The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.

Device Description

Picker's Quantitative Flow functionality includes the ability to create reference magnitude, phase velocity, phase contrast, phase contrast velocity and reference magnitude velocity images. The operator can define up to eight regions of interest on the phase velocity images and perform several quantitative measurements. When combined with cardiac gating, the operator can observe changes in velocity and flow throughout the cardiac cycle.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quantitative Flow device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Predicate Device K924605)	Reported Device Performance (Quantitative Flow)
Accuracy of Flow Measurements: In vivo testing demonstrated that flow could be measured to within 5.26% ± 3.77 for constant flow.	Accuracy of Flow Measurements: In vivo testing demonstrated that flow could be measured to within 3.9% ± 0.8 for constant flow.
Accuracy of Flow Measurements: In vivo testing demonstrated that flow could be measured to within 5.73% ± 3.0 for pulsatile flow.	Accuracy of Flow Measurements: In vivo testing demonstrated that flow could be measured to within 3.5% ± 2.2 for pulsatile flow.
Range of Velocities: Approx. 20-400 cm/sec	Range of Velocities: 5-600 cm/sec

Note on meeting criteria: The Quantitative Flow device exceeds the accuracy of flow measurements demonstrated by the predicate device for both constant and pulsatile flow. It also offers a wider range of measurable velocities. This "better" performance is what contributes to the substantial equivalence determination.

Study Information:

Sample size used for the test set and the data provenance:
- The document states "In vivo testing demonstrated...", implying human or animal subjects, but does not specify the sample size for this in vivo testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "In vivo testing" but does not elaborate on how ground truth was established or if experts were involved in defining it for the test results reported.
Adjudication method for the test set:
- Not specified.
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 was not an MRMC comparative effectiveness study. The comparison is between the new device's performance metrics and a predicate device's performance metrics, not human reader performance with and without AI assistance. The device is for quantitative flow measurement, not for interpretation by human readers that would be augmented by AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The reported "Accuracy of Flow Measurements" are values obtained directly from the device's measurements in an in vivo setting, indicating standalone performance. The device is an MRI option for obtaining and mapping quantitative flow, suggesting algorithmic processing of MRI data to produce these measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but implied to be a reference standard for flow measurement. For "in vivo testing," a common method for establishing ground truth for flow measurements would involve a highly accurate, independent measurement technique, or phantoms with known flow characteristics. However, the document only says "in vivo testing" without further detail on the ground truth generation.
The sample size for the training set:
- Not specified. The document does not describe the development or training of the algorithm, only its performance.
How the ground truth for the training set was established:
- Not specified. As the training set information is missing, the ground truth establishment for it is also not described.

Summary

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7 1999 SEP

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

1.	General InformationClassification:	Class IIMagnetic Resonance Imaging (MRI) System
	Common/Usual Name:	Magnetic Resonance Imaging (MRI) Option
	Proprietary Name:	Quantitative Flow
	Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143Contact: Elaine K. Keeler, Ph.DPhone: (440) 473-3000FDA Owner Number: #1580240FDA Registration Number: #1525965
	Performance Standards:	No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic Act.

2. Intended Uses

The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.

3. Device Description

4. Safety and Effectiveness

The Quantitative Flow functionality included in Picker's Application Suite for Cardiovascular Assessment is similar in technological characteristics and intended use to the GE Flow Analysis Option. The following table has been created to demonstrate their substantial equivalence.

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Parameter	Quantitative Flow	Predicate Device - GE Flow Analysis Option (K924605)
System Compatibility	1.5T Edge Eclipse and 1.0T Vista Polaris	1.5T Signa Advantage
Sequences	2D Phase Contrast, FAST	2D and 3D Phase Contrast, Cine Phase Contrast
Acquisition Options	ECG-triggered cardiac gating,PPG-triggered cardiac gating andphase encode grouping.	Flow compensation, respiratorycompensation, ECG-triggeredcardiac gating, peripheral-triggeredcardiac gating, graphic prescription,spatial presaturation, no phasewrap, rectangular FOV.
Image TypesProduced	Reference Magnitude Image, PhaseVelocity, Phase Contrast, PhaseContrast Velocity, and ReferenceMagnitude Velocity.	Magnitude, Flow and Speed Images
Range of Velocities	5-600 cm/sec	Approx. 20-400 cm/sec
Accuracy of FlowMeasurements	In vivo testing demonstrated thatflow could be measured to within$3.9% \pm 0.8$ for constant flow and$3.5% \pm 2.2$ for pulsatile flow.	In vivo testing demonstrated thatflow could be measured to within$5.26% \pm 3.77$ for constant flow and$5.73% \pm 3.0$ for pulsatile flow.
ParameterRequirements	Cine images for quantitativeanalysis can only be sensitized inone direction.	Images must be acquired in theCINE mode and the flow axis mustrepresent through-plane flow. Theslice thickness must be less than20mm.
ROI Drawing	User can manually draw up toeight ROIs for flow measurements.	User can manually draw up to fourROIs for flow measurements.
Data Output	Outputs include:- avg. velocity vs. time graph- volume vs. time graph- histogram of pixel velocities- ROI statistics (mean, STD)- Qp/Qs ratio calculations- Regurgitate volumes	Outputs include:- avg. velocity graph- avg. flow graph- ROI statistics (mean, max, min)- Flow calculations (positivevolume, negative volume,cardiac output, stroke volume)
Intended Use andIndications for Use	The intended use of QuantitativeFlow is to non-invasively obtainand map quantitative flow andvelocity measurements from avessel during a cardiac cycle usingthe principles of NMR.	The Signa Advantage Flow AnalysisOption charts flow and velocitychanges during the cardiac cycle.This post processing techniqueprovides flow information acquirednon-invasively during the cardiaccycle.

Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

(QFLOW)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 7 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re:

K992225 Quantitative Flow Dated: July 2, 1999 Received: July 2, 1999 Product Code: 90 LNH Requlatory Class: Il (two) 21.CFR 892.1000

Dear Dr. Keeler:

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 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 redassified 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 dass 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 regulation may result 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 regulations.

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 C. 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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510(k) Number (if known):

Quantitative Flow Device Name:

Indications for Use:

ﻠﻤ

The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K992225
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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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.