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The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The iSm Digital X-78V Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The ism Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i *** Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluorosopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or anglography imaging procedures are performed.

The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i'm Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560, Samsung SDX-4336CP), computer, monitor, and the digital imaging system.

I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table or answer most of the questions about the study.

The document discusses validation tests and states that "all release criteria have been met," but it does not provide the specific acceptance criteria or the reported device performance metrics. It also mentions "Clinical Data submitted is consistent with FDA guidance document...," but it does not describe the actual clinical study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for this specific document.

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