IMMERGE IMAGE CORRELATION by SURGICAL NAVIGATION TECHNOLOGIES, INC.

The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.

Device Description

image correlation system

AI/ML Overview

This 510(k) summary does not contain the typical level of detail required to thoroughly describe the acceptance criteria and the study proving the device meets them. This document is a very high-level summary that primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the provided text, here's what can be extracted and what information is missing:

Acceptance Criteria and Study Details (Based on K991468 510(k) Summary)

The provided 510(k) summary for the ImMerge™ Image Correlation System Version 2.0 is highly condensed and focuses on demonstrating substantial equivalence to a predicate device (ImMerge V1.0, K970623). As such, it does not explicitly state specific quantitative acceptance criteria or detailed study results for device performance. The primary "proof" of meeting criteria in this type of submission is the demonstration that the modified device performs "the same as or similar to" the predicate device for its intended use.

Here's a breakdown of the requested information, indicating what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided document.	Not explicitly stated in the provided document. The document implies that the device achieved "precise spatial registration" similar to its predicate. The key assertion is that the "technological characteristics are the same as or similar to those found with the predicate device."

Missing Information: Specific quantitative metrics for "precise spatial registration" (e.g., target registration error, spatial accuracy thresholds) are not provided. There are no performance results like sensitivity, specificity, accuracy, or specific error rates.

2. Sample Size Used for the Test Set and Data Providence

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Missing Information: The number of cases, images, or subjects used to evaluate the automatic image correlation feature are not mentioned.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Missing Information: There is no mention of experts being involved in establishing a ground truth for any test set or how their qualifications were assessed.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.
Missing Information: Given the lack of a defined test set and experts, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No, this type of study is not mentioned or described in the summary.
Effect Size (AI vs. without AI): Not applicable, as no MRMC study is reported.
Missing Information: MRMC studies are generally more recent requirements or for devices with a higher potential impact on interpretation. This older 510(k) summary is unlikely to include such a study.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done: Not explicitly stated as a separate, formal "standalone" study with specific metrics. However, the update is to provide an "automatic first attempt at image correlation," implying the algorithm's standalone function is what was modified and likely tested. The overall 510(k) process for this device type typically involves verifying that the algorithm itself performs as intended without human intervention for the automated task.
Missing Information: While the function is "automatic," specific quantitative results or a dedicated standalone performance study with detailed metrics are not provided.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For image correlation systems, ground truth often involves fiducial markers in phantoms, manually registered images by experts, or known anatomical landmarks.
Missing Information: The method for establishing the true, correct registration is not described.

8. Sample Size for the Training Set

Sample Size (Training Set): Not specified.
Missing Information: This 510(k) predates the common emphasis on deep learning and large-scale training sets for medical devices. If machine learning was used at all (unlikely for "V2.0" in 1999 to the extent seen today), the size of any training data would not typically be disclosed in such a summary from that era.

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: Not specified.
Missing Information: Similar to point 8, this detail would not typically be found in a 510(k) summary from 1999, especially without explicit mention of machine learning.

Summary of the Document's Information:

The 510(k) summary for the ImMerge™ Image Correlation System Version 2.0 serves to demonstrate substantial equivalence to an earlier version (V1.0, K970623). The "study" referenced implicitly is the comparative analysis showing that the updated device, with its new "automatic first attempt at image correlation" feature, maintains the same or similar technological characteristics and performs comparably to the predicate device for its intended use of precise spatial registration for diagnosis and treatment planning. The document lacks specific quantitative performance data, sample sizes, expert involvement details, or ground truth methodologies that are common in more recent and detailed clinical study reports.

Summary

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510(k) Summary

K991468

Date Prepared: May 6, 1999

I. Submitter Information:
Contact: Angelique Destruel Clinical and Regulatory Affairs Associate Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
Trade name: ImMerge™ Image Correlation System Version 2.0; II. Common or usual name: image correlation system; Classification name: image processing system
III. The above device is substanitally equivalent to the ImMerge V1.0 Image Correlation System (K970623). Evidence of the substantial equivalence was provided.
This submission describes updates made to the ImMerge™ System to provide an IV. automatic first attempt at image correlation. The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, and radiotherapy.
V. The device like its predicates is intended for use in cranial surgery, radiosurgery and radiotherapy procedures
VI. The technological charecteristics are the same as or similar to those found with the predicate device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three parallel lines forming a shape reminiscent of a bird or abstract human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 1999

Roger White Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020

Re:

K991468 ImMerge Image Correlation System V2.0 Dated: April 26, 1999 Received: April 27, 1999 Regulatory Class: II 21 CFR 892.2050/procode: 90 LLZ

Dear Mr. White:

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 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 requlation 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,

BART D. Golding, 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): _

ImMerge™ Image Correlation System Version 2.0 Device Name: . . .

Indications For Use:

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

David A. Syverson

Reproductive, Abdominal, 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).