IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals review DICOM images by adjusting image properties, making simple measurements, and adding annotations for easy export to other applications. These features aid in postprocedure analysis after the placement of interventional devices.

Device Description

IVUS Enhancer is a software product that provides capabilities for viewing and interacting with DICOM data from Intravascular Ultrasound (IVUS) studies from all vendors, other DICOM medical image data, and INDEC echoPlaque IMG/BMG IVUS files. IVUS Enhancer's main functionality includes viewing and playback of medical images and ancillary files, minor image analysis including some measurements, and the ability to resave image cross-sections and animations to be used in future presentations.

AI/ML Overview

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

It is important to note that the provided text is a 510(k) summary for the IVUS Enhancer, which is a software product for viewing and interacting with DICOM data, performing minor image analysis and measurements, and exporting images. This type of device, being a Picture Archiving and Communication System (PACS) and an "enhancer" for existing images, primarily focuses on functional equivalence and safety rather than demonstrating improved diagnostic accuracy or clinical outcomes through rigorous clinical trials with specific acceptance criteria in the same way a novel diagnostic or therapeutic device would.

Therefore, many of the typical study elements for demonstrating performance (like specific acceptance criteria for diagnostic accuracy, MRMC studies, or large-scale ground truthing) are not present or explicitly stated in a 510(k) for this kind of software. Instead, the focus is on verification and validation activities to ensure the software performs its stated functions correctly and safely, and is substantially equivalent to predicate devices.

Based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria for device performance in the same way a diagnostic algorithm would (e.g., sensitivity, specificity thresholds). Instead, the "performance" is demonstrated by its intended use and functional capabilities being substantially equivalent to predicate devices.

Acceptance Criteria (Implied from Intended Use & Predicate Equivalence)	Reported Device Performance (Summary of Capabilities)
DICOM Image Viewing and Playback: Ability to view and play DICOM data from various vendors, including IVUS.	IVUS Enhancer provides capabilities for viewing and interacting with DICOM data from Intravascular Ultrasound (IVUS) studies from all vendors, other DICOM medical image data, and INDEC echoPlaque IMG/BMG IVUS files. Main functionality includes viewing and playback of medical images and ancillary files.
Image Interaction/Adjustment: Ability to adjust image properties.	Intended to help qualified medical professionals enhance DICOM images by adjusting image properties.
Measurements: Ability to perform minor/simple measurements.	Minor image analysis including some measurements. Intended to help qualified medical professionals make measurements.
Annotations: Ability to add annotations.	Intended to help qualified medical professionals add annotations.
Export/Resave Functionality: Ability to resave image cross-sections and animations for presentations and easy export to other applications.	The ability to resave image cross-sections and animations to be used in future presentations. Easy export to other applications.
Security/Data Integrity (Implicit for Medical Software): Handling of medical data in a safe and reliable manner.	Not explicitly detailed in the summary, but implied by regulatory requirements for medical devices.
Substantial Equivalence: Functional and performance characteristics are comparable to predicate devices.	The IVUS Enhancer is substantially equivalent in intended use, design, and operation characteristics to the In-Vision View with Measurements Module (K022940) and QCU-CMS Analytical Software Package (K011582).

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

The 510(k) summary does not provide details about a specific "test set" sample size or data provenance for performance evaluation. For software systems like this, testing usually involves verification and validation of features against functional specifications, which would use test cases rather than a "test set" of patient data for diagnostic accuracy. Since it's a PACS-like device, the focus is on handling various DICOM files correctly. We can infer that real-world or simulated DICOM data would have been used for validation, but no specifics are given.

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):

No information is provided regarding the number or qualifications of experts for establishing ground truth. For a device focused on viewing and basic measurements, "ground truth" would likely relate to the accuracy of the software's rendering or measurement algorithms, which is typically validated against known inputs or engineering specifications, rather than clinical expert consensus.

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

No adjudication method is mentioned.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic aids, not for software that primarily provides viewing, measurement, and export functionalities like the IVUS Enhancer. The device is intended to "help qualified medical professionals" by providing tools, not by making independent diagnostic assessments or providing AI-driven insights that would need to be compared against human performance.

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

The concept of "standalone performance" for this device doesn't directly apply in the way it would for an algorithm making a diagnosis. The IVUS Enhancer is explicitly designed for human-in-the-loop use ("intended to help qualified medical professionals"). Its performance pertains to its ability to correctly display images, perform measurements as specified, and export data, which are functionalities verified through software testing.

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

Given the device's function, the "ground truth" would likely be:

Known DICOM standards: Ensuring images are displayed and parameters are parsed correctly according to the standard.
Geometric accuracy: For measurements, the ground truth would be mathematically derived or based on known distances in test images/phantoms.
Functional specifications: Verification that each feature (e.g., image adjustment, annotation saving, export) performs as designed in the software requirements.
Comparison to predicate devices: Ensuring that the output and functionality are consistent with the established predicate devices.

8. The sample size for the training set:

Not applicable. The IVUS Enhancer is described as a software product providing viewing and measurement capabilities, not an AI/ML algorithm that requires a "training set" in the traditional sense. It's built on programmed logic and algorithms, not learned from data.

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

Not applicable. (See point 8).

Summary

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K062985

Image /page/0/Picture/1 description: The image shows the logo for INDEC SYSTEMS, INC. The logo includes the company name in bold, black letters. Below the company name is the address "2210 Martin Ave."

Santa Clara, CA 95050 TEL: 1 (408) 986-1600 FAX: 1 (408) 986-1605

NUV 2 2 2006

510(k) Summarv

As required by section 807.92

Submitted by: INDEC Systems. Inc. 2210 Martin Ave. Santa Clara, CA 95050

Tel: 408-986-1600 Fax: 408-986-1605

Contact Person: Carol Hubler Date: Sept 27, 2006

Device Trade Name: IVUS Enhancer Common Name: Enhancer Classification: Picture Archiving and Communication System, Class II Sec. 21 CFR 807.92

Predicate Devices:

In-Vision View with Measurements Module (K022940) QCU-CMS Analytical Software Package (K011582)

Description of the Device:

Intended Use of the Device:

IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals enhance DICOM images by adjusting image properties, making measurements, and adding annotations for easy export to other applications. These features aid in nostprocedure analysis regarding the placement of interventional devices.

Substantial Equivalence to Predicate Device:

The IVUS Enhancer is substantially equivalent in intended use, design, and operation characteristics to the following currently marketed devices:

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Intelligent Images S.r.l. (MediMatic) In-Vision View with Measurements Module (K022940),

Medis Medical Imaging Systems B.V. QCU-CMS Analytical Software Package (K011582)

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the top half, and a stylized graphic in the center. The graphic appears to be three curved lines that resemble a bird in flight or a stylized human figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Carol Hubler Vice President INDEC Systems, Inc. 2210 Martin Ave. SANTA CLARA CA 95050

NOV 2 2 2006

Re: K062985

Trade/Device Name: IVUS Enhancer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and IYO Dated: September 26, 2006 Received: October 10, 2006

Dear Ms. Hubler:

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

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial 1906-2006" arranged in a circular pattern. The letters "FDA" are prominently displayed in a bold, stylized font at the center of the logo. Three stars are located beneath the word "Centennial".

Protecting and Promoting Public Health

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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 Compliance 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Chrogdon

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): Ko6 2985

Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
(Division of
Division of
and Radiological Devices

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).