(36 days)
The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
The GE 1.5T 8 Channel Torso Coil is a 12 element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. The device utilizes technology similar to the GE 8 Channel Cardiac Phased Array Coil (K022669), but is designed to image the torso, similar to the GE 3.0T Torso Phased Array Coil (K030495).
The provided text describes a 510(k) summary for a medical device, specifically the GE 1.5T 8 Channel Torso Coil. However, it does not contain the detailed information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria for software or AI-driven systems.
This document is for a magnetic resonance coil, which is a hardware component, not a software or AI device. The "Summary of Studies" section only states: "Testing was performed to demonstrate that the design of the 1.5T 8 Channel Torso Coil meet predetermined acceptance criteria." It does not provide any specifics about:
- The acceptance criteria themselves.
- The reported device performance against those criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study details.
These types of details are typically found in regulatory submissions for AI/ML-driven devices, which involve performance metrics like sensitivity, specificity, AUC, and their validation against clinical ground truth.
Therefore, based on the provided text, I cannot complete the table or answer the specific questions posed, as the information is not present for this type of device submission.
Below is a general template of how such an answer would be structured if the necessary information were available in the document:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [e.g., Sensitivity] | [e.g., ≥ 90%] | [e.g., 92.5% (95% CI: 90.1-94.5%)] |
| [e.g., Specificity] | [e.g., ≥ 80%] | [e.g., 85.3% (95% CI: 83.0-87.1%)] |
| [e.g., ROC AUC] | [e.g., ≥ 0.90] | [e.g., 0.93] |
| [Add other relevant metrics like PPV, NPV, F1-score, etc.] |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: [Number of cases/patients]
- Data Provenance: [e.g., Retrospective or Prospective, Country(ies) of origin, e.g., "Multi-site retrospective study across 3 hospitals in the US and Germany."]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: [e.g., 3]
- Qualifications of Experts: [e.g., "Board-certified radiologists, each with 10+ years of experience in abdominal imaging."]
4. Adjudication method for the test set:
- [e.g., "2+1 adjudication method: Initial consensus by two experts; in cases of disagreement, a third senior expert provided a final decision."]
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:
- [e.g., "Yes, a prospective MRMC study was conducted. Readers demonstrated a significant improvement in diagnostic accuracy (e.g., 15% increase in AUC) when using the AI-assisted workflow compared to reading without AI assistance."] (If not done, state "Not explicitly mentioned" or "No.")
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- [e.g., "Yes, a standalone performance evaluation was conducted using the test set described above."] (If not done, state "Not explicitly mentioned" or "No.")
7. The type of ground truth used:
- [e.g., "Histopathological confirmation (biopsy results) as the gold standard." or "Expert consensus derived from a panel of radiologists reviewing all available clinical and imaging data." or "Long-term patient outcomes data."]
8. The sample size for the training set:
- [Number of cases/patients]
9. How the ground truth for the training set was established:
- [e.g., "Similar to the test set, ground truth for the training set was established via expert consensus by a separate panel of board-certified radiologists." or "Leveraged existing annotated datasets from public repositories combined with internal expert labeling."]
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03/209
MAY 2 3 2003
GE Medical Systems
Page 1 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE Medical SystemsPO Box 414 (W-400)Milwaukee, WI 53201 |
|---|---|
| Contact Person: | Larry A. Kroger Ph.D.Manager, Regulatory Programs |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | April 16, 2003 |
Device Name:
GE 1.5T 8 Channel Torso Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS
Marketed Device:
The GE 1.5T 8 Channel Torso Coil is substantially equivalent to the currently marketed GE the 3.0T Torso Phased Array Coil (K030495) with the integration of the 8 channel technology in the currently marketed GE 8 Channel Cardiac Phased Array Coil (K022669).
Device Description:
The GE 1.5T 8 Channel Torso Coil is a 12 element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. The device utilizes technology similar to the GE 8 Channel Cardiac Phased Array Coil (K022669), but is designed to image the torso, similar to the GE 3.0T Torso Phased Array Coil (K030495).
Indications for Use:
The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The background is black, and the letters and border are white, creating a high-contrast design.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Comparison with Predicate Device:
The GE 1.5T 8 Channel Torso Coil is a modification of the GE 3.0T Torso Phased Array Coil (K030495), which presents an increase in the number of coil elements from four to twelve, and integrates the preamplifiers similar to the GE 8 Channel Cardiac Phased Array Coil (K022669). The GE 1.5T 8 Channel Torso Coil utilizes optimized geometry for parallel imaging (ASSET).
Summary of Studies:
Testing was performed to demonstrate that the design of the 1.5T 8 Channel Torso Coil meet predetermined acceptance criteria.
Conclusion:
It is the opinion of GE that the GE 1.5T 8 Channel Torso Coil is substantially equivalent to the GE 3.0T Torso Phased Array Coil (K030495), and the GE 8 Channel Cardiac Phased Array Coil (K022669). The usage of the GE 1.5T 8 Channel Torso Coil does not result in any new potential hazards.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2003
Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K031209 Trade/Device Name: GE 1.5T 8 Channel Torso Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 16, 2003 Received: April 17, 2003
Dear Dr. Kroger:
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 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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
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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KO31209
510(k) Number (if known):
Device Name: GE 1.5T 8 CHANNEL TORSO COIL Indications For Use:
The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻣﺴﺴﺴﺴﺴﺴﺴﺴﺴﻬﺎ ﻣﺮﺍﺳﻌﻪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟ Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR
Daniel R. Symm
(Division Sign-Off)
Division of Reproductiva, Abdominal,
and Radiological Devices
-10(k) Number K031209
§ 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.