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The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images.

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The provided text is a 510(k) premarket notification approval letter for the DGSCOPE, Release 1.0 device. This document primarily focuses on the regulatory approval and indications for use, rather than detailed performance studies or statistical metrics. As such, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Not available in the provided text. This document is an approval letter, not a performance report.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. The document does not describe any specific test sets or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available.

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

Not available. The DGSCOPE is described as a device for "review of diagnostic medical images" and "displays the processed images." There is no mention of AI assistance or a comparative effectiveness study involving human readers.

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

Not available. The DGSCOPE is described as a display system, not a standalone diagnostic algorithm.

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

Not available.

8. The sample size for the training set

Not available.

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

Not available.

Summary of available information from the document:

• Device Name: DGSCOPE, Release 1.0
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system
• Regulatory Class: II
• Product Code: LLZ
• Indications for Use: The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images.
• FDA Determination: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

To obtain the requested information, one would need to refer to the actual 510(k) submission document or supporting technical files, which are not included in the provided regulatory approval letter.

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