The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

Device Description

The TxRx Knee 15 Flare MR Coil 3.0T is a transmit/receive, 15-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 3.0T MR systems. The TxRx Knee 15 Flare MR Coil 3.0T is intended to be used for imaging the knee. The TxRx Knee 15 Flare MR Coil 3.0T is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a medical device called the "TxRx Knee 15 Flare MR Coil 3.0T." This document primarily focuses on demonstrating substantial equivalence to a predicate device and safety and performance characteristics for regulatory approval, rather than a detailed study for meeting specific clinical acceptance criteria of an AI-powered diagnostic device.

Therefore, many of the requested details regarding acceptance criteria, study design for AI models, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets cannot be extracted from this document. This document pertains to an MRI coil, which is a hardware component, not an AI diagnostic algorithm.

However, I can extract information related to the acceptance criteria and performance testing that were outlined for this hardware device.

Here's the information that can be extracted, and notes on what cannot be found:

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

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Comments
Biocompatibility	Safe use in cleared devices	Surface materials have a history of safe use in previously cleared devices.	This is a qualitative assessment based on material history, not a specific quantitative metric.
Electrical Safety	AAMI/ANSI ES60601-1	Found to be compliant.	Standard for medical electrical equipment.
EMC (Electromagnetic Compatibility)	IEC 60601-2-33	Found to be compliant.	Specific standard for MRI equipment.
Surface Heating	Max 41°C	Never exceeded 41°C.	Tested in accordance with AAMI/ANSI ES60601-1.
SAR (Specific Absorption Rate)	Partial body limits per IEC 60601-2-33	System controls SAR limits below IEC 60601-2-33 partial body limits.	Tested per NEMA MS-8.
SNR (Signal-to-Noise Ratio) & Uniformity	Conform to predetermined acceptance criteria per IEC 62464	Conformed to predetermined acceptance criteria.	IEC 62464 is a standard for quality control of MRI systems. The specific "predetermined acceptance criteria" are not detailed in this document.
Image Quality (Clinical)	Produce diagnostic quality images of the intended anatomy	Produced diagnostic quality images of the knee from volunteer scanning.	Assessed for "diagnostic quality" by implied interpretation, as the images "can be interpreted by a trained physician."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document mentions "clinical images from volunteer scanning of the knee" but does not specify the number of volunteers or images.
Data Provenance: Not specified, but generally, for hardware performance studies conducted by manufacturers for U.S. FDA submission, the volunteer scans would typically be prospective and likely from the manufacturer's testing facilities or affiliated sites, often within the U.S., but this is not explicitly stated.

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)

The document states that the images "can be interpreted by a trained physician," implying that qualified medical professionals would interpret the images. However, it does not specify the number of experts, their qualifications, or how a "ground truth" was established for the purpose of validating image quality. The assessment appears to be a general determination that the images are of diagnostic quality.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. There is no mention of an adjudication method as the study described is not focused on diagnostic accuracy comparisons requiring multiple expert reads and reconciliation.

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

No, an MRMC study was not done. This document describes the testing of an MRI hardware coil, not an AI-powered diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. This document concerns a hardware device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the hardware performance, the "ground truth" for image quality was based on the ability of "trained physicians" to interpret the images for diagnostic purposes. This is a form of expert assessment of image utility, but not a formal "ground truth" in the sense of a definitive diagnosis (e.g., pathology report) against which a diagnostic algorithm would be measured.

8. The sample size for the training set

Not applicable/Not specified. This document is about a hardware device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not specified. As there is no AI algorithm being described, there is no training set or ground truth establishment for such a set.

Summary

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Image /page/0/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 29, 2016

Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 6655 Beta Drive. Suite 100 MAYFIELD VILLAGE OH 44143

Re: K163066

Trade/Device Name: TxRx Knee 15 Flare MR Coil 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 31, 2016 Received: November 2, 2016

Dear Ms. Aras:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163066

Device Name TxRx Knee 15 Flare MR Coil 3.0T

Indications for Use (Describe)

The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

1. Applicant

Quality Electrodynamics, LLC. (QED) 6655 Beta Drive, Suite 100 Mayfield Village, OH 44143

2. Contact

Kathleen Aras Director, Regulatory and Quality Affairs (440) 484-2964 kathleen.aras@qualedyn.com

3. Date Prepared

31 October 2016

4. Tradenames

TxRx Knee 15 Flare MR Coil 3.0T

5. Common name

Coil, magnetic resonance, specialty

Model Numbers 6.

QED Model Number: Q7000168

7. Classification

Magnetic resonance diagnostic device (21 CFR 892.1000, Product Code MOS, Class II)

8. Unmodified Device

3.0T TxRx 15Ch Knee Coil, Quality Electrodynamics, LLC., K082636

9. Device Description

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The TxRx Knee 15 Flare MR Coil 3.0T is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.

10. Indications for Use

The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

The Indications for Use statement for the modified TxRx Knee 15 Flare MR Coil 3.0T is not identical to the unmodified device (3.0T TxRx 15Ch Knee Coil); however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the unmodified device. Both Indications for Use statements for the modified TxRx Knee 15 Flare MR Coil 3.0T and unmodified 3.0T TxRx 15Ch Knee Coil indicate that the device is intended to be used in conjunction with a 3.0T MR system to produce images of the knee and that the images can be interpreted by a trained physician.

11. Summary of Technological Characteristics Compared to the Unmodified Device

At a high level, the modified device and unmodified device are based on the following same technological elements:

. Transmit/receive phased array RF coils
Active PIN diode switching blocking circuitry. Passive blocking . circuitry.
Split-top mechanical design with an inner cross section shaped to fit . the knee and leg
. Polycarbonate housing material

The following technological differences exist between the modified device and unmodified device:

Changes to ergonomics of patient-user interface such as modified . system cable connector and the use of one system cable (modified device) in comparison to two system cables (unmodified device)
Changes to dimensional specifications of the mechanical design of the . enclosure

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12. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

All surface materials on the TxRx Knee 15 Flare MR Coil 3.0T that are intended to come into direct or indirect contact with patient biological tissues, cells or body fluids have a history of safe use in previouslycleared devices.

Electrical Safety and Electromagnetic Compatibility

The TxRx Knee 15 Flare MR Coil 3.0T was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.

Surface heating was tested in accordance with AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41°C.

SAR measurement testing was performed per NEMA MS-8 to provide data supporting that the partial body limits for SAR are controlled within the limits described in IEC 60601-2-33. The testing showed that the system controls the SAR limits for the TxRx Knee 15 Flare MR Coil 3.0T such that they remain below the IEC 60601-2-33 partial body limits.

Performance Testing - Bench

The SNR and uniformity of the TxRx Knee 15 Flare MR Coil 3.0T was analyzed per IEC 62464 and was found to conform to predetermined acceptance criteria.

Performance Testing - Clinical

In accordance with the FDA Guidance for Industry: Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of the knee were obtained from the TxRx Knee 15 Flare MR Coil 3.0T. These images were used to demonstrate that the TxRx Knee 15 Flare MR Coil 3.0T produces diagnostic quality images of the intended anatomy.

13. Conclusion

The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the TxRx Knee 15 Flare MR

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Coil 3.0T and the bench testing per the IEC standards and diagnostic quality sample clinical images demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the TxRx Knee 15 Flare MR Coil 3.0T performs as well as or better than the unmodified device.

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.