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IntelePACS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.

IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.

This document is a 510(k) Summary of Safety and Effectiveness for the IntelePACS™ device, submitted by Intelerad Medical Systems Inc. It outlines the device details and establishes substantial equivalence to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria with performance metrics, sample sizes, or ground truth details.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence, not on a detailed performance study with acceptance criteria.

Information not available in the provided text:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics or acceptance criteria are reported. The document states that "adequate information and data" were provided to determine substantial equivalence but doesn't detail what that data contained regarding performance.
• Sample Size for Test Set and Data Provenance: Not mentioned.
• Number of Experts and Qualifications for Ground Truth: Not mentioned.
• Adjudication Method: Not mentioned.
• Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not mentioned.
• Standalone (algorithm only) Performance Study: Not mentioned.
• Type of Ground Truth Used: Not mentioned.
• Sample Size for Training Set: Not mentioned.
• How Ground Truth for Training Set was Established: Not mentioned.

Summary of what the document does include:

• Device Name: IntelePACS™
• Common Name: Picture Archiving Communications System
• Classification: 21 CFR 892.2050, System, Image Processing (Class II)
• Predicate Device: PACSPLUS (K023460) from MEDICAL STANDARD CO., LTD.
• Indications for Use: Receives digital images and data from various sources; communicates, processes, manipulates, enhances, stores, and displays images and data within the system or across networks.
• Technological Characteristics: Medical device image software for PACS, used with computer hardware, does not contact the patient, does not control life-sustaining devices, and images are interpreted by a physician with human intervention.
• Conclusion: Device is substantially equivalent to the predicate. Compliance with voluntary standards, hazard analysis ("minor" concern level).

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