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The TouchPACS Suite software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non- DICOM information and data management system. The TouchPACS Suite PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shell" personal computers, business computers, and servers running standard operating systems. TouchPACS TouchMGR Suite DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from any OEM modality which support DICOM standard imaging data. The system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements.

The TouchPACS Suite software is not for mammographic use.

The TMS TouchPACS Suite is a collection of software applications coded in the Microsoft C# application language, using the Windows Presentation Foundation (WPF) libraries for user interface, that run on "off-the-shelf" Microsoft Windows-based personal or business computers to provide diagnostic imaging workstation capabilities. The system is designed to provide an environment for radiological diagnosticians which is "easy on the eyes"; so that the user can use the system for 10-12 hours per day without undue strain.

The core of the system is the database, which is a relational design, using Microsoft SQL Server 2008 Enterprise edition as the Relational Database Management System (RDBMS). The database server provides a dedicated, central place to provide disaster recovery servicing (via standard SQL Server replication), as well as the large multiterabyte storage required for a PACS system.

Attached to the RDBMS are TouchPACS client workstations, TouchMGR client workstations, and servers required for system operations: TMS DICOM SCP Server and Microsoft SQL Server. All of the aforementioned software modules, except for Microsoft SQL Server, are TMS software products.

The TouchPACS Suite PACS client workstation is intended to be a desktop computer replacement product, with the interface dominating the screen space on a workstation computer.

The TouchMGR client workstation represents the nerve center of the TouchPACS Suite, providing services for securing the TMS network, maintaining users, allowing paperless workflow, and other such critical day-to-day system maintenance tasks.

The TMS DICOM SCP Server provides multi-threaded DICOM v3 server capabilities of the TouchPACS system.

The provided text describes a 510(k) summary for the "TouchPACS Suite," a medical imaging workstation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative form (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, it relies on demonstrating that the TouchPACS Suite has similar intended use and technical features to its predicate devices. The "Predicate Device Comparison" table highlights feature parity rather than performance metrics.

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

Not applicable. The document describes a comparison to predicate devices based on features and functionality, not a performance study on a test set of medical images.

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

Not applicable. Ground truth establishment for a diagnostic performance study is not described.

4. Adjudication method for the test set

Not applicable. No test set adjudication method is described.

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 study or any study on human reader improvement with AI assistance is mentioned. The device is a PACS system, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a PACS system and viewer, not a standalone algorithm with diagnostic performance metrics. Its functionality is to store, display, and manipulate images for human interpretation.

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

Not applicable. No ground truth is mentioned as this is not a diagnostic performance study. The focus is on DICOM compliance, feature parity with predicate devices, and general software functionality.

8. The sample size for the training set

Not applicable. There is no mention of a training set as the device is a PACS system, not a machine learning model.

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

Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of Acceptance Criteria and Study Details (Based on the Provided Text):

The "acceptance criteria" for the TouchPACS Suite, as presented in this 510(k) summary, are primarily based on achieving substantial equivalence to existing legally marketed predicate devices. This is demonstrated by showing that the device has:

• Similar intended use: A networked DICOM and non-DICOM information and data management system for image storage, display, manipulation, and quantitative measurements (excluding mammographic use).
• Similar technological characteristics/features: As detailed in the predicate device comparison table, the TouchPACS Suite provides identical or comparable functionalities (e.g., TCP/IP communication, image archiving, processing, editing, patient demographic editing, DICOM print, various compression methods).
• No new safety and efficacy issues: A hazard analysis was conducted, and the device is deemed a "minor level of concern."

The "study" that proves the device meets these "acceptance criteria" is the comparison to predicate devices and the internal verification and validation testing of the software. The document states:

• "The TMS TouchPACS Suite has similar intended use and technical features of the predicate devices listed above."
• "A comparison of the labeling, substantial equivalence table, and verification and validation testing has established that the device meets its intended use and design specifications."
• "Potential hazards are identified through risk analysis and managed through the software development process and verification/validation testing."

The document also highlights compliance with relevant standards like ACR/NEMA DICOM Version 3.0, IEC60950, and IEC/CISPR 22 as part of its safety and design verification.

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