(78 days)
Imaging of:
- The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR neok, Ywis, Hoard Broomy), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization ●
- 2D/3D Imaging .
- Mr Angiography/MR Vascular Imaging .
Version 2.5/V2.6 software is a combination of modifications and the enhancement of sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. This software will function on both SGI Indigo 2 and O2 computer workstations. The V2.6 software may also be identified as Performance Plus option.
The provided document is a 510(k) Premarket Notification for a diagnostic magnetic resonance device (OPART™ version 2.5/2.6 software for MRT-600) from 1999. It focuses on the safety and imaging performance parameters of the MR system and its software updates. It does not contain information related to a clinical study with acceptance criteria for a device's diagnostic performance, nor does it describe a study involving human readers, ground truth establishment, or multi-reader multi-case analysis as typically seen for AI/CAD devices.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the document:
1. A table of acceptance criteria and the reported device performance
The document lists "Safety Parameters" and "Imaging Performance Parameters" which function as specifications for the device. These are accepted as meeting the requirements for substantial equivalence.
| Acceptance Criteria Category | Specific Parameter | Accepted Value/Description |
|---|---|---|
| Safety Parameters | Maximum static field strength | 0.35 Tesla |
| Rate of change of magnetic field | 19T/second | |
| Maximum radio frequency power deposition (SAR) | <0.4Watt/kg | |
| Acoustic noise levels (maximum) | 98.4 dB (A) | |
| Imaging Performance Parameters | Specification volume (Head) | 10cm |
| Specification volume (Body) | 20cm | |
| New sequences conformance | Demonstrated conformance with consensus standards for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing via sample phantom and clinical images. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "sample phantom images and clinical images" were presented, but no details on the sample size, provenance, or study design are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The evaluation of imaging performance relies on "consensus standards requirements," implying expert review or established metrics, but specifics on the number or qualifications of experts are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described. This document pertains to the software update of an MR imaging system itself, not an AI or CAD system designed to assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes the performance of the MR imaging system and its software, which acquires and reconstructs images. Its performance is inherently "standalone" in terms of image generation, but it's not an algorithm that performs diagnostic interpretation without a human-in-the-loop. It confirms the physical and imaging quality of the system, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Imaging Performance Parameters," the "ground truth" or reference standard appears to be consensus standards requirements for objective metrics like Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing. This is based on physical or technical measurements and comparisons, rather than clinical ground truth like pathology or outcome data.
8. The sample size for the training set
This information is not provided in the document. The software update (version 2.5/2.6) enhances sequences and does not imply a "training set" in the context of machine learning, which wasn't prevalent for such regulatory submissions in 1999.
9. How the ground truth for the training set was established
This information is not provided in the document and is not applicable in the context of this type of device and submission from 1999.
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APH 1 3
510(k) Premarket Notification
Summary of Safety and Effectiveness
- Magnetic Resonance Diagnostic Device 1. DEVICE NAME: Accessorv MRT - 600 Model Number: OPART™ Trade/Proprietary Name: 293623 2. ESTABLISHMENT REGISTRATION: Toshiba America MRI. Inc. 3. U.S. AGENT Name and Address: 280 Utah Avenue South San Francisco, CA 94080 Bruce Clark Contact Person: (650) 742-6068 Toshiba America MRI, Inc. 4. Manufacturing Site: 280 Utah Avenue South San Francisco, CA 94080 January 25, 1999 5. Date of Submission:
6. DEVICE DESCRIPTION:
Version 2.5/V2.6 software is a combination of modifications and the enhancement of sequences to the existing software, which facilitate the acquisition and reconstruction of This software will function on both SGI Indigo 2 and O2 computer MR images. workstations. The V2.6 software may also be identified as Performance Plus option.
7. SAFETY PARAMETERS:
| Maximum static field strength: | 0.35 Tesla |
|---|---|
| Rate of change of magnetic field: | 19T/second |
| Maximum radio frequency power deposition (SAR): | <0.4Watt/kg |
| Acoustic noise levels (maximum): | 98.4 dB (A) |
Note: These safety parameters remain unchanged from previous submissions.
8. IMAGING PERFORMANCE PARAMETERS:
| Specification volume: | Head: | 10cm |
|---|---|---|
| Body: | 20cm |
Sample phantom images and clinical images are presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing.
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9. INTENTED USE
Head, body, extremity, spine, neck, TMJ, breast and heart Anatomical regions: Nuclei excited: Hydrogen Diagnostic imaging of the human body (including head, abdomen, Diagnostic use: breast, heart, pelvis, spine, blood vessels, limns, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
10. EQUIVALENCY INFORMATION:
Toshiba America MRI, Inc., believes that the OPART™ version 2.5/2.6 software is substantially equivalent to the OPART™ version 2 diagnostic resonance system software accessories in that it consists of modifications that do not raise new questions of safety or efficacy. This software does not introduce any new indications for use from those cleared in the Premarket Notifications for OPART™ version 2 diagnostic resonance systems 510(k) number K981475.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a bird-like figure with three lines representing its wings or feathers, and a human profile facing left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 15 1935
Bruce Clark QA Engineer Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 Re:
OPART™ (MRT-600) Dated: January 25, 1999 Received: January 27, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Clark:
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). 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 vour device is classified (see above) into either class III (Special Controls) or 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 requlatory 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 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/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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Page 1 of 1
510(k) Number (if known):
Indications for Use:
Imaging of:
- The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR neok, Ywis, Hoard Broomy), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization ●
- 2D/3D Imaging .
- Mr Angiography/MR Vascular Imaging .
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Perscription Use(Per 21 CFR§801.109) | ✓ |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use(Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
CONFIDENTIAL
| (Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices | |
|---|---|
| ---------------------------------------------------------------------------------------------- | -- |
510(k) Number K940260
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.