The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).

AI/ML Overview

The provided text is a 510(k) summary for the Octave SPEEDER Spine, a magnetic resonance diagnostic device. It details the device's classification, contact information, manufacturing site, date of submission, intended use, description, safety parameters, and substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for AI/algorithm-based devices.

Here's why and what the document does provide:

Device Type: The Octave SPEEDER Spine is a receive-only phased array coil, essentially a hardware component for an MRI system. It's not an AI or algorithm-based device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.
"Acceptance Criteria" in this Context: For this type of hardware, "acceptance criteria" generally refers to meeting safety standards and demonstrating that the device functions as intended within the MRI system, and that its image quality is comparable to or better than previously cleared devices.
"Study" Information: The document refers to "testing" but not a formal study with detailed methodology, sample sizes, and expert reviews as would be expected for an AI product.

Here's a breakdown of what can be extracted or inferred based on your requested headings, with clarifications where the information is absent for an AI-focused interpretation:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance / Assessment
Safety Parameters	Maximum static field strength: 1.5 T (Matches intended use with 1.5T MR System)
	Maximum dB/dt: 1st operation mode specified in IEC60601-2-33 (2002)
	Maximum SAR: 1st operation mode specified in IEC60601-2-33 (2002)
	Peak and A-weighted Acoustic Noise Level: Not applicable
	Biocompatibility: All patient contacting materials have a history of use or test data that demonstrates its biocompatibility (non-toxic, non-irritating).
Functional / Performance	Image Quality: "Testing was conducted utilizing phantoms and accepted imaging quality metrics." "Sample phantom images and clinical images are presented in Appendix F & G." (Details of specific metrics or quantitative results are not provided in this summary.)
Substantial Equivalence	The device is claimed to be substantially equivalent to the predicate device, Atlas SPEEDER Spine [K063361]. "The new Octave SPEEDER Spine (MJAS-167A) does not change the indication for use or the intended use of the predicate device. The safety and effectiveness has been verified via risk management and application of design controls to the new Octave SPEEDER Spine." "Testing was done in accordance with applicable recognized consensus standards" (IEC60601-1, IEC60601-2, IEC60601-1-6, IEC62366, IEC60601-2-33). `Note: The "acceptance criteria" here are implicitly that its performance at least matches the predicate device for relevant parameters, and that it adheres to specified safety standards.`

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The document mentions "phantom images and clinical images" but does not give a number of phantoms or patients/cases.
Data Provenance: Not specified. "Clinical images" would imply collected data, but details like country of origin or whether it was retrospective/prospective are not present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable and not mentioned. For a hardware device like an MRI coil, "ground truth" in the context of diagnostic interpretation by experts is not the primary assessment method. Image quality is typically assessed against physical phantoms (known configurations) and qualitatively by experts for clinical utility, but not in terms of diagnostic accuracy with a "ground truth" label in the way an AI would be.

4. Adjudication method for the test set

Not applicable and not mentioned.

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 is not an AI device. No MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

No. This is not an AI device.

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

For the phantom imaging, the "ground truth" would be the known configuration of the phantom itself.
For "clinical images," image quality is likely judged subjectively by imaging specialists and objectively by predefined metrics, rather than against a specific diagnostic "ground truth" derived from pathology or outcomes, as the coil's role is to acquire the image, not to interpret it diagnostically with an automated tool.

8. The sample size for the training set

Not applicable / not mentioned. This device does not use a "training set" in the context of machine learning.

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

Not applicable / not mentioned. This device does not have a "training set."

Summary

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

K121911

Appendix A

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Classification and Device Name

Classification Name

Magnetic Resonance Diagnostic Device

Model Number

MJAS-167A

Trade/Propriety Name

Octave SPEEDER Spine

2. Establishment Registration

2020563

3. Contact Person, U.S. Agent Name and Address

Contact Person

Charlemagne Chua, Manager, Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310 e-mail: cchua@tams.com

U.S. Agent Name

Paul Biggins, Director, Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310 e-mail: pbiggins@tams.com

Address:

Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, CA 92780

4. Manufacturing Site

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

5. · Date of Submission

June 28, 2012 (revised August 3, 2012)

Device Intended Use 6.

