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The device is used in generating digital signals from medical radiographs. The digital signals are intended for use in PACS and tele-radiology.

The device is a transparency, charge coupled device (CCD) scanner which can be used to digitize radiographs or X-ray film. The digitizer reads gray digital information from the image and sends the raw data file to a host computer, for use with a Picture Archiving and Communication (PAC) System or teleradiology software package currently in the market place as separately approved third party software packages or complete PAC system. The user interface for the film digitizer resides in the host application software program. The 960 creates a digital image file from transparent originals. The digital image file is expressed in either 8 or 12 bit grav level file format. The digitizer is connected to a host computer (either PC, Mac or UNIX) via SCSI II. There is no "activate" button the 960. To start an image capture operation, the user must activate the digitizer user interface on the host computer. Overall, The 960 uses a film fed drive which transports the film over the camera as it digitizes the image. Each scan line is captured by the charge coupled device (CCD). The scan line of data is normalized and calibrated to align the response from individual CCD receptors. The image data signal is converted from analog to digital format on the OCP board. The digital signal is then sent to the host via the SCSI II connection with the host computer.

The provided text describes a 510(k) summary for the Howtek 960 Film Digitizer. It outlines the device's characteristics and states that performance testing was conducted. However, the document does not contain specific details about acceptance criteria or the study that proves the device meets those criteria.

Instead, it makes a general statement: "The performance testing results for the 960 Film Digitizer demonstrated that the device meets its intended specifications and therefore, meets the requirements necessary for its intended use as a component of a PAC system or teleradiology software package." It also highlights that the 960 is superior in some performance characteristics (scan rates, density range, gray scale resolution, spatial resolving power) compared to its predicate device, the Howtek Scanmaster DX.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
• Sample size used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method: This information is not present.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The device is a film digitizer, not an AI-assisted diagnostic tool for human readers.
• Standalone performance: While the device is "standalone" in the sense that it digitizes films, the document does not present quantitative standalone performance metrics. It's a component, not an interpretative AI.
• Type of ground truth used: This information is not present.
• Sample size for the training set: This information is not present.
• How the ground truth for the training set was established: This information is not present.

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