The Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Description

The Dynamic MRJ Software Option is a software package intended to be used with the Esaote C-scan. E-scan XO and E-scan Opera MRI systems, cleared via K040877 K032121 and K060956, respectively, The software package allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired image datasets, showing changes in image contrast over time.

It provides time intensity data, calculates the interpolation curve of the data, its maximum slope and its asymptotic value. These data, when interpreted by a trained physician, vield information that may assist diagnosis.

C-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.

E-scan XO is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and ioints. It is intended for imaging portions of the arm. including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

The C-scan, E-scan XO and E-scan Opera MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dynamic MRI Software Option for C-scan/E-scan XQ/E-scan Opera.

It's important to note that this 510(k) summary is for a software option that enhances existing MRI systems by enabling dynamic imaging and post-processing of temporal variations. The focus is on demonstrating substantial equivalence to predicate devices rather than a de novo clinical study proving novel diagnostic efficacy. Therefore, typical acceptance criteria and study designs for entirely new diagnostic algorithms might not apply directly in the same way.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this specific 510(k) is primarily centered around demonstrating substantial equivalence to predicate devices, particularly in terms of indications for use and technological characteristics, without introducing new questions of safety or effectiveness. The reported performance is essentially that the device functions comparably to the predicate devices in its ability to acquire and process dynamic MRI data to produce time-intensity curves.

Given the nature of a 510(k) for a software enhancement to an already cleared imaging system, the "acceptance criteria" are implied through comparison with predicate devices, rather than explicit numerical performance targets like sensitivity/specificity for a diagnostic AI model.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Indications for Use Equivalence: The software performs dynamic MRI data acquisition and post-processing for temporal variation display to support diagnosis.	"The Dynamic MRI Software Option for the C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis." (Matches predicate's intent)
Technological Characteristics Equivalence: Maintains similar fundamental scientific technology (pulse sequences, parameters, system components).	"The addition of the Dynamic MRI Software Option... does not alter the fundamental scientific technology of the C-scan system... E-scan XQ system... and E-scan Opera system." The comparison tables show similar pulse sequences (SET1, GE) and ranges for TR, TE, and FOV, with specific versions optimized for high acquisition speed and contrast resolution. (Substantially equivalent)
Image Processing Feature Equivalence: Provides time intensity data and curves to aid diagnosis.	"It provides time intensity data, calculates the interpolation curve of the data, its maximum slope and its asymptotic value." (Comparable to predicate's "Time intensity curves" and "Parametric images for parameters like time to peak")
Safety and Effectiveness: Does not raise new questions of safety or effectiveness compared to predicate devices, and operates within established MRI system parameters.	Implied by the 510(k) clearance itself, confirming no new safety or effectiveness concerns were identified during the review of substantial equivalence.

Study Information

Based on the provided 510(k) summary, there is no explicit clinical study described for this specific device. The clearance is based on demonstrating "substantial equivalence" to legally marketed predicate devices, which is a common pathway for modifications or enhancements to existing, cleared medical devices.

The information suggests that the device’s performance is validated through engineering comparisons to predicate devices, confirming that the new software option provides similar functionality without altering the fundamental scientific technology or raising new safety/effectiveness concerns.

Here's why specific sections of your request are not directly addressed in this type of submission:

Sample size used for the test set and the data provenance: Not applicable. No "test set" in the sense of a clinical trial dataset is described. The assessment is a comparison of technical specifications and intended use against predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" derived from expert consensus on a test set is described. The device leverages existing MRI technology, where "ground truth" is typically established by the inherent diagnostic capabilities of MRI when interpreted by a trained physician.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is mentioned.
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: Not applicable. This is not an AI-assisted diagnostic device in the modern sense, but rather a software feature for dynamic imaging. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is inherently "human-in-the-loop" as it provides data for a trained physician to interpret. It is not an autonomous diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated as part of a validation study for this specific software, as its functionality is based on established MRI principles. The "ground truth" concept is inherent in the predicate MRI systems providing diagnositc information when interpreted by a medical expert.
The sample size for the training set: Not applicable. This is not a machine learning or AI algorithm that requires a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a software feature (dynamic MRI acquisition and post-processing) for existing MRI systems. It relies on the prior clearance of its predicate devices and the established safety and effectiveness of MRI technology itself, rather than presenting a new clinical study with explicit performance metrics against a defined ground truth.

