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ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, viewing, printing, processing, analyzing, reporting and communicating medical digital studies such as cardiac catheterization, echocardiography or general radiological studies.

ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, archiving, viewing, processing, analyzing, reporting and communicating medical digital studies such as cardiac cathetetization, echocardiography or general radiological studies.

ComPACS is a modular software device composed of different software modules operating in synergy and each responsible of different functions. The modules can be distinguished into general review station components, analysis components, reporting components, server components and gateway components.

General Review Station Components: CornPACS viewer constitutes the basic module for a review station providing viewing capabilities and retrieving capabilities from DICOM files in removable media. ComPACS Archive introduces archiving and retrieving of studies on the local review station. ComPACS Net Client allows a review station to archive and retrieve studies from a ComPACS Net Archive or from a third party DICOM compliant PACS. ComPACS Multi-Media extends ComPACS Archive to import and archive multi-media files with conversion to the DICOM format. ComPACS audio introduces digital audio management capabilities.

Analysis Components: The review station can be extended with different analysis modules. ComPACS QCA and ComPACS LVA provide respectively quantitative coronary analysis and left ventricular analysis on angiographic images. ComPACS Echocardiac, ComPACS Stress Echo provide different echo analysis features. ComPACS IVUS allows measurements and longitudinal image reconstruction on IVUS images.

Reporting Components: ComPACS Reporting allows report creation and management. This component can be further subdivided into subcomponents in relation to the different type of reports: Generic, Echocardiac, angiographic, etc. ComPACS Dictation extends the reporting module to allow for audio dictation into the report.

Server Components: ComPACS Net Archive is the basic server modules allowing and retrieving of studies from remote workstations equipped with a ComPACS Net Client module. ComPACS Security introduces user activity logging and user rights profiles management. ComPACS Storage Server provides DICOM network storage services as SCP. ComPACS Dictation Server manages the dictated reports and transfers them to an external transcription service. ComPACS Small Business Server and ComPACS Enterprise Server provide DICOM network services for small and large size networks respectively.

Gateway Components: ComPACS Recorder is a device capable of digitizing analog video signals and converting to DICOM compliant files for storage on media or network transfer to a DICOM server.

Here's a summary of the acceptance criteria and study information for the ComPACS device based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a structured table. Instead, it relies on demonstrating substantial equivalence to predicate devices. The core "acceptance criteria" presented throughout the document is that the ComPACS device is "as safe, as effective, and performs as well or better than" its legally marketed predicate devices.

Implicit Acceptance Criteria (based on substantial equivalence claims):

Study Details

The document describes non-clinical tests to demonstrate substantial equivalence, rather than a traditional comparative effectiveness study with specific endpoints like sensitivity or specificity.

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

• Sample Size: Not explicitly stated as a number of cases or images.
• Data Provenance: The document states that "image storage, query and retrieval, including DICOM network connectivity, have been tested using image sets from different imaging devices from different manufactures." This implies a diverse set of images, but no specific countries of origin or whether the data was retrospective or prospective are mentioned. The nature of the device (PACS software) suggests testing would likely involve retrospective imaging data.

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

• This information is not provided. The assessment focused on functional and technical equivalence rather than diagnostic accuracy that would typically require ground truth established by experts.

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

• This information is not provided. The non-clinical tests described focus on software functionality (e.g., DICOM compliance, image display, archival) rather than clinical accuracy adjudicated by a consensus method.

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 MRMC comparative effectiveness study was done or described. The device is a Picture Archiving and Communication System (PACS) software with analysis modules, not an AI-assisted diagnostic tool for human readers in the sense of improving their diagnostic performance. The document focuses on the device's performance and capabilities being equivalent or superior to predicate devices.

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

• Yes, in spirit. The "non-clinical tests" evaluated the ComPACS software's functionality in a standalone manner, assessing its ability to store, query, retrieve, display, and analyze images according to its specifications and in comparison to predicate device capabilities. The document asserts that ComPACS "performs as well or better than" predicate devices on its own.

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

• For the functional and technical tests described (e.g., DICOM compliance, image display, archival, processing), the "ground truth" would be the expected functional behavior and technical standards (e.g., DICOM standard compliance, successful image retrieval, correct display of image content, accurate execution of analysis algorithms). It does not appear to involve clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

• Not applicable / Not provided. The ComPACS device is a PACS system and analysis software, not a machine learning or AI algorithm that would typically require a "training set" in the context of learning from data. Its functionality is based on programmed logic and adherence to standards rather than learned patterns.

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

• Not applicable / Not provided for the same reasons as in point 8.

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In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

In-Vision View with Measurements Module supports JOMED DICOM files only. The software will not read DICOM images or loops stored using any other manufacturers' system.

In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

In-Vision View with Measurements Module provides an effective solution for physicians and interventional labs to review JOMED's In-Vision Gold digital IVUS DICOM video loops on a desktop PC or notebook. In addition, video loops and still frames can be exported to PowerPoint presentations for conferences, in-hospital training and lectures.

This document is a 510(k) summary for the In-Vision View with Measurements Module, a software device for processing medical IVUS images. It confirms the device's substantial equivalence to a predicate device, but does NOT contain information regarding acceptance criteria, study details, or ground truth establishment. The provided text primarily focuses on device description, intended use, and substantial equivalence to a predicate device (QCU ANALYTICAL SOFTWARE PACKAGE K011582).

Therefore, I cannot fulfill your request for the specific details outlined, as those details are not present in the provided text.

Based on the provided text, the following information is available:

• Device Name: In-Vision View with Measurements Module
• Manufacturer: Intelligent Images S.r.l.
• Predicate Device: QCU ANALYTICAL SOFTWARE PACKAGE (K011582) by MEDIS MEDICAL IMAGING SYSTEMS, B.V.
• Intended Use: To be used by qualified medical professionals for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive. It only supports JOMED DICOM files.
• Classification Name: System, Image Processing
• Classification Number: LLZ

The document DOES NOT provide the following requested information:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance
6. If a standalone performance study was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

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