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The KODAK Medical Imager 300 Imager is intended use as a hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the Medical Imager 300 and transformed thermally to develop Eastman Kodak imaging media. The system of printer and physical image is intended for use with a variety of modalities, including, but not limited to CR, DR, CT, MRI, Ultrasound, Nuclear Medicine, etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients. The system of printer and physical image is not a high resolution device and is not intended for use with FFDM systems.

The imagers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK imaging media is removed from a cartridge and transported to the imaging station. Image data addresses the individual pixel elements in the thermal print head. The heat of the thermal head reacts the thermally sensitive film to produce the image and the film exits the printer. Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.

The provided text focuses on the 510(k) summary for the KODAK Medical Imager 300 Thermal Printer, which is a hardcopy device for medical images. It primarily discusses the device's intended use, technological characteristics, and its substantial equivalence to a predicate device based on safety standards.

Crucially, the document does NOT contain information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

The "Performance Data" section merely states: "Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 2601-1, IEC 60601-1, ISO 12207 and ISO 14971." This refers to compliance with general industry and safety standards for medical devices, not specific diagnostic performance metrics or a study demonstrating clinical accuracy.

Therefore, I cannot fulfill your request for the detailed table and study information as the provided text lacks this content. The device described is a thermal printer, which outputs images, and its performance is assessed in terms of image quality consistency and safety compliance, rather than diagnostic accuracy metrics typically associated with AI/CAD devices.

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