Summary

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人心儿1429

510(k) Summary C-scan/E-scan XQ/E-scan Opera Esaote S.p.A.

510(k) Summary

JUL 25 2006

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent

11460 N. Meridian St., Suite 150

Carmel, IN 46032

Phone:	(317) 569-9500 x103
Facsimile:	(317) 569-9520
Contact Person:	Carri Graham
Date:	May 22, 2006
807.92(a)(2)
Trade Name:	Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera
Common Name:	System, Nuclear Magnetic Resonance Imaging
Classification Name(s):	Magnetic Resonance Diagnostic Device
Classification Number:	90LNH
807.92(a)(3)

Predicate Device(s)

Esaote	C-scan	K040877
Esaote	E-scan XQ	K032121
Esaote	E-scan Opera	K060956
Siemens Medical Systems	Perfusion Package for Magnetom Vision and Symphony MR Systems	K984224
GE Medical Systems	Advantage Windows with FuncTool Option	K960265

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807.92(a)(4)

Device Description

807.92(a)(5)

Intended Use(s)

The Dynamic MRI Software Option for the C-scan, E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, vield information that may assist in diagnosis.

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807.92(a)(6)

Technological Characteristics

The addition of the Dynamic MRI Software Option, reflected in this 510(k), does not alter the fundamental scientific technology of the C-scan system, cleared via K040877, E-scan XQ system, cleared via K032121 and E-scan Opera system, cleared via K060956.

Characteristic	Dynamic MRISoftware Optionfor C-scan, E-scanXQ and E-scanOpera	C-scanK040877	E-scan XQK032121	E-scan OperaK990968	Comments
Pulse sequences	Spin Echo T1(SETI)Gradient Echo (GE)	Spin Echo T1(SETI)Gradient Echo (GE)	Spin Echo T1(SETI)Gradient Echo (GE)	Spin Echo T1(SETI)Gradient Echo (GE)	Unchanged
Sequenceparameters	Spin Echo 16TR from 40 ms to5000 ms, step 20 msTE fixed at 16 msminimum FOV 100mmminimum slicethickness 2 mm	SETITR from 40 ms to5000 ms, step 20 msTE from 18 ms to 34ms, step 2 msminimum FOV 100mmminimum slicethickness 2 mm	SET 1TR from 50 ms to5000 ms, step 10 msTE from 18 ms to 34ms, step 2 msminimum FOV 100mmminimum slicethickness 2 mm	SETITR from 50 ms to5000 ms, step 10 msTE from 18 ms to 34ms, step 2 msminimum FOV 100mmminimum slicethickness 2 mm	They are aparticularversion of theSpin Echo T1and GradientEcho standardsequences forobtaining highacquisitionspeed andcontrastresolution.
	Gradient Echo 6TR from 40 ms to5000 ms, step 20 msTE fixed at 6 msFA from 10° to 90°,step 5°minimum FOV 100mmminimum slicethickness 2 mm	GETR from 40 ms to5000 ms, step 20 msTE from 8 ms to 24ms, step 2 msFA from 10° to 90°,step 5°minimum FOV 100mmminimum slicethickness 2 mm	GE 10TR from 35 ms to5000 ms, step 5 msTE fixed at 10 msFA from 10° to 90°,step 5°minimum FOV 130mmminimum slicethickness 2 mm	GE 10TR from 35 ms to5000 ms, step 5 msTE fixed at 10 msFA from 10° to 90°,step 5°minimum FOV 130mmminimum slicethickness 2 mm

