The Vaya MRI SYSTEM is functionally similar to most existing MRI systems. General specifications are as follows:
Magnet Subsystem
0.35 Telsa C-Shaped Compact Permanent Magnet Optimized Pole Design Homogeneity +/- 10 ppm with30 cm DSV Dimension 110cm x 160cm x 180cm Detachable Patient Table 2nd Detachable Patient Table Gradient Subsystem Strenath: 10mT/m Rise Time: 0.6ms Air Cooled RF Subsystem Quadrature Head Coil Quadrature Body/Spine Coil 3 Solenoid Coils for Extremities, Shoulder and C Spine Low Noise Preamplifier (0.5 dB Noise Figure) Digital RF Electronics Maximum Transmitter Power 5kW
Computer System
Host Computer: Dual Pentium CPU True Multi-tasking NT Environment All JAVA Language Programming RAM: 128MB Hard Disk: 2.1GB Image Capacity: 9000 256x256 1.7 GB WORM Archiving Remote System Maintenance Console Patient Registration Scanning Post-Processing & Image Enhancement (option) Display & Analysis Package Archiving User Defined Protocols User Specific Menus View Console (option) DICOM Compliant Laser Camera Interface Via 3M Protocol Laser Camera (option) CD Rewritable Drive (option) Protocols As Described on the Intended Use Page Site Requirements 5 Gauss Line 15" x 15" Maximum 3 Phase AC Power20kVA No Water Requirement

AI/ML Overview

This document is a 510(k) premarket notification for a new MRI system, the Virga™ MRI SYSTEM. It does not describe a study to prove that the device meets specific acceptance criteria in the way a clinical trial or performance validation study would for an AI/ML device.

Instead, the submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (the AIRIS II M.R.I System by Hitachi Medical Systems America, K961876, K974212, K980691). The "acceptance criteria" in this context are the regulatory requirements for showing substantial equivalence, which primarily involve comparing technical characteristics, intended use, and performance to the predicate device.

Therefore, many of the requested items (sample size, experts, ground truth type, training set details, MRMC study, standalone performance) are not applicable or not explicitly detailed in this type of regulatory submission, as it's not a study validating an AI algorithm's performance against clinical endpoints.

However, I can extract the relevant information regarding the comparison to the predicate device and the implied "acceptance criteria" for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are effectively the characteristics of the predicate device, and the "reported device performance" is how the new device compares.

FEATURE	Predicate Device (Hitachi AIRIS II MRI System) "Acceptance Criteria"	VIRGO MRI SYSTEM "Reported Performance"	Substantial Equivalence Determination (SE?)
Indications for Use	Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.	Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.	YES
Design	Open MRI	Open MRI	YES
Magnetic Field	0.30 T (Telsa)	0.35 T (Telsa)	YES (Though different, this is a technical characteristic, not a direct performance metric that would invalidate equivalence without further clinical impact)
Magnet Type	Permanent	Permanent	YES
Origin	Japan	Canada	YES (Administrative detail, not performance)
Manufacturer	Hitachi	MTI (MILLENNIUM TECHNOLOGY, INC.)	YES (Administrative detail, not performance)
Product Code	90LNH	90LNH	YES
K - Number	K961876, K974212, K980691	PENDING (at time of submission)	YES (Refers to the predicate's prior clearance)
General Controls	Complies with Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.	MILLENNIUM TECHNOLOGY, INC. intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.	YES (Implied)
Special Controls	Complies with § 1005.1 through 1005.24 and § 1005.25 for electronic products.	MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect.	YES (Implied)
Performance Standards	Utilizes various voluntary performance standards such as ASTM, ISO, QSR/CGMP, and in-house SOP standards.	MILLENNIUM TECHNOLOGY, INC. will comply with all voluntary Performance Standards applicable to MRI systems (ASTM, ISO, QSR/CGMP, and in-house SOP standards).	YES (Implied)

Summary of "Study" to Prove Acceptance Criteria:

The "study" here is the 510(k) Premarket Notification process itself, which aims to demonstrate substantial equivalence (SE) to a legally marketed predicate device. The core of this demonstration is the comparison table provided in the submission, highlighting the similarities in intended use, design, and technical specifications between the new device and the predicate.

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 Provided. This document does not describe a clinical performance study using a test set of patient data to evaluate the device's diagnostic accuracy or imaging quality. The comparison is based on the technical specifications and stated intended use of the device itself against a predicate device.

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 Provided. This document does not describe a study involving human readers or the establishment of ground truth for image interpretation.

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

Not Applicable / Not Provided. No adjudication method is described as there is no human reader study.

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 a submission for an MRI system, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or AI assistance is relevant or described.

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

No. This is not an AI algorithm. The device is a physical MRI system.

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

Not Applicable / Not Provided. For this type of 510(k) submission, the "ground truth" for showing substantial equivalence is primarily the technical specifications and regulatory clearance status of the predicate device. The new device is evaluated against these established characteristics of the predicate, not against clinical ground truth from patient data.

8. The sample size for the training set

Not Applicable / Not Provided. There is no AI model or training set described.

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

Not Applicable / Not Provided. There is no AI model or training set described.

In summary: K990153 is a 510(k) premarket notification for an MRI system, focusing on demonstrating substantial equivalence to a legally marketed predicate device (Hitachi AIRIS II). The "study" involves a feature-by-feature comparison of the new device to the predicate device to show that it is as safe and effective. It does not involve performance data from clinical trials or explicit validation against diagnostic accuracy metrics that would typically be described with acceptance criteria, sample sizes, and ground truth in the context of an AI/ML device or a novel diagnostic test.