Field Strength

1.5 T

AUG 1 7 2012

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

Resonant Nucleus

Hydrogen

Anatomical Region of Interest

Spine

Diagnostic Use

Diagnostic imaging of the thoracolumbar spine.

7. Device Description

8. Indication for use

The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.

The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

9. Design Change

The SPEEDER technology has been previously cleared under K063361 as an Atlas SPEEDER Spine coil. The primary difference is the creation of an 8ch SPEEDER Spine. The new Octave (8ch) SPEEDER Spine will use the same SPEEDER technology as other cleared SPEEDER devices.

10. Safety Parameter

Maximum static field strength

1.5 T

Maximum dB/dt

1 st operation mode specified in IEC60601-2-33 (2002)

Maximum SAR

1st operation mode specified in IEC60601-2-33 (2002)

Peak and A-weighted Acoustic Noise Level

Not applicable

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

Biocompatibility

All patient contacting materials have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating.

11. Summary of Testing

Testing was conducted utilizing phantoms and accepted imaging quality metrics.

12. Imaging Performance Parameter

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

13. Software ·

The Octave SPEEDER Spine coil does not contain software.

14. Equivalency Information

Toshiba Medical Systems Corporation believes that this Octave SPEEDER Spine is substantially equivalent to the current Atlas SPEEDER Spine [K063361]. Testing was done in accordance with applicable recognized consensus standards as listed below.

IEC60601-1 (1998), Amd1 (1991), Amd2 (1995) IEC 60601-2 (2001), Amd1 (2004) IEC60601-1-6 (2006) IEC62366 (2007) IEC60601-2-33 (2002), Amd1 (2005), Amd2 (2007)

15. Conclusion

The new Octave SPEEDER Spine (MJAS-167A) does not change the indication for use or the intended use of the predicate device. The safety and effectiveness has been verified via risk management and application of design controls to the new Octave SPEEDER Spine.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

AUG 1 7 2012

Toshiba Medical System Corporation, Japan % Mr. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K121911

Trade/Device Name: Octave SPEEDER Spine, MJAS-167A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 24, 2012 Received: July 26, 2012

Dear Mr. Biggins:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security of the device is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivalent in i referenced above and nave determined the arredicate devices marketed in interstate for use stated in the enclosue) to tegally management date of the Medical Device Amendments, or to commerce prior to May 28, 1970, the enactified in accordance with Federal Food. Drug, devices that have been reclassified in accordance will as proval application (PMA).
and Cosmetic Act (Act) that do not require approval on treasissers provisions of the Act. and Cosmetic Act (Act) that do not require approvate approvisions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, sucject success for amual registration, listing of
general controls provisions of the Act include requirements for among miskranding an general controls provisions of the receiners and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see alove) alles ones affecting your device can be found in Title 21, additional controls. Existing major Tegulations areoning John in The may publish further
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish Code of Pederal Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substitute with other requirements of the Act
that FDA has made a determination that your device with other requires. You must that FDA has made a determination und your diver Federal agencies. You must
or any Federal statutes and regulations administered by other Federal and listin or any Federal statures and regulations and including, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not ice reporti comply with all the Act s requirements, incruaing, our are cal device reporting (reporting of

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

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 800). This letter requirents as set forum in the quality by stires (<described in your Section 510(k) premated whil allow you to ocgill marketing your active quivalence of your device to a legally marketed notification. THCTDA image of succiantial value and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Parts 801 and If you desire specific anytee for your do rise as a mostic Device Evaluation and Safety at (301) 796-007), prease other 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 under the MDA regulation (21 ℃) K F art 805), prodo goblem/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 Tou may obtain 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 Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

K12)911

. .

・

Indications for Use
510(k) Number (if known):	K121911
Device Name:	Octave SPEEDER Spine, MJAS-167A
Indications for Use:

The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.

The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number	K121911
---------------	---------

Page 1 of _______

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.