Substantial Equivalence Comparison Tables

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Characteristic	Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera	Perfusion package for Magnetom Vision andSymphony MR systems - K984224
Product code	LNH	LNH
Indications for use	The Dynamic MRI Software Option for the C-scan,E-scan XQ and E-scan Opera MRI Systems allowsthe acquisition of MR dynamic image datasets andthe post processing display of temporal variationsin the acquired datasets, showing changes incontrast over time. Its purpose is to provide timeintensity curves that support the diagnostic process.These images when interpreted by a trainedphysician, yield information that may assist indiagnosis.	The Perfusion Package for the Magnetom Visionand Symphony MR Systems is a softwarepackage which allows the display of temporalvariations in dynamic MR Datasets, showingchanges in contrast over time. Its purpose is toprovide either time intensity curves or thecreation of parametric images for parameters liketime to peak that support the diagnostic process.These images when interpreted by a trainedphysician, yield information that may assist indiagnosis. One clinical application where thiscould be useful is the diagnosis of lesions bytemporal analysis of tumor enhancement.
DeviceDescription	The Dynamic MRI Software Option is intended toacquire MR dynamic image datasets and uses apost processing procedure for display of temporalvariations in the acquired datasets for the C-scan,E-scan XQ and E-scan Opera MRI Systems.	The Perfusion Package is a post processingoption for the Magnetom Vision and SymphonyMR Systems
TechnologicalCharacteristics	The magnet, RF system and gradient system of C-scan, E-scan XQ and E-scan Opera MRI Systemsconfigured with the Dynamic MRI SoftwareOption is substantially equivalent to the standardC-scan, E-scan XQ and E-scan Opera Systems.	The magnet, RF system and gradient system ofthe Magnetom Vision and Symphony configuredwith the Perfusion Package is substantiallyequivalent to the standard Magnetom Vision andSymphony Systems.
Input data	Dynamic MR datasetsSingle or multi-slice datasets	Dynamic MR datasets
Features	Display of temporal variations in dynamic MRdatasets, showing changes in image contrast overtime	Display of temporal variations in dynamic MRdatasets, showing changes in image contrast overtime
Image Processing	Time intensity data and time intensity interpolationcurve, its maximum slope and its asymptotic value	Time intensity curvesParametric images for parameters like time topeak

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Characteristic	Dynamic MRI Software Option forC-scan, E-scan XQ and E-scan Opera	FuncTool OptionK960265
Product code	LNH	LLZ
Indications for use	The Dynamic MRI Software Option for theC-scan, E-scan XQ and E-scan Opera MRISystems allows the acquisition of MRdynamic image datasets and the postprocessing display of temporal variations inthe acquired datasets, showing changes incontrast over time. Its purpose is to providetime intensity curves that support thediagnostic process. These images wheninterpreted by a trained physician, yieldinformation that may assist in diagnosis.	The FuncTool option to the Advantages Windowsworkstation is a software module that providessupplemental information to those images extractedfrom CT and MR temporal datasets.
DeviceDescription	The Dynamic MRI Software Option isintended to acquire MR dynamic imagedatasets and uses a post processing procedurefor display of temporal variations in theacquired datasets for the C-scan, E-scan XQand E-scan Opera MRI Systems.	FuncTool is a functional imaging software package,which allows to display the temporal variation indynamic CT and MR datasets. Single or multi-slicedatasets, with equally spaced time interval are used forinput. The purpose is to provide Time Intensity Curvesand parametric images that provide clinical informationfor diagnosis purposes. This software is used duringpost-processing of MR and CT images on GE's CT andMR Systems.
Input data	Dynamic MR datasetsSingle or multi-slice datasets with equally ordifferently spaced time interval	Dynamic CT and MR datasetsSingle or multi-slice datasets, with equally spaced timeinterval
Features	Display of temporal variations in dynamicMR datasets, showing changes in imagecontrast over time	Display of temporal variations in dynamic CT and MRdatasets, showing changes in image contrast over time
Image Processing	Time intensity data and time intensityinterpolation curve, its maximum slope andits asymptotic value	Time intensity curves and parametric images

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 25 2006

Esaote, S.p.A. % Ms. Carri Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032

Re: K061429

Trade/Device Name: Dynamic MRI Software for C-scan, XQ and E-scan Opera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 22, 2006 Received: May 23, 2006

Dear Ms. Graham:

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.

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 Eederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/5/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary of the FDA from 1906-2006. The letters "FDA" are in a bold, sans-serif font in the center of the circle. The word "Centennial" is written in a cursive font below the letters "FDA". Three stars are centered below the word "Centennial".

noting Public G

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Page 2 -

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); 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.

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 Part 801), please contact the Office of Conipliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Kol /429

Device Name: Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Mendoza

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

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.