The Mayo Clinic BC-10 1.5T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body which can be imaged.

Device Description

The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.

AI/ML Overview

Due to the nature of the provided document, which is a 510(k) summary for a medical device (a dedicated MRI coil), it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report comparing the performance of an AI algorithm to established acceptance criteria. Therefore, most of the requested information regarding AI algorithm performance and study methodology is not present in the document.

However, I can extract the available information related to the device's performance and the general nature of the testing mentioned.

Here's a breakdown of what can be extracted from the document:

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

The document states: "Testing was performed to demonstrate the Mayo Clinic BC-10 performed in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards." However, the specific pre-determined acceptance criteria or numerical reported device performance are not detailed in this summary. The summary focuses on comparing features to predicate devices.

Feature	Mayo Clinic BC-10 (Reported Performance - as presented in comparison)	Acceptance Criteria (Not explicitly stated numerically in this summary)
Coil Type	High-pass, quadrature, T/R	Performance in line with "high-pass, quadrature, T/R" coil characteristics for MRI applications, demonstrating safety and reliability.
Region of Interest	Small extremities < 10cm	Effective imaging of small extremities with a diameter less than 10cm, including hand, wrist, forearm, and elbow.
Compatibility	All Signa 1.5T MR systems	Compatibility with all GE Signa 1.5T MR systems.
Tuning	No external tuning necessary. Coil is optimized for small extremity anatomy.	No external tuning required, with optimized performance for small extremity anatomy.
Patient Positioning	Overhead or at patient's side	Allows for patient positioning overhead or at the patient's side.
Imaging Configuration	High SNR for small extremity imaging with 10cm FOV.	Achieves high Signal-to-Noise Ratio (SNR) for small extremity imaging within a 10cm Field of View (FOV). Specifically, to "accurately image a variety of maladies" as per indications for use.

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

This information is not provided in the 510(k) summary. The document mentions "testing was performed" and refers to "well documented clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN" but does not specify sample sizes or whether the testing was retrospective or prospective.

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)

This information is not provided in the 510(k) summary. The document describes a physical medical device (an MRI coil), not an AI algorithm requiring expert-established ground truth for its performance evaluation in that sense.

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

This information is not provided in the 510(k) summary. It's not relevant for the type of device and study described.

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

An MRMC study is not mentioned and is not relevant to this type of device (an MRI coil). The device itself is an imaging component, not an AI-powered diagnostic tool for human readers.

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

This is not applicable as the device is an MRI coil, not an AI algorithm.

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

For an MRI coil, "ground truth" would refer to the physical and electrical performance measurements of the coil, and its ability to produce diagnostically acceptable images. The implicit ground truth would be established engineering standards and clinical expectations of image quality for an MRI system. The document does not specify the exact methods for establishing this ground truth, beyond referencing "standards" and "well documented clinical, safety, and reliability data from years of use".

8. The sample size for the training set

This is not applicable as the device is an MRI coil, not an AI algorithm that undergoes a training phase.

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

This is not applicable for the reasons stated above.

In summary:

The provided document is a 510(k) summary for an MRI coil, demonstrating substantial equivalence to predicate devices based on design and general performance characteristics. It is not a study report for an AI-powered diagnostic algorithm, and as such, most of the questions related to AI study methodology cannot be answered from this text. The "study" referenced is general testing to ensure the coil met "predetermined acceptance criteria" for safety and reliability, likely involving engineering and image quality assessments, rather than evaluating AI performance against ground truth.

Summary

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Ko3 11/19 1 of 2

JUL 15 2003

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

Submitter:	Mayo Medical Ventures200 First St. SWRochester, MN 55905
Contact Person:	Jade SadostyProgram Manager
Telephone:	(507) 538-1352
Fax:	(507) 284-5410
Date Prepared:	June 18, 2003

Device Name:

Mayo Clinic BC-10 MR coil

Device Description:

The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.

Indications for Use:

Predicate Device:

The predicate devices for this coil include both the MRI Devices 1.5T phased array wrist coil and the GE Signa 1.5T birdcage, high-pass, quadrature T/R head coil.

Feature	Mayo Clinic BC-10	MRI Devices Signa 1.5T
Coil Type	High-pass, quadrature, T/R	Phased array, receive only
Region of Interest	Small extremities < 10cm	Hand and wrist
Compatibility	All Signa 1.5T MR systems	Signa 1.5T with PA option only
Tuning	No external tuning necessary.Coil is optimized for smallextremity anatomy.	No external tuning necessary.

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Patient Positioning	Overhead or at patient's side	Overhead or at patient's side
Imaging Configuration	High SNR for small extremityimaging with 10cm FOV.	High SNR for hand and wristimaging with 6cm FOV.

Summary of Studies:

Testing was performed to demonstrate the Mayo Clinic BC-10 performed in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards. Details of this testing are included in the abbreviated 510(k) submission.

Conclusions:

The results of the testing and evaluations referenced above show that the Mayo Clinic BC-10 is substantially equivalent to already approved extremity coils. It is a proven design with well documented clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, stylized with three curved lines representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 2003

Mr. Jade Sadosty Program Manager Mayo Medical Ventures 200 First Street SW ROCHESTER MN 55905 Re: K031119

Trade/Device Name: Mayo Clinic BC-10 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS

Dated: April 7, 2003 Received: April 29, 2003

Dear Mr. Sadosty:

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 (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.

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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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Page 1 of 1

510(k) Number (if known):

Mayo Clinic BC-10 1.5T Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use

David R. Segerson

(Division Sign-Of and Radiological 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.