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The Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

The Digital Radiographic Imaging System is designed to perform radiographic examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage. The Digital Radiographic Imaging System consists of a wallstand, tubestand, x-ray tube, collimator, system controller, generator and digital detector.

The provided text describes a 510(k) summary for a Digital Radiographic Imaging System by GE Medical Systems. The study aims to demonstrate substantial equivalence to a predicate device, specifically the Advantx Radiographic System combined with an SG-60 vertical wallstand. The primary acceptance criterion revolves around achieving equivalent or better imaging performance compared to film/screen images for diagnostic purposes.

Here is a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The primary focus of the provided text is on image quality for diagnostic equivalence.)

2. Sample size used for the test set and the data provenance:

• Sample Size: 30 paired digital and film/screen images.
• Data Provenance: The text does not explicitly state the country of origin. It mentions studies were conducted at "three different research hospitals," suggesting prospective data collection for the purpose of the study. The phrasing "representative anatomical areas" implies a selection of cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Two radiologists at each of three hospitals, totaling six radiologists.
• Qualifications of Experts: The text identifies them simply as "radiologists." No further details on their experience level (e.g., years of experience, subspecialty) are provided.

4. Adjudication method for the test set:

• The text states that radiologists "evaluated" the images and "found that the digital images had equivalent or better image quality." It does not specify a formal adjudication method like 2+1 or 3+1. It implies a consensus or individual assessment resulting in the stated conclusion.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• A MRMC comparative effectiveness study was not done as described for AI assistance. The study described is a comparison of digital images to film/screen images by human readers, not a comparison of human readers with vs. without AI assistance. The device is the digital imaging system, not an AI assisting human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No standalone (algorithm-only) performance study was described. The study explicitly involved human radiologists evaluating the images.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth was based on expert assessment/consensus of the image quality for diagnostic purposes, comparing the digital images directly to the corresponding film/screen images for the same anatomical areas.

8. The sample size for the training set:

• The text does not provide information about a specific training set or its sample size. The description focuses on the evaluation data. The device itself is an imaging system, not an AI with a distinct training phase in the context usually meant by "training set" for AI/machine learning.

9. How the ground truth for the training set was established:

• As no training set is described in the provided text in the context of an AI/machine learning model, this information is not available.

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