The coil is indicated for use, on the order of a physician in conjunction with a 3.0T MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.

The primary applications associated with evaluation of the anatomy are as follows:

Thorax
Abdomen
Male and Female Pelvis
Prostate

Device Description

The 3.0T Torso Phased Array Coil is a four-channel phased array receive only MR coil used in conjunction with the GE 3.0T MR system.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to construct a table of acceptance criteria and reported device performance, nor does it describe a study with the specific elements requested (like sample sizes, ground truth establishment, or expert qualifications).

The document is a 510(k) summary for a medical device (3.0T Torso Phased Array Coil) and a subsequent FDA letter of substantial equivalence. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or a comprehensive list of acceptance criteria with measured performance metrics.

Here's what I can infer from the text, and where the requested information is missing:

Missing Information:

Specific Acceptance Criteria: The document states "Testing was performed to demonstrate that the design of the 4 channel 3.0T Torso Phased Array Coil meet predetermined acceptance criteria," but it does not list what those criteria are or what quantitative or qualitative performance metrics were used.
Reported Device Performance: Since the acceptance criteria are not specified, the document also does not report specific performance against these criteria.
Sample Size for Test Set: Not mentioned.
Data Provenance (Country, Retrospective/Prospective): Not mentioned.
Number of Experts for Ground Truth & Qualifications: Not mentioned, as no specific ground truth establishment is detailed for a clinical study.
Adjudication Method: Not mentioned.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as being performed. The document focuses on device characteristics and equivalence, not reader performance.
Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device (MR coil), not an algorithm.
Type of Ground Truth: Not explicitly stated for any testing, but implied to be related to image quality and system compatibility for an MR coil.
Sample Size for Training Set: Not applicable/not mentioned, as there is no machine learning algorithm being "trained" in this context.
How Ground Truth for Training Set was Established: Not applicable/not mentioned.

What the document does state (and why it doesn't fit your request format):

The document primarily describes:

Device Name: 3.0T Torso Phased Array Coil
Indicated Use: To produce images of the abdominal and pelvic regions in 2D and 3D with a 3.0T MR scanner, for applications like thorax, abdomen, male/female pelvis, and prostate imaging.
Substantial Equivalence: The key contention is that this device is substantially equivalent to two predicate devices:
- GE Medical Systems 1.5T Cardiac Phased Array (K971667)
- USA Instruments Torso and Pelvis Phased Array Coil (K001209)
Differences from Predicate: The main differences identified are:
- Tuning frequency (127.72MHz for 3.0T vs. 63.86MHz for 1.5T)
- Dimensions (34cm wide and 32cm long for 3.0T Torso vs. smaller for 1.5T Cardiac) for higher FOV coverage.
Conclusion: The device meets predetermined acceptance criteria and does not result in new potential hazards, leading to the conclusion of substantial equivalence.

In summary, this document is a regulatory submission focused on demonstrating equivalence and safety, not a detailed clinical trial report or performance study with the metrics you've requested.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a series of handwritten numbers. The numbers are 103 0495. The numbers are written in black ink on a white background.

MAR 0 5 2003

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 414Milwaukee, WI 53201
Contact Person:	Larry A. Kroger Ph.D.Manager, Regulatory Programs
Telephone:	262- 544-3894
Fax:	262- 548-4768
Date Prepared:	January 31, 2003

Device Name:

3.0T Torso Phased Array Coil Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-MOS

Marketed Device:

The 3.0T Torso Phased Array Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T Cardiac Phased Array (K971667) and USA Instruments Torso and Pelvis Phased Array Coil (K001209).

Device Description:

The 3.0T Torso Phased Array Coil is a four-channel phased array receive only MR coil used in conjunction with the GE 3.0T MR system.

Indications for Use:

The coil is indicated for use, on the order of a physician in conjunction with a 3.0T MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.

The primary applications associated with evaluation of the anatorny are as follows:

u Thorax
. Abdomen
트 Male and Female Pelvis
. Prostate

Comparison with Predicate Device:

The 3.0T Torso Phased Array Coil is a modification of the GE Medical Systems 1.5T Cardiac Phased Array Coil (K971667) with the main differences being that the 3.0T

{1}------------------------------------------------

Torso Phased Array Coil is tuned to 127.72MHz for operation at 3.0T instead of 63.86MHz for operation at 1.5T. In addition the dimensions of the 3.0T Torso Phased Array Coil (34cm wide and 32cm long) are larger than the dimensions of the 1.5T Cardiac Phased Array Coil for a higher FOV coverage requirement in case of the 3.0T Torso Phased Array coil. The technological similarities to the USA Instruments Torso and Pelvis Phased Array Coil (K001209) include similar applications and indications for use.

Summary of Studies:

Testing was performed to demonstrate that the design of the 4 channel 3.0T Torso Phased Array Coil meet predetermined acceptance criteria.

Conclusion:

It is the opinion of GE that the 3.0T Torso Phased Array Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T Cardiac Phased Array Coil (K971667) and USA Instruments Torso and Pelvis Phased Array Coil (K001209). Usage of the 3.0T Torso Phased Array Coil does not result in any new potential hazards.

{2}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems % Mr. Heinz Joerg Steneberg TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K030495

MAR 0 5 2003

Trade/Device Name: 3.0T Torso Phased Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 14, 2003 Received: February 19, 2003

Dear Mr. Steneberg:

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.

{3}------------------------------------------------

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

Page 2

{4}------------------------------------------------

Ko30495 510(k) Number (if known):

Device Name: 3.0T Torso Phased Array Coil

Indications For Use:

The coil is indicated for use, on the order of a physician in conjunction with a 3.0T MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.

The primary applications associated with evaluation of the anatomy are as follows:

Thorax 비
트 Abdomen
미 Male and Female Pelvis
Prostate

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Broadon

informati 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use

Regulation Number and Section

§ 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.