The QD KNEE/FOOT COll. is comprised of coil element and PC board. The coil element shapes STIR type coil. The PC board switches transmit mode and receive mode with PIN diodes and combines the NMR signals.

The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "QD KNEE/FOOT COIL." It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical study for an AI/ML medical device would.

This document is a premarket notification for a hardware accessory (an MRI coil) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than performance against a set of quantitative acceptance criteria in a study. The information provided is about the device's technical specifications and intended use.

Therefore, many of the requested categories cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document doesn't outline specific "acceptance criteria" in the sense of predefined thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) that an AI device would need to meet. Instead, it details safety parameters and imaging performance parameters, which are more akin to technical specifications for the hardware. The "reported device performance" is largely qualitative, referring to sample images.

Parameter	Acceptance Criteria (Implicit/Stated)	Reported Device Performance
Safety Parameters
Maximum static field strength	1.5 Tesla (This is a specification of the compatible MRI system, not the coil's intrinsic performance, but implies it must operate safely at this field strength)	N/A (The coil is designed for a system with this field strength)
Rate of change of magnetic field	30 mT/second (Maximum safe rate of change for the compatible MRI system)	N/A
Maximum radio frequency power deposition (SAR)	< 4.8 watt/kg (Maximum safe SAR for the compatible MRI system during operation with the coil)	N/A
Acoustic noise levels (maximum)	110 dB(A-weighted) (Maximum safe acoustic noise level for the compatible MRI system during operation with the coil)	N/A
Imaging Performance Parameters
Specification volume	15 cm dsv (This describes the desired effective imaging volume of the coil)	"Sample phantom images and clinical images are presented in Appendix F & G." (Qualitative demonstration of imaging capability within the specified volume)
Anatomical regions	Knee, ankle and foot regions (Intended use regions)	Imaging of these regions is intended and demonstrated qualitatively.
Nuclei excited	Hydrogen (Standard for clinical MRI)	N/A
Diagnostic Use	Diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy (Intended diagnostic capabilities)	Images are shown to support these capabilities.

Regarding the study that proves the device meets the acceptance criteria, and further details you requested:

The provided document is a 510(k) summary for a hardware device, not an AI/ML diagnostic system. Therefore, it does not contain information on the following as these concepts are not applicable to this type of submission:

Sample size used for the test set and the data provenance: Not applicable. The "study" here is primarily demonstrating technical specifications and substantial equivalence, not clinical diagnostic performance on a specific dataset. "Sample images" are mentioned but not described as a formal test set for statistical analysis.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance isn't established for this hardware accessory.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a hardware device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
How the ground truth for the training set was established: Not applicable.

Summary based on the document:

The QD Knee/Foot Coil demonstrated its technical specifications and performance through phantom and clinical images, which were presented in confidential appendices (F & G) to the FDA. The primary "proof" of meeting safety and effectiveness involves demonstrating that the device adheres to MRI safety standards and provides images suitable for its stated diagnostic uses, and is substantially equivalent to a previously cleared predicate device (QD Knee coil, K032490). The "study" refers to the engineering and testing that confirmed the specified parameters and image quality, rather than a clinical trial with statistical performance metrics on a patient cohort that would be relevant for an AI/ML device.

Summary

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JUL 1 4 2005

1051763

Appendix A

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

DEVICE NAME 1. Magnetic Resonance Diagnostic Device Accessory Model Number MJQJ-147A Trade/Proprietary Name QD KNEE/FOOT COIL™
1. ESTABLISHMENT REGISTRATION 2020563
1. U.S. AGENT NAME AND ADDRESS Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle DriveTustin, CA 92780

CONTACT PERSON

Michaela Mahl (714) 730-5000

MANUFACTURING SITE 4.

Toshiba Medical Systems Corporation (TMSC) 1385, Shimoishigami, Otawara-Shi, Tochigi 324-8550, Japan

5. DATE OF SUBMISSION

June 16, 2005

6. DEVICE DESCRIPTION

The QD KNEE/FOOT COIL is QD volume coil that can transmit RF and receive NMR signal from like the knee or other extremity regions.

The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.

7. SAFETY PARAMETERS

Maximum static field strength Rate of change of magnetic field Maximum radio frequency power deposition (SAR) Acoustic noise levels (maximum)

1.5 Tesla 30 mT/second < 4.8 watt/kg 110 dB(A-weighted)

8. IMAGING PERFORMANCE PARAMETERS

Specification volume

15 cm dsv

Sample phantom images and clinical images are presented in Appendix F & G.

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INTENDED USE 9.

Anatomical regions Nuclei excited Diagnostic use

Knee, ankle and foot regions Hydrogen Diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy

10. EQUIVALENCY INFORMATION

Toshiba Medical Systems Corporation believes that this QD Knee/Foot coil is substantially equivalent to the current QD Knee coil (K032490).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Public Health Service

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 1394 25th Street NW BUFFALO MN 55313

Re: K051763 Trade/Device Name: QD Knee/Foot Coil for Vantage MRI System (MRT-1503) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 28, 2005 Received: June 30, 2005

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 (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 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 (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.

JUL 1 4 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his leter will anow you to ogen manises of your device of your device to a legally premaired notheation: "The PDF mailing of Survice and thus, permits 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 If you desire specific advice for your de 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" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain outer general 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/industry/support/index.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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Page 1 _______________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):	K051763
Device Name:	QD Knee/Foot Coil for Vantage MRI System (MRT-1503)
Indications for Use:

Imaging of:

Diagnostic imaging of the knee, ankle and foot regions
Fluid visualization
2D and 3D imaging
2D and 3D imaging .
MR angiography .
MR fluoroscopy .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
✓

Over-The-Counter Use _

(Optional Format 1-2-96)

Nancy C. Brogdon

(Dıvision Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 1051 165 510(k) Number _

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.