The Atlas SPEEDER Head/Neck is intended for use with Toshiba 3T MR systems to produce diagnostic images of the head, neck, and feet that can be interpreted by a trained physician.

Device Description

The Atlas SPEEDER Head/Neck is a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 3T MR systems. The Atlas SPEEDER Head/Neck is intended to be used for imaging the head, neck, and feet.

The Atlas SPEEDER Head/Neck 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 is biocompatible.

The Atlas SPEEDER Head/Neck includes one posterior section and three anterior pieces, a neurovascular (NV) adaptor used for head, brain, and neurovascular imaging, a cervical spine (C-spine) adaptor used for neck and cervical spine imaging, and a base adaptor used when claustrophobia or space contraints are an imaging issue.

The Atlas SPEEDER Head/Neck also includes the accessories listed in Table 0-1. The accessories consist of pads, straps, a mirror and a phantom holder.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Atlas SPEEDER Head/Neck." The document focuses on demonstrating substantial equivalence to a predicate device and provides information on various tests conducted. However, it does not explicitly state acceptance criteria in a table format alongside specific device performance values for quantitative measures (like SNR thresholds, spatial resolution, etc.) that would typically be used to justify acceptance.

The document discusses "pre-determined acceptance criteria" for SNR and uniformity in the bench testing section, but does not detail what those criteria are or the precise reported performance values against them. Similarly, for clinical imaging, it states the device produces "diagnostic quality images" without outlining the specific criteria for this quality or how it was assessed quantitatively.

Therefore, many of the requested details, especially those pertaining to a detailed acceptance criteria table, MRMC studies, specific effect sizes, and detailed ground truth procedures for clinical performance, are not explicitly present in the provided text.

Based on the available information, here is a description of the acceptance criteria and study details:

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

Acceptance Criteria Category	Acceptance Criteria (as implied or stated in document)	Reported Device Performance (as stated in document)
Biocompatibility	Compliance with ISO 10993-1, -5, -10 standards.	All patient-contacting materials either have a history of safe use or were tested for cytotoxicity, irritation, and sensitization per ISO 10993, and were found to be compliant.
Electrical Safety	Compliance with AAMI/ANSI ES60601-1.	Device was tested and found to be compliant with AAMI/ANSI ES60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-2-33.	Device was tested and found to be compliant with IEC 60601-2-33.
Surface Heating	Maximum surface temperature not to exceed 41°C.	The measured temperature of the surface of the coil never exceeded 41°C.
Signal-to-Noise Ratio (SNR)	Conformance to "pre-determined acceptance criteria" per NEMA MS 6-2008.	Found to conform to pre-determined acceptance criteria. (Specific values not provided)
Image Uniformity	Conformance to "pre-determined acceptance criteria" per NEMA MS 6-2008.	Found to conform to pre-determined acceptance criteria. (Specific values not provided)
Clinical Diagnostic Quality	Production of "diagnostic quality images" for intended anatomies.	Produced diagnostic quality images of the head, neck, and feet. (Specific criteria for "diagnostic quality" not provided)

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

The document mentions "clinical images from volunteer scanning of the head, neck and feet were obtained." However, it does not specify:

The exact sample size (number of volunteers or scans) used for this clinical performance testing.
The country of origin of the data.
Whether the study was retrospective or prospective, though "volunteer scanning" implies a prospective 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)

The document states that images "can be interpreted by a trained physician" but does not specify:

The number of experts involved in assessing the diagnostic quality of the images.
Their specific qualifications or experience levels.
If a formal ground truth establishment process involving experts for the clinical images was conducted as part of the submission, beyond the general statement of diagnostic quality.

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

The document does not mention any specific adjudication method used for the clinical performance images.

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 MRMC study appears to have been done or reported. The device is a receive-only coil for an MR system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system. Therefore, the concept of human readers improving with AI assistance is not applicable to this device type.

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

This question is not applicable as the device is an MRI coil, not an algorithmic diagnostic tool. Its performance is evaluated on its ability to produce raw diagnostic images, which are then interpreted by a human physician.

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

For the "Clinical Diagnostic Quality" assessment, the implicit ground truth is expert interpretation (a "trained physician" interpreting the images). However, the document does not detail how this "diagnostic quality" was formally established or measured beyond this general statement. There is no mention of pathology or outcomes data being used to establish ground truth for image diagnostic quality.

8. The sample size for the training set

This question is not applicable as the device is a hardware component (MRI coil), not a machine learning model that requires a training set. The performance data is based on bench tests and clinical image acquisition.

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

This question is not applicable as there is no training set for this hardware device.

