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The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

The SimGrid is a technology that enhances the visibility of major clinical equipment by compensating for the decrease in contrast that is caused by scatter radiation when the portable grid is not used for portable images.

Bone Suppression is a technology that helps to create images with good lung field visibility by removing part of the ribs and clavicle with S/W algorithms. It is used as diagnosis assistance for areas that the image reader is interested in, such as soft tissues and lesions in the lung field.

The GC85A digital X-ray imaging system is used to capture images by transmitting Xray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

The SimGrid is a post-image processing software option which is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical antiscatter grid.

The Bone Suppression Image (BSI) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The BSI software option suppresses bone anatomy to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.

The SimGrid and BSI are available as options to be exclusively installed in S-station, which is a Samsung Digital X-ray operation S/W, since this post-image processing software does not depend on how the image is acquired, or with what acquisition device.

The provided text describes the Samsung GC85A Digital X-ray Imaging System, which includes two post-image processing software options: SimGrid and Bone Suppression Image (BSI). However, the document does not contain a detailed study with specific acceptance criteria and reported device performance metrics in tabular form for these software features.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and generally mentions evaluations without providing quantifiable acceptance criteria or detailed study results.

Here's a breakdown of the information that can be extracted or inferred regarding the evaluation of SimGrid and BSI, along with the information that is not available in the provided text:

SimGrid Evaluation:

• Acceptance Criteria: Not explicitly stated as a quantifiable metric. The stated goal is to "demonstrate that SimGrid processing gives the better local contrast than images acquired without a grid."
• Reported Device Performance: SimGrid processing was found to "give the better local contrast than images acquired without a grid." The "usefulness was validated by a radiographer using clinical images."
• Sample Size (Test Set): "various phantoms at various exposure conditions" and "clinical images." Specific numbers are not provided.
• Data Provenance (Test Set): Not specified (e.g., country of origin, retrospective/prospective).
• Number of Experts & Qualifications (Test Set Ground Truth): "radiographer" validated usefulness. No specific number or detailed qualifications (e.g., years of experience) mentioned.
• Adjudication Method: Not specified.
• MRMC Comparative Effectiveness Study: Not mentioned or implied.
• Standalone Performance: SimGrid software was evaluated with phantoms and clinical images, implying a standalone assessment of its image processing output.
• Type of Ground Truth: For phantoms, it would be based on known phantom properties and quantitative analysis of contrast. For clinical images, it's based on a "radiographer's" qualitative assessment of "usefulness."
• Sample Size (Training Set): Not provided.
• Ground Truth Establishment (Training Set): Not provided.

Bone Suppression Image (BSI) Evaluation:

• Acceptance Criteria: Not explicitly stated as a quantifiable metric. The goal is to provide "good lung field visibility by removing part of the ribs and clavicle" and be "useful as diagnosis assistance."
• Reported Device Performance: "Overall quality of the bone suppressed images was found to be useful as diagnosis assistance for areas that the reader is interested in, such as soft tissues and lesions in the lung field."
• Sample Size (Test Set): "various kinds of clinical images, such as with various sizes of patients at various exposure conditions." Specific numbers are not provided.
• Data Provenance (Test Set): Not specified (e.g., country of origin, retrospective/prospective).
• Number of Experts & Qualifications (Test Set Ground Truth): "a professional radiologist" evaluated the images. No specific number or detailed qualifications (e.g., years of experience) mentioned.
• Adjudication Method: Not specified.
• MRMC Comparative Effectiveness Study: Not mentioned or implied.
• Standalone Performance: BSI software was evaluated with clinical images, implying a standalone assessment of its image processing output.
• Type of Ground Truth: Based on a "professional radiologist's" qualitative assessment of "usefulness as diagnosis assistance."
• Sample Size (Training Set): Not provided.
• Ground Truth Establishment (Training Set): Not provided.

Summary of what's missing for a comprehensive answer to your request:

• Specific, quantifiable acceptance criteria for both SimGrid and BSI.
• Actual quantitative performance metrics for SimGrid (e.g., contrast improvement ratios, SNR, human reader performance).
• Detailed quantitative or qualitative performance metrics for BSI (e.g., lesion conspicuity, false positive/negative rates, agreement with original images).
• Specific sample sizes for both test and training sets.
• Detailed information about the data provenance (retrospective/prospective, specific demographics, geographic origin).
• Precise qualifications and number of experts for establishing ground truth.
• Details on the adjudication method used for the test set.
• Any information regarding MRMC studies and effect sizes.
• Information on the ground truth establishment for training sets, if applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general safety/performance testing, rather than providing detailed clinical study results with specific acceptance criteria for the added software features.

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