(20 days)
The intended use of the JET software is to get high-resolution anatomical images with minimal artifacts due to physiologic motion which can interfere with image quality. This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions.
Imaging of:
Any anatomies that can have the artifact caused by the physiologic motion such as:.
- CSF flow .
- Abdominal or chest wall movement due to the breathing .
- Respiratory movement on shoulders .
- Uncontrolled movements due to the stroke, pediatric or uncooperative patients ●
JET software provides high-resolution anatomical images with minimal artifacts due to physiological motion, which is caused by movement of anatomical regions due to breathing, CSF flow or other involuntary movements and can interfere with image quality.
The provided text is a 510(k) Premarket Notification for the Toshiba America Medical Systems, Inc. JET Software. The document focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the other requested details regarding the study design and ground truth establishment.
Here's a breakdown of the information that can be extracted and the information that is missing:
The submission is primarily focused on demonstrating substantial equivalence to a previously cleared device (K063361), implying that the performance is expected to be similar or better without a need for a new comprehensive performance study against specific acceptance criteria. The approval indicates the FDA found the device substantially equivalent based on the information provided, which likely includes technical comparisons rather than a full clinical performance study with defined acceptance criteria and statistical analysis against those criteria.
1. A table of acceptance criteria and the reported device performance
-
Acceptance Criteria (Extrapolated from Intended Use/Device Description):
- Produce high-resolution anatomical images.
- Minimize artifacts due to physiological motion (e.g., CSF flow, breathing, uncontrolled movements).
- Improve signal-to-noise ratio by eliminating or reducing image degradation caused by motions.
-
Reported Device Performance: The document states that the "Algorithm was modified to support a new combination of image acquisition and reconstruction techniques." It also claims that the software is expected to "get high-resolution anatomical images with minimal artifacts due to physiologic motion... This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions."
- Direct performance metrics against explicit acceptance criteria are NOT provided in the submission. The submission is a justification of substantial equivalence, not a detailed performance study with quantitative results.
Missing Information (Not Available in the Provided Text):
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document does not describe a "test set" in the context of a performance study.
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)
- Not applicable/Not specified. Ground truth establishment for a test set is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- Not specified. The document focuses on the software's image quality improvement, not on its impact on human reader performance in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly described as a standalone study with quantitative metrics. The device itself is software (an algorithm), and its intended function is to improve image quality. The claim of "high-resolution anatomical images with minimal artifacts" and "improvements on signal-to-noise" implies a standalone performance, but no specific study design or results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Given the nature of the device (image quality improvement for motion artifacts), ground truth would likely involve expert visual assessment of artifact reduction and image clarity, but this is not detailed.
8. The sample size for the training set
- Not specified. The document does not mention a "training set" for the algorithm, as it predates the common terminology for deep learning models. It discusses algorithm modifications and new acquisition/reconstruction techniques.
9. How the ground truth for the training set was established
- Not applicable/Not specified. No training set is mentioned in the context of ground truth.
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K073081
Page 1 of 2
Toshiba America Medical Systems, Inc.
510(k) Premarket Not JET Software for Excelart VantageTM Atlas-Z, Atlas-X
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name | Magnetic Resonance Diagnostic Device Accessory | |
|---|---|---|
| Model Name: | MRT-1503/S5, MRT-1503/S3 | |
| Trade/Proprietary Name | JET Software for EXCELART™ Vantage Atlas-Z, Atlas-X | |
| 2. Establishment Registration No.: | 2020563 | |
| 3. U.S Agent Name and Address: | Toshiba America Medical Systems, Inc.2441 Michelle DriveTustin, CA 92780 | |
| Contact Person: | Paul Biggins(714) 730-5000 | |
| 4. Manufacturing Site: | Toshiba CorporationMedical Systems Company1385 ShimoishigamiOtawara-shi, Tochigi 32408550, Japan | |
| 5. Date of Submission: | October 26, 2007 |
6. DEVICE DESCRIPTION
JET software provides high-resolution anatomical images with minimal artifacts due to physiological motion, which is caused by movement of anatomical regions due to breathing, CSF flow or other involuntary movements and can interfere with image quality.
6.1. Summary Of Major Hardware Changes
None
6.2. Summary Of Major Software Changes
Algorithm was modified to support a new combination of image acquisition and reconstruction techniques.
7. IMAGING PERFORMANCE PARAMETERS
No changes from the previously cleared K063361.
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Toshiba America Medical Systems, Inc.
510(k) Premarket Notification JET Software for Excelart Vantage™ Atlas-Z, Atlas-X
8. INTENDED USE
The intended use of the JET software is to get high-resolution anatomical images with minimal artifacts due to physiologic motion which can interfere with image quality. This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions. The software will be effective for any anatomies that can have the artifact caused by the physiologic motion such as below.
-
CSF flow
-
Abdominal or chest wall movement due to the breathing
- A Respiratory movement on shoulders
- A Uncontrolled movements due to the stroke, pediatic or uncooperative patients
9. EQUIVALENCY INFORMATION
Toshiba Medical Systems Corporation believes that the EXCELART Vantage Atlas-Z and Atlas-X (models MRT-1503/S5, MRT-1503/S3) Magnetic Resonance Imaging (MRI) System with JET software is substantially equivalent to the following:
- · EXCELART Vantage Atlas-Z and Atlas-X (models MRT-1503/55, MRT-1503/S3) cleared November 21, 2006 (K063361).
- · "PROPELLER" manufactured by GE Medical Systems cleared May 2, 2003 (K031230), which uses a similar technique to reduce the motion-related artifact.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
NOV 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K073081
Trade/Device Name: JET Software for EXCELART Vantage Atlas-Z, EXCELART Vantage
Atlas-X
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH
Dated: October 31, 2007
Received: November 1, 2007
Dear Mr. Job:
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 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 begin 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
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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Attachment 1
Indications for Use
K073081 510(k) Number (if known): __
Device Name: JET Software for EXCELART Vantage Atlas-Z, EXCELART Vantage Atlas-X
Indications for Use:
The intended use of the JET software is to get high-resolution anatomical images with minimal artifacts due to physiologic motion which can interfere with image quality. This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions.
Imaging of:
Any anatomies that can have the artifact caused by the physiologic motion such as:.
- CSF flow .
- Abdominal or chest wall movement due to the breathing .
- Respiratory movement on shoulders .
- Uncontrolled movements due to the stroke, pediatric or uncooperative patients ●
Prescription Use (Part 21 CFR 801Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
5
Lorai Móz
an-Off) (Division Division of Reproductive, Abdominal an Radiological Devices 510(k) Number
§ 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.