Summary

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

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

July 29, 2015

Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143

Re: K151829

Trade/Device Name: Atlas SPEEDER Head/Neck Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 2, 2015 Received: July 6, 2015

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.

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

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.

For

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

Enclosure

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

Indications for Use

510(k) Number (if known) K151829

Device Name Atlas SPEEDER Head/Neck

Indications for Use (Describe)

The Atlas SPEEDER Head/Neck is intended for use with Toshiba 3T MR systems to produce diagnostic images of the head, neck, and feet 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

1. Applicant

Quality Electrodynamics, LLC. (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143

2. Contact

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

Date Prepared 3.

2 July 2015

4. Tradenames

Atlas SPEEDER Head/Neck

5. Common name

Coil, magnetic resonance, specialty

6. Model Numbers

QED Model Number: Q7000146

Toshiba Model Number: MJAH-172A

This device is manufactured and sold by QED to Toshiba. Toshiba sells the device to end users under their own model number.

7. Classification

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

8. Predicate Device

Atlas SPEEDER Head-Neck, Quality Electrodynamics, LLC., K142802

No reference devices were used in this submission.

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

9. Device Description

The Atlas SPEEDER Head/Neck also includes the accessories listed in Table 0-1. The accessories consist of pads, straps, a mirror and a phantom holder.

QED Part Number	Description	Qty
3003150	SHOULDER PAD	1
3003152	NECK PAD	1
3003153	10 DEGREE TILT PAD	1
3003154	20 DEGREE TILT PAD	1
3003486	ACR PHANTOM HOLDER	1
3003685	HEAD PAD THICK	1
3003686	HEAD PAD THIN	1
3003813	25MM TAPERED PAD	2
3003814	40MM TAPERED PAD	2
3003579	COMBO PAD	1
3003649	COMBO PAD STRAP LEFT	2
3003683	COMBO PAD STRAP RIGHT	2
2001171	MIRROR ASSEMBLY	1

Table 0-1: Atlas SPEEDER Head/Neck Accessories

10. Indications for Use

The Atlas SPEEDER Head/Neck is intended for use with Toshiba 3T MR systems to produce diagnostic images of the head, neck, and feet that can be interpreted by a trained physician.

{5}------------------------------------------------

The Indications for Use statement for the Atlas SPEEDER Head/Neck is not identical to the predicate device; 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 predicate. Both Indications for Use statements indicate that the device is intended to be used in conjuction with an MR system to produce images of the head, neck and feet and that the images can be interpreted by a trained physician. The Indications for Use statements differ in that the proposed Atlas SPEEDER Head/Neck is intended for use in a 3T MR system versus 1.5T MR system for the predicate device.

11. Summary of Technological Characteristics Compared to the Predicate Device

The proposed Atlas SPEEDER Head/Neck and the predicate Atlas SPEEDER Head/Neck are both 16-channel, receive-only, phased array RF coils intended to be used in conjunction with an MR system to provide images of the head, neck and feet and that the images can be interpreted by a trained physician.

At a high level, the subject and predicate devices are based on the following same technological elements:

. 16-channel, receive-only, 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 head
Three anterior adaptors included ●
Housing materials are rigid, fire-rated, and biocompatible

The following technological differences exist between the subject and predicate devices:

Field strength of MR system (3T (subject) versus 1.5T (predicate)) .

12. Performance Data

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

{6}------------------------------------------------

Biocompatibility Testinq

All surface materials on the Atlas SPEEDER Head/Neck and its accessories that are intended to come into direct or indirect contact with patient biological tissues, cells or body fluids either have a history of safe use in previously-cleared devices or have been assessed for biocompatibility according to ISO 10993-1. Per ISO 10993-1, all patientcontacting materials on the 16ch Tx/Rx Knee SPEEDER are classified as surface-contacting, limited exposure (A) devices. Therefore, where testing was performed, the materials were tested for cytotoxicity per ISO 10993-5 and for irritation and sensitization per ISO 10993-10.

Electrical Safety and Electromagnetic Compatibility

The Atlas SPEEDER Head/Neck 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

Performance Testing - Bench

The SNR and uniformity of the Atlas SPEEDER Head/Neck was analyzed per NEMA MS 6-2008 and was found to conform to pre-determined 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 head, neck and feet were obtained from the Atlas SPEEDER Head/Neck. These images were used to demonstrate that the Atlas SPEEDER Head/Neck produces diagnostic quality images of the intended anatomies.

13. Conclusion

The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the Atlas SPEEDER Head/Neck and the bench testing per the NEMA standards demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the Atlas SPEEDER Head/Neck performs as well as or better than the predicate 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.