The claim is that the system (algorithm + hardware) performs this reconstruction in real-time. The "performance" described is the speed and ability to generate visible images, which is a standalone algorithmic function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly described in terms of a clinical "ground truth" for diagnostic accuracy. The ground truth for this device's performance would be the accurate and complete reconstruction of the input raw data into a visible image. This is a technical ground truth rather than a clinical one.
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The sample size for the training set: Not applicable/Not specified. This is a real-time image reconstruction system, not a machine learning model that would typically have a "training set" in the modern sense. Its development would involve engineering, signal processing, and optimization, rather than training on a dataset of labeled images.
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How the ground truth for the training set was established: Not applicable/Not specified, for the reasons mentioned above.
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| C1 | C41001220 | |
|---|---|---|
| -- | -------- | --------------------------- |
510(k) Summary
| Date: | November 13, 1997 |
|---|---|
| Submitter: | Gary J. Allsebrook, Regulatory Affairsfor/ TERARECON, INC.280 Utah AvenueSuite 100South San Francisco, CA 94080 |
| Contact: | Gary J. Allsebrook, Regulatory AffairsTEL: (510) 276-2648 FAX: (510) 276-3559 |
| Device Name: | RTR-2000 Medical Image Reconstruction andProcessing Systems |
| Common Name: | Image Processing Workstation |
| Classification Name: | System, Image Processing |
| Classification: | Class II |
| Procode: | 90LLZ |
| EstablishmentRegistration Number: | Application in Process |
| Predicate Device: | Toshiba TSFX-001A, Real-Time ReconstructionSystem Option for Xpress/SX CT System, K950973 |
Device Description: The TERARECON, INC. RTR-2000 real-time image reconstruction system acquires medical image data from such medical imaging devices as CT and reconstructs the "raw" data into visible images. The RTR-2000 system reconstructs images with such high performance that the images This stand-alone high performance image are viewed in real-time. reconstruction system is offered as an upgrade to existing imaging devices, and is not intended to replace the devices' existing reconstruction system. Rather, it is intended to serve as an alternative means of viewing medical images, particularly where real-time visualization of images is beneficial.
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Intended Use of this Device: The intended use of the device is to provide solutions to various medical image reconstruction throughput problems through the application of high speed image image processing devices and software, specifically. 2D and 3D reconstructions for CT scanners, MRI scanners and Ultrasound and other related radiological image host systems. It will allow for near real-time viewing, in turn, supporting existing system clinical uses by offering enhanced operator flexibility.
Comparison to Predicate Device: The RTR-2000 is similar to the Toshiba Real-Time Reconstruction System Model TSXF-001A, K950972, in that it is an upgraded version (supplement) of the host viewing system. As in the predicate device, the features provide user flexibility and improvements to the image processing throughput. Other than dramatically speeding up the image reconstruction process, there are no perceived or imagined new intended uses which will affect the safety and effectiveness of the host system.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
TeraRecon, Inc. c/o Gary J. Allesbrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116
Re:
K974307 RTR-2000 (Image Processing Workstation ) Dated: November 13, 1997 Received: November 17, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Allesbrook:
We have reviewed your Section 510K) 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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 100(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 question 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" (21 CFR 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/cdrb/dsmamain.html" -- ------------------------------------------------------------------------------------------
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name: TeraRecon RTR-2000 Image Reconstruction System
Indications for Use:
The TeraRecon RTR-2000 Image Reconstruction System should be used when it is desirable to view scanned medical images immediately, rather than wait long periods of time for reconstruction. Indications would include monitoring of radiological examinations for patient movement. It is possible that patient movement during the middle of an examination, which may require re-scanning, would not be detected until after the completion of the exam when all of the images are reconstructed and thus visualized. High speed image reconstruction allows for real-time visualization of the images. Such real-time visualization of images gives the immediate visual feedback necessary to monitor the progress of examinations in efforts to maximize scanning accuracy and minimize radiation dose to the patient.
In short, real-time visualization of images is indicated in cases where the user prefers immediate visual feedback as opposed to having to wait long periods of time for image reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 901.109)
Over-the-Counter Use
David A. Siyer (Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devic
510(k) Number _
OR
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.