(29 days)
- Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankie, wrist and elbow), and body (chest, abdomen and pelvis). MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
The 4ch Flex SPEEDER (MJAJ-192A), is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the human body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions mentioned above. The 4ch Flex SPEEDER (MAJA-192A) consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes. MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
This submission describes a new coil (4ch Flex SPEEDER, MJAJ-192A) for a Magnetic Resonance (MR) diagnostic device. The acceptance criteria and the study for this device primarily focus on safety and imaging performance, rather than diagnostic accuracy like an AI-powered system.
Here's an analysis of the provided text with respect to your request:
Acceptance Criteria and Device Performance
Since this is an MR coil, the acceptance criteria are not in terms of traditional diagnostic performance metrics like sensitivity/specificity but rather in physical and imaging quality characteristics. The document doesn't explicitly state a table of acceptance criteria with corresponding performance metrics in the format you requested, as it's a 510(k) summary for substantial equivalence to a predicate device. However, we can infer the key criteria that were assessed for safety and image quality.
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Parameters: | |
| Maximum static field strength | 3 T (Matches intended use with Toshiba Vantage Titan 3T MR System) |
| Maximum dB/dt | "1st operation mode specified in IEC60601-2-33 (2002)" (Compliance with standard) |
| Maximum SAR | "1st operation mode specified in IEC60601-2-33 (2002)" (Compliance with standard) |
| Peak and A-weighted Acoustic Noise Level | "Not applicable" (Implies the coil itself doesn't generate significant acoustic noise beyond the MRI system) |
| Biocompatibility | "All materials used in contact with the patient have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating." (Stated compliance) |
| Imaging Performance: | |
| Image Quality | "Sample phantom images and clinical images are presented in Appendix F & G." (Implies demonstration of sufficient image quality, likely visual comparison to predicate) |
| Anatomical Coverage | "The extremities, joints, and trunk of the human body" (As per intended use and coil flexibility) |
Study Information
The provided document describes a 510(k) submission for substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically doesn't involve a separate, large-scale clinical study for diagnostic efficacy in the way an AI algorithm might.
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Sample size used for the test set and the data provenance:
- The document mentions "Sample phantom images and clinical images are presented in Appendix F & G." However, it does not specify the sample size (e.g., number of patients or images) used for these clinical images.
- The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the study likely did not involve establishing a diagnostic ground truth with human experts in the typical sense for an AI device. The evaluation of an MR coil's performance usually involves technical experts (e.g., medical physicists, MRI technologists) and radiologists for visual image quality assessment, often without a formal "ground truth" establishment for diagnostic accuracy being explicitly detailed in a 510(k) summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a 510(k) for an MR coil, formal adjudication methods for diagnostic discrepancies are generally not applicable or described in this summary.
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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, an MRMC comparative effectiveness study was not done as this device is an MR coil, not an AI-powered diagnostic tool intended to assist human readers. Therefore, there is no effect size related to human reader improvement with or without AI assistance. The study focuses on the coil's intrinsic performance and equivalence to a predicate.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a passive MR coil, not an algorithm. Its performance is always in conjunction with an MR system and human operator/radiologist.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the imaging performance, the "ground truth" would likely be the visual quality and diagnostic utility of the images produced by the coil, often assessed by radiologists who compare them to images obtained with the predicate device. This is typically a qualitative or semi-quantitative expert assessment rather than a formal diagnosis-level ground truth like pathology for a disease. The summary states "Sample phantom images and clinical images are presented," indicating visual comparison was part of the evaluation.
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The sample size for the training set:
- Not applicable. This device is an MR coil, not an AI algorithm, so there is no training set in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
In summary: The provided document is a 510(k) summary for an MR coil, demonstrating substantial equivalence to a predicate device based on safety parameters and general imaging performance. It does not contain the detailed clinical study information typically found for AI/CAD devices relating to diagnostic accuracy, reader performance, or specific ground truth methodologies. The "study" here is primarily focused on technical verification and validation, along with qualitative assessment of clinical images to show equivalence.
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Image /page/0/Picture/0 description: The image shows the text "K112 366 p½" in bold black font. Below this text is the text "Appendix A" in a smaller, regular black font. The text is centered in the image and the background is white.
SEP 1 5 2011
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Classification and Device Name 1.
Classification Name
Magnetic Resonance Diagnostic Device
Model Number
MJAJ-192A
Trade/Propriety Name
4ch Flex SPEEDER
2. Establishment Registration
2020563
3. U.S. Agent Name and Address
Agent Name ·
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, CA 92780
Contact Person
Paul Biggins, Director Requlatory Affairs T: (714) 730-5000 F: (714) 730-1310 pbiggins@tams.com
4. Manufacturing Site
Toshiba Medical Systems Corporation (TMSC) 1385, Shimoishigami, Otawara-Shi, Tochigi 324-8550, Japan
5. Date of Submission
August 31, 2011
6. Device Intended Use
Field Strength
3 T
Resonant Nucleus
Hydrogen
Anatomical Region of Interest
.
The extremities, joints, and trunk of the human body
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Image /page/1/Picture/0 description: The image shows the text "K112366 p2/2 Appendix A". The text is in bold, and the font is sans-serif. The text is arranged in two lines, with "K112366 p2/2" on the first line and "Appendix A" on the second line. The text is black, and the background is white.
Diagnostic Use
Diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography, MR fluoroscopy and MRS
7. Device Description
The 4ch Flex SPEEDER (MJAJ-192A), is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the human body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions mentioned above.
The 4ch Flex SPEEDER (MAJA-192A) consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.
MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
8. Safety Parameter
Maximum static field strength
3 T
Maximum dB/dt
1st operation mode specified in IEC60601-2-33 (2002)
Maximum SAR
1st operation mode specified in IEC60601-2-33 (2002)
Peak and A-weighted Acoustic Noise Level
Not applicable
Biocompatibility
All materials used in contact with the patient have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating.
Imaging Performance Parameter 9.
Sample phantom images and clinical images are presented in Appendix F & G.
10. Equivalency Information
Toshiba Medical Systems Corporation believes that this 4ch Flex SPEEDER (Model Number MJAJ-192A is substantially equivalent to the current 4ch Flex SPEEDER (Model number MJAJ-197A, K111251).
11. Software
There is no software required for this coil.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba Medical Systems Corporation, JAPAN % Mr. Paul Biggins Director Regulatory Affairs/US Agent 2441 Michelle Dr. TUSTIN CA 92780
SEP 15 2011
Re: K112366
Trade/Device Name: 4ch Flex Speeder, MJAJ-192A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 16, 2011 Received: August 17, 2011
Dear Mr. Biggins:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 (2) CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Statel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K 117 366
Device Name:
4ch Flex SPEEDER, MJAJ-192A
Indications for Use:
- Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankie, wrist and 1. elbow), and body (chest, abdomen and pelvis).
MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Pastet
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K112366
Page 1 of
Indication for Use Page 1 of 1
§ 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.