DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD V1.0 supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MRI data sets. DynaCAD also provides an intervention planning tool (DynaLOC) which assists with MRI guidance of percutaneous interventional procedures.

When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues. Patient management decisions should not be made based solely on the results of DynaCAD analysis.

Device Description

DynaCAD image analysis relies on the assumption that pixels having similar MRI signal intensities represent similar tissues. The DynaCAD software simultaneously analyzes the pixel signal intensities from multiple MRI sequences and applies parametric fitting methods to perform tissue segmentation and classification.

The DynaCAD system consists of proprietary software developed by MRI Devices Corporation which is installed on an off-the-shelf personal computer and a monitor configured as a DynaCAD display station.

AI/ML Overview

The provided text describes the DynaCAD V1.0, a post-processing software package for viewing and analyzing MRI studies. However, it does not contain acceptance criteria for device performance or any specific study details (like sample sizes, ground truth establishment, or expert qualifications) that would allow for a comprehensive table of acceptance criteria and reported device performance to be constructed.

The document mostly focuses on the device's intended use, general description, software development processes, and its substantial equivalence to predicate devices for regulatory approval. It mentions "Performance testing" and "Clinical Evaluation" but provides no quantitative results, acceptance thresholds, or specifics of these evaluations.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document states: - "The product has successfully completed the required integration and verification testing." - "Software beta testing also has been completed. validating that the requirements for these features have been met." - "Target accuracy was verified for the DynaLOC package in a clinical setting, using a realistic patient care procedure and placing needles in a phantom."	Not provided in the document. No quantitative metrics (e.g., accuracy, sensitivity, specificity, processing speed) or thresholds are given. The descriptions are qualitative confirmations of successful testing.

Acceptance Criteria

Reported Device Performance

Not provided in the document. The document states: - "The product has successfully completed the required integration and verification testing." - "Software beta testing also has been completed. validating that the requirements for these features have been met." - "Target accuracy was verified for the DynaLOC package in a clinical setting, using a realistic patient care procedure and placing needles in a phantom."

Not provided in the document. No quantitative metrics (e.g., accuracy, sensitivity, specificity, processing speed) or thresholds are given. The descriptions are qualitative confirmations of successful testing.

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

Sample size for test set: Not specified. The document mentions "clinical datasets" but does not quantify them.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 specified. The document indicates that a "skilled physician" interprets the device information, but it does not describe how ground truth was established for testing purposes or the specific qualifications of experts involved in such a process.

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

Not specified.

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

Not specified. The document refers to DynaCAD as a "Computer Aided Detection (CAD) system" but does not describe any MRMC studies or comparative effectiveness with or without AI assistance.

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

This is implied to some extent for the "Target accuracy was verified for the DynaLOC package in a clinical setting, using a realistic patient care procedure and placing needles in a phantom." This sounds like an evaluation of the system's ability to assist in needle placement, which would involve the algorithm's direct output. However, a formal "standalone" performance study with metrics separate from human interaction is not explicitly described or quantified. The device is generally described as a post-processing tool to be interpreted by a skilled physician, suggesting it's always human-in-the-loop.

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

For DynaLOC (intervention planning): The "target accuracy was verified... using a realistic patient care procedure and placing needles in a phantom." This implies the "ground truth" for DynaLOC's accuracy was the known target within the phantom.
For other features (segmentation, enhancement characteristics): Not specified.

8. The sample size for the training set

Not specified.

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

Not specified. The document mentions "parametric fitting methods" for tissue segmentation and classification, but not how these models were trained or how ground truth was established for any training data.

