For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resoluce scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Device Description

The SPEEDER Shoulder coil is designed for use with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the "SPEEDER Shoulder Coil." The document describes the device, its intended use, and its comparison to predicate devices, ultimately concluding its substantial equivalence.

However, a comprehensive study presenting acceptance criteria and performance data from such a study, as you've requested, is not present within the provided text.

Here's an explanation of why and what information is available:

Explanation:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. For devices like an MR coil (which is essentially a component that helps acquire images, not an AI-powered diagnostic tool), the regulatory review for substantial equivalence typically relies on:

Engineering and Safety Testing: Demonstrating that the new coil performs equivalently to the predicate coil in terms of image quality metrics (e.g., signal-to-noise ratio, uniformity, spatial resolution) and safety (e.g., heating, electromagnetic compatibility) within a controlled environment, often on phantoms and potentially healthy volunteers.
Intended Use Comparison: Showing that the intended use of the new device is the same as or very similar to the predicate device.
Material and Design Comparison: Ensuring that the materials and design choices are similar and do not introduce new risks.

The kind of detailed clinical study with acceptance criteria, ground truth, expert adjudication, and MRMC effectiveness that you've asked for is more typical for software as a medical device (SaMD) or AI-powered diagnostic tools where the algorithm itself is making a diagnostic interpretation or aiding in one.

Based on the provided text, I can answer some of your points, but most of them regarding a clinical performance study with acceptance criteria cannot be addressed:

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

Not Available. The document does not describe specific acceptance criteria for a performance study nor does it report device performance against such criteria. The focus is on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.

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

Not Applicable/Not Available. The document does not describe a clinical test set in the context of a diagnostic performance study.

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)

Not Applicable/Not Available. The document does not describe a process for establishing ground truth from expert consensus for a clinical test set.

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

Not Applicable/Not Available. The document does not describe an adjudication method for a clinical test set.

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. This device is an MR imaging coil, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant and was not performed/reported here.

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

Not Applicable. This is an MR imaging coil; it is not an algorithm that performs a standalone diagnostic function. Its performance is evaluated on its ability to produce good quality images for human interpretation.

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

Not Applicable/Not Available. For an MR coil, "ground truth" in the diagnostic sense is not typically established. Performance is usually assessed by technical parameters of image quality in comparison to a predicate device.

8. The sample size for the training set

Not Applicable/Not Available. This device does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable/Not Available. This device does not involve a "training set" or "ground truth establishment" for a training set.

Summary of what is provided in relation to your request (though not directly addressing an acceptance criteria study):

The regulatory submission (K093667) for the SPEEDER Shoulder Coil outlines:

Intended Use: "For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician." (Page 4, and Page 2 Point 9)
Predicate Devices: The device is compared to the "420 GE-64 Phased Array Shoulder Coil" (K945778) manufactured by Medical Advances Inc. (now INVIVO) and the "1.5T Atlas SPEEDER Head-Neck Coil" (K083160) by Quality Electrodynamics. (Page 2, Point 10)
Basis for Equivalence: The conclusion for substantial equivalence is based on the new coil having the same intended use, similar designs, and being constructed of similar materials as the predicate devices, with no new potential hazards. (Page 2, Point 11)

In essence, this 510(k) submission demonstrates that the SPEEDER Shoulder Coil is substantially equivalent to existing, legally marketed coils, implying that its performance is implicitly considered acceptable because the predicate devices have established safety and effectiveness. However, it does not detail a specific performance study against defined acceptance criteria in a clinical setting as would be required for a novel diagnostic algorithm.

Summary

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

K093667

510(k) . SUMMARY OF SAFETY AND EFFECTIVENESS

1. Applicant

Quality Electrodynamics (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone (440) 484-2228

2. Contact

JAN 2 8 2010

Christie Zydyk, MBA VP & GM, Regulatory Affairs, Quality Assurance, & Corporate Communications

Date prepared: 12 January 2010
Tradename

Shoulder SPEEDER Coil

5. Common name

Coil, magnetic resonance, specialty

6. Classification

21 CFR 892.1000

7. Equivalent Device

Trade name	Legally marketed predicate device	Manufacturer
SPEEDERShoulder coil	420 GE-64 Phased Array Shoulder Coil	Medical Advances Inc. (MAI, nowINVIVO)
	1.5T Atlas SPEEDER Head-Neck Coil	Quality Electrodynamics

8. Device Description

The SPEEDER Shoulder coil is designed for use with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.

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

age 2/2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

9. Intended Use

For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

10. Comparison with Predicate Devices

510(k) #	Legally marketed predicate device	Manufacturer
K945778	420 GE-64 Phased Array Shoulder Coil	Medical Advances Inc. (now INVIVO)
K083160	1.5T Atlas SPEEDER Head-Neck Coil	Quality Electrodynamics

The SPEEDER Shoulder coil and the predicate devices have intended uses as well as similar designs and are constructed of similar materials.

11. Conclusion

It is the opinion of Quality Electrodynamics that the SPEEDER Shoulder coil is substantially equivalent to the above-listed legally marketed predicate devices. Use of the Quality Electrodynamics coil does not result in any new potential hazards.

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

Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three tail feathers, representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The seal is simple and monochromatic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Quality Electrodynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 53313

JAN 2 8 2010

Re: K093667

Trade/Device Name: SPEEDER Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 13, 2009 Received: January 14, 2009

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 iddinons for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmontes, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or o 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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21c, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish finther 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 af 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 Parts 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Donald J. Trump

Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): _ K093667

Device Name: SPEEDER Shoulder coil

Indications for Use:

For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resoluce scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmes. Joff

(Division Sign Off) Division of Radiological Devices .

510(k) Number

Page 1 of 1

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.