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The indications for use of the Fuji Computed Radiography (FCR) ClearView CS Image Reader with initials frials (1) processing of diagnostic x-ray images of the human body, and associating patient and exam identification with the images.

A Fuil Computed Radiography (FCR) system typically consists of an image reader (IR), patient ID terminal, imaging plates (IPs), IP cassettes, interface board, positioning monitor, laser printer for hard copy output, and optionally an image workstation, optical disk file, and network interface. This notification is for the image reader and associated imaging plates (IPs). IPs are used as twodimensional radiation detectors in place of radiographic film and intensifying screens to capture a portion of the projected x-ray patient image. In the image reader, the captured image data is associated electronically with patient and exam identification data and the latent image is read by laser emission by the phenomenon of photostimulable luminescence. The photostimulated fuminescence is then collected, sampled, and digitized. The image data is then digitally processed according to exam and user-specified parameters and may be displayed on a CRT monitor to confirm patient positioning, printed by a hard copy device (such as laser printer, or dry printer), or output to a workstation, optical disk file, or other destination. The device performs no lossy compression of image data.

FCR ClearView CS consists of an Image Reader and Imaging Plates of various sizes and types (described below). The Image Reader is casselle-based. The IP is placed into a cassette and exposed using standard x-ray equipment. The cassette containing the exposed image plate is then manually inserted into the ClearView CS Image Reader. The image reader automatically removes the IP from the cassette and moves the IP to the reading position where it is scanned by a laser beam. The luminescence from the IP is then converted to an electrical signal by a pholoelectron multiplier

The provided text does not contain a detailed study description with acceptance criteria and a comprehensive report of device performance against these criteria. Instead, it is a 510(k) Summary for the Fuji Computed Radiography (FCR) ClearView CS Image Reader, which focuses on device description, intended use, and substantial equivalence to predicate devices. It does not include information about clinical studies, expert-established ground truth, sample sizes for training or test sets, or comparative effectiveness with human readers.

Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about acceptance criteria, study details, or performance metrics from the given text.

The closest information related to performance is a comparison of technical characteristics between the FCR ClearView CS and predicate devices, as shown in the table on page 1. This table lists various parameters like image recording, patient identification, reading method, laser type, sampling raster, gray scale, physical dimensions, weight, throughput, and processing time. However, these are technical specifications, not acceptance criteria for clinical performance or outcomes, nor is there a report on how the device performed against any such criteria.

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