Summary

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K990153

STILL
POINT

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

Virga™ MRI SYSTEM Trade Name:

Common Name(s): MRI System

Classification Name(s): magnetic resonance diagnostic device

2. Establishment Name & Registration Number:

Name: MILLENNIUM TECHNOLOGY, INC. Number: Pending

3. Classification:

& 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.

[53 FR 5078, Feb. 1, 1989]

Device Class: Class II Classification Panel: Radiology Devices Panel Product Code(s): 90LNH

4. Section 514 Compliance

MILLENNIUM TECHNOLOGY, INC. intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

5. Performance Standards

Food and Drug Administration mandated Performance standards MRI systems are not in effect. MILLENNIUM TECHNOLOGY, INC. will comply with all voluntary Performance Standards applicable to MRI systems. At the present time, various performance standards such as ASTM, ISO, QSR/CGMP and in-house SOP standards are used.

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6. Special Controls:

MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect, including:

(a) The provisions of § 1005.1 through 1005.24 are applicable to electronic products, which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.

(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.

Scope. The standards listed in this subchapter are prescribed pursuant to section ട്ട 1010.1 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [40 FR 32257, July 31, 1975]

4. Equivalent Predicate Device:

MILLENNIUM TECHNOLOGY, INC. believes that the Vog™ MRI SYSTEM is substantially equivalent to the following MRI system:

AIRIS II M.R.I System, K961876, K974212, K980691 by Hitachi Medical Systems 1. America.
The comparison device represents an MRI system that is functionally and technologically equivalent. Equivalency can be drawn with respect to the design, intended use, clinical utility and "open design" configuration. To facilitate comparison of the Virge™ MRI SYSTEM to the comparison system identified above, a comparison table is provided below.

5. Device Description:

The Vaya MRI SYSTEM is functionally similar to most existing MRI systems. General specifications are as follows:

Magnet Subsystem

0.35 Telsa C-Shaped Compact Permanent Magnet Optimized Pole Design Homogeneity +/- 10 ppm with30 cm DSV Dimension 110cm x 160cm x 180cm Detachable Patient Table 2nd Detachable Patient Table Gradient Subsystem Strenath: 10mT/m Rise Time: 0.6ms Air Cooled RF Subsystem Quadrature Head Coil Quadrature Body/Spine Coil 3 Solenoid Coils for Extremities, Shoulder and C Spine Low Noise Preamplifier (0.5 dB Noise Figure) Digital RF Electronics Maximum Transmitter Power 5kW

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Computer System

Host Computer: Dual Pentium CPU True Multi-tasking NT Environment All JAVA Language Programming RAM: 128MB Hard Disk: 2.1GB Image Capacity: 9000 256x256 1.7 GB WORM Archiving Remote System Maintenance Console Patient Registration Scanning Post-Processing & Image Enhancement (option) Display & Analysis Package Archiving User Defined Protocols User Specific Menus View Console (option) DICOM Compliant Laser Camera Interface Via 3M Protocol Laser Camera (option) CD Rewritable Drive (option) Protocols As Described on the Intended Use Page Site Requirements 5 Gauss Line 15" x 15" Maximum 3 Phase AC Power20kVA No Water Requirement

Applicant Name & Address: ર્ભ.

MILLENNIUM TECHNOLOGY, INC. 855 W. 12th Avenue Vancouver, B.C., Canada V5Z1M9 604.872.6039 - 604.872.0288 fax

7. Company Contact:

Regulatory Affairs MILLENNIUM TECHNOLOGY, INC. 855 W. 12th Avenue Vancouver, B.C., Canada V5Z1M9 604.872.6039 - 604.872.0288 fax

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

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9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM. Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

MILLENNIUM TECHNOLOGY. INC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act,

Special Controls: 10.

MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect, including:

(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.

ട്ട 1010.1 Scope. The standards listed in this subchapter are prescribed pursuant to section 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [40 FR 32257, July 31, 1975]

FEATURE	VIRGO MRI SYSTEM	Hitachi	SE?
Indications for Use:	Non-invasive, non-ionizing diagnostic 2D & 3D imagingsystem for use on the head, spine, torso, abdomen andextremities.	Same	YES
Design:	Open MRI	Open MRI	YES
Magnetic Field:	.35T	.30T	YES
Magnet Type:	Perm.	Perm.	YES
Origin:	Canada	Japan	YES
Manufacturer:	MTI	Hitachi	YES
Product Code:	90LNH	90LNH	YES
K - Number:	PENDING	K961876, K974212, K980691	YES

11. Summary Comparison Table:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999

Millenium Technology, Inc. C/O Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 Attn: David W. Schlerf

Re:

K990153 Virgo MRI System Dated: July 5, 1999 Received: July 23, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for ase 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in . regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Capt. Daniel G. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 - of

K 99 0153 510(k) Number :_

Virga™ MRI SYSTEM Device Name(s):

Intended Use(s) of the Device:

Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.

Diagnostic Image capabilities include:

Sagittal section images
Cross section & curved cross section images ●
Transverse section images .
Coronal section images ●
2D Fast Spin Echo ●
2D Inversion Recovery .
2D Fast Inversion Recovery ●
2D Dual Slice Acquisition ●
2D/3D Spin Echo ●
2D/3D Gradient Echo .
2D/3D Gradient Echo w/ Rephasing .
2D/3D Steady State Acquisition w/ rewind Gradient Echo (SARGE) ●
MR Angiography Image Processing ●
MR Angiography Half Echo/High Resolution High Definition ●
2D/T1/T2 Weighted Imaging ●
T1/T2 Proton Density Measurements ●

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Yamil A. Seppern
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional format 1-2-96)

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.