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Model 2908 Mammo pro is intended for covering analog Medical x-ray films to digital images.

The device is indicated for the digitization of mammography Imaged for review and analysis, but not as the sole basis for screening or diagnosis.

The device is indicated for the digitization of mammography images for storage and display not for primary image diagnosis.

Film Digitizer, Model 2908 Mammo Pro

The provided document is a 510(k) clearance letter from the FDA for a medical image digitizer (Film Digitizer, Model 2908 Mammo Pro). It does not contain details about specific acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Therefore, I cannot provide the requested information as the source document does not contain it. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) are typically found in the 510(k) submission document itself, or in associated test reports, which are not part of this clearance letter.

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Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.

This device has no patient contacting materials and is intended to be used by trained personnel only.

The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.

Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.

The provided document is a 510(k) clearance letter from the FDA for a medical image digitizer (Film Digitizer, Model 2908). This document grants market clearance for a device based on its substantial equivalence to a predicate device. It does not contain any information regarding acceptance criteria, study details, or device performance against specific metrics.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document focuses on regulatory approval rather than technical performance validation.

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The Laser Film Digitizer 2905 is indicated for scanning medical radiographs with a laser beam and generating a digital electrical signal from the transmitted light.

The Laser Film Digitizer 2905 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images as the digital data to a computer. It has the following features:

• (1) Since the 2905 is equipped with a photomultiplier having wide dynamic range as a sensor, it can read high density films, such as a film whose optical density is up to 4.0.
• 2 The 2905 can output 4096 gray levels (12 bits) which are linear to optical density.
• 3. The 2905 can read a film at high speed using laser.
• 4 The interface of the 2905 is SCSI-2, so that it can transfer data at high speed.

The provided text describes a 510(k) premarket notification for a Laser Film Digitizer (Model 2905) and focuses on its substantial equivalence to predicate devices. It does not contain information about an acceptance criteria table, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document primarily acts as an application to market the device, demonstrating its features and compliance with safety standards in comparison to existing, cleared devices.

Therefore, I cannot provide the requested information from the given text.

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