Summary

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K041286

JUL 2 1 2004

X. Summary of Safety and Effectiveness

DynaCAD V1.0

Company:

MRI Devices Corporation 1515 Paramount Drive Waukesha. WI 53186

Contact:

Thomas Tynes Manager, Interventional Business Group Phone: 262-524-1402, Ext. 129 Fax: 262-524-1403 Email: tom.tvnes@mridevices.com

Date Prepared:

17 June 2004

Name of Device

Trade Name: DynaCAD™ V1.0 Classification Name: 90 LLZ

Predicate Devices

Vital Images, Vitrea 2 (K002519) Voxar Limited, Voxar Plug n' View 3D (K992654) Acculmage, Inc., Acculmage Display Software (K961023) Mirada Solutions Ltd. Fusion 7D (K020546) Siemens Medical Solutions, Siemens BOLD MRI (K984221) GE Medical Systems. GE Advantage With FuncTool Option (K960265) Philips Medical Systems, Philips EasyVision (Quantitative Analysis Option) (K971965) Confirma, Inc., Accent (K013574) Confirma, Inc., CADstream Version 2.0 MRI Image Processing Software (K031779) 3TP, LLC, 3TP Software Option Image Processing Software for MR Devices (K031350) MRI Devices Corporation, Breast Biopsy Coil (K032576) MRI Devices Corporation, MR Biopsy (K010570)

Intended Use

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Device Description

Software Development

The DynaCAD device has been designed, developed, tested and validated according to written procedures. These procedures identify functions within the organization responsible for developing and approving product specification, coding and testing, verification and validation testing, and technical support.

Performance

The product has successfully completed the required integration and verification testing. Conformance to the DICOM standard has been achieved. Assessment of the product has been performed throughout the design development process in accordance with internal procedures and IEC 601-1-4. Risk manaqement was performed in accordance with ISO 14971.

Clinical Evaluation

Performance testing of the features described in the user manual has been successfully completed utilizing clinical datasets. Software beta testing also has been completed. validating that the requirements for these features have been met. Target accuracy was verified for the DynaLOC package in a clinical setting, using a realistic patient care procedure and placing needles in a phantom.

Substantial Equivalence

The intended use, design, and function and performance characteristics for DynaCAD are substantially equivalent to the predicate devices, particularly those from Confirma and 3TP for image analysis and from MRI Devices Corporation for MR guided breast intervention planning. It is the opinion of MRI Devices Corporation. Inc. that DynaCAD raises no new issues of safety and effectiveness as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 1 2007

Mr. Thomas E. Tynes Manager, International MRI Business Group MRI Devices Corporation, Inc. 1515 Paramount Drive WAUKESHA WI 53186

Re: K041286

Trade/Device Name: DynaCAD V1.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LLZ Dated: June 17, 2004 Received: June 18, 2004

Dear Mr. Tynes:

This letter corrects our substantially equivalent letter of July 21, 2004.

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 (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 (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); good manufacturing practice requirements as set

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Page 2 - Mr. Tynes

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 continue 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 11 you done of Compliance at (240) 276-0120 (see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your to promation nonneally (1) { 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/cdrh/dsma/dsmamain.html

Sincerely yours,

David A. Seymour

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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K041286

Statement of Indications for Use

510(k) Number (if known):

Device Name:

DynaCAD V1.0

Indications for Use:

DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD supports evaluation of dynamic MR data magination roomand maging (nistration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions such as image subtractions, multiplanar reformats, and maximum The resulting information can be displayed in a variety of formats, intensity projections. including a parametric image overlaid onto the source image. DynaCAD is designed to provide inolding a paramethe mass of visualizing the presence and pattern of contrast induced enhancements of a reliable means of vioualleng the property Aided Detection (CAD) system, DynaCAD also with data sets. In addition to boing a sol, which assists with MRI guidance of perculaneous interventional procedures.

When interpreted by a skilled physician, this device provides information that may be useful in when intervention by a online and monitoring. DynaCAD can also be used to scrooming, blughous, intervents of the diameters, areas, volumes and uptake characteristics of segmented tissues in any original, registered, analyzed or reformatted image. Patient segment decisions should not be made based solely on the results of DynaCAD analysis.

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

Over-The-Counter Use (21 CFF 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 Brogdon

(Division Sign-C Dision of Reproducti ai Radiological Devices 5 · Ak) Number

510(k) Notification MRI Devices Corporation

17 June 2004

CONFIDENTIAL page 4

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.