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The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources ( including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally ( on hard drive, written to CD-R media and / or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing and analysis capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras.

The InfiMed Cardiovascular Workstation CWS 5000 provides digital acquisition and review of DICOM images. The CWS 5000 will acquire ACC/NEMA DICOM images or real-time, high resolution 1024 line analog secondary image capture. The CWS 5000 output is ACC/NEMA DICOM. Patient images may be written to CD-R media according to the ACC/NEMA DICOM standards for permanent archive and/or patient interchange. In addition, the CWS 5000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 5000 is compatible with standard network technology and is conformant to DICOM standards.

The InfiMed Cardiovascular Workstation CWS 3000 provides DICOM image review including multi-modality imaging to support diagnosis and therapy of cardiovascular patients. Patient studies may be reviewed in real-time or slow motion using a knob on a dedicated cardiology remote control (optional). MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras. The CWS 3000 is compatible with standard network technology and is conformant to DICOM standards. In addition, the CWS 3000 is available with a high speed direct digital connection to the InfiMed Gold One for filmless operation including DICOM review, CD-R generation and networking.

The provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the InfiMed Cardiovascular Workstation CWS 3000/5000, focusing on demonstrating substantial equivalence to predicate devices.

Instead, the document provides:

• Device Description: Details the functionalities of the CWS 5000 and CWS 3000, including digital acquisition, review of DICOM images, multi-modality imaging support, storage options, and network compatibility.
• Intended Use: Describes the clinical purpose of the device, primarily for digital acquisition and review of cardiac images from various sources, facilitating multi-modality comparison and analysis.
• Predicate Device Comparison: A table comparing the CWS with two Kodak Digital Science Cardiac Viewers (K974086 and K960043) across various technical specifications like archiving format, viewing speed, display resolution, compression, review features, and input/output capabilities.
• Conclusion drawn from comparison: States that the CWS performs similar functions to predicate devices with some new features that do not raise new questions of efficacy or substantial risk.
• FDA Communication: A letter from the FDA indicating review of the 510(k) and a determination of substantial equivalence.
• Indications for Use: A formal statement of the device's intended use submitted to the FDA.

The document explicitly states: "Performance Data: Not required for the determination of substantial equivalence of this device." This indicates that a formal performance study with acceptance criteria was not part of this 510(k) submission process.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as it is not present in the given text.

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