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The XGEO GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.

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This document is a 510(k) premarket notification for the SAMSUNG ELECTRONICS Co., Ltd. XGEO GR40CW, a stationary x-ray system. The document states that the device is substantially equivalent to the predicate device XGEO GC80 (K123098). However, it does not contain the detailed study information required to fill out all the requested fields about acceptance criteria and study proving device meets the acceptance criteria.

The provided text focuses on the administrative aspects of the 510(k) submission and the FDA's regulatory response, rather than providing technical details of performance studies or acceptance criteria.

Therefore, I cannot provide a complete answer based on the provided text.

Specifically, the following information is not present in the provided document:

• A table of acceptance criteria and the reported device performance: This information is typically found in the performance testing section of a 510(k) submission, which is not included here.
• Sample sized used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method for the test set: Not provided.
• 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: This is a traditional X-ray system, not an AI device, so this type of study would not be applicable or expected.
• If a standalone (i.e., algorithm only without human-in-the loop performance) was done: As above, this is not an AI device.
• The type of ground truth used: Not provided.
• The sample size for the training set: Not provided (and likely not applicable as it's not an AI/ML device).
• How the ground truth for the training set was established: Not provided (and likely not applicable).

The document is primarily a 510(k) summary and the FDA's clearance letter, which includes the device name, manufacturer, contact information, classification, predicate device, and the intended use statement. It confirms the FDA's determination of substantial equivalence but does not delve into the specifics of the performance studies conducted to support that determination.

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