ImageFusion 2.0, aids in identification of brain tumors prior to radiotherapy or stereotactic neurosurgical treatment planning. ImageFusion 2.0 has been enhanced to allow fusion of MR/MR images, in addition to CT/CT and CT/MR fusions that the previous version was capable of performing. The fusion process is based on the matching of bone or intensity and does not rely on matching of stereotactic rods or image slices. Therefore, a non-stereotactic MR or CT image can be re-sampled according to the stereotactic coordinates of the reference CT or MR image and further used in a stereotactic capacity.

ImageFusion 2.0 is image registration software for fusing a pair of 3D image sets. Both the reference and secondary image sets can be CT or MR images. The MR scans can be T1-weighted or non T1-weighted.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for ImageFusion 2.0:

The provided 510(k) summary for ImageFusion 2.0 is quite succinct regarding the depth of performance testing. It focuses on verifying the accuracy of image registration and the functionality of key features.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary: Accurate registration of MR images in stereotactic CT space.	Average Accuracy: Approximately 1.7 mm for landmark registration.
Primary: Maximum accuracy for individual landmarks during MR image registration in stereotactic CT space.	Maximum Accuracy: Approximately 2.9 mm for individual landmarks.
Secondary (System & Unit Testing): Bone segmentation accuracy	Verified to be accurate through system and unit testing.
Secondary (System & Unit Testing): Intensity match accuracy	Verified to be accurate through system and unit testing.
Secondary (System & Unit Testing): Landmark alignment accuracy	Verified to be accurate through system and unit testing.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., number of patient images, type of images, country of origin, retrospective/prospective). It only refers to "system testing" and "unit testing" without providing these details.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The accuracy metrics (1.7 mm on average, 2.9 mm maximum) imply a quantitative measurement, but the method of establishing the "true" registration for comparison is not detailed.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case comparative effectiveness study was not conducted or reported. The device is a "pre-processing registration tool" and its performance is measured in terms of registration accuracy, not its impact on human reader performance.

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

Yes, the reported performance appears to be a standalone (algorithm only) assessment of the ImageFusion 2.0 system's ability to register images. The mentioned accuracy figures (1.7 mm on average, 2.9 mm maximum) are for the device's output itself.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. The accuracy metrics (mm) suggest that the ground truth for registration was likely established through a method that allows for quantitative comparison of spatial alignment, perhaps manual landmark identification by experts or a gold-standard registration method. It's not stated if it's based on pathology or outcomes data.

8. The sample size for the training set

The document does not provide any information about the sample size used for the training set.

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

The document does not provide any information on how the ground truth for the training set was established. Given the age of the submission (1999) and the nature of the device, it's possible that the "training" (development and refinement) of the algorithms for bone segmentation, intensity match, and landmark alignment was done using internal development data or established image processing techniques rather than a formal, large-scale supervised learning approach with explicitly defined ground truth for a training set.

Summary

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

K990071

ImageFusion 2.0 - 510(k) Summary

This Summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 8807.92.

Submitter of Premarket Notification:

Nancy MacDonald Sr. Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Ave. Burlington, MA 01803 Telephone: (781) 272-1233, ext. 296 Fax: (781) 272-2428

Establishment Registration Number: 1222895

Performance Standards: None established under Section 514.

This summary was prepared on January 6, 1999.

Device Name: ImageFusion 2.0

Common Name: Image Correlation System

Safety Summary:

Radionics Software Applications' ImageFusion 2.0 system testing verifies that the registration of MR images in stereotactic CT space is accurate and is approximately 1.7 mm on average and 2.9 mm maximum for individual landmarks. Further, system and unit testing verify that features such as bone segmentation, intensity match and landmark alignment, which form the basis of a fusion session, are accurate.

Predicate Device:

ImageFusion System: 510(k) number K960071, dated April 17, 1996.

Intended Use:

The intended use for ImageFusion 2.0 is: A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.

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

ImageFusion 2.0 510(k) Summary _ cont.

Device Description:

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is oriented towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 FEB

Nancy C. MacDonald Senior Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803-2516

Re:

K990071

ImageFusion 2.0 Dated: January 8, 1999 Received: January 11, 1999 Regulatory class; II 21 CFR 892.5050/Procode: 90 MUJ

Dear Ms. MacDonald:

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 manteed production as now the energes that have been reciassified 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of be dayse to outlieral controlly Extrans. 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 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

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

510(k) Number (if known):

Device Name: ImageFusion 2.0

Indications for use:

A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109

Over-The-Counter Use __
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990071

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.