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The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.

The Imagyn Falloposcopy System consists of the following components:
Linear Everting (LE) Fallopian Tube Access Catheter
Falloposcope

I am sorry, but the provided text does not contain sufficient information to describe the acceptance criteria and the study that proves the device meets those criteria in the structured format you requested.

The document is a 510(k) summary for the Imagyn Falloposcopy System and primarily focuses on:

• Identification of the device and manufacturer.
• Identification of predicate devices.
• Description of the device and its intended use.
• Technological comparisons to predicate devices.
• A general statement that "Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use."

However, it does not provide details on:

• Specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
• Any performance metrics achieved by the device.
• Sample sizes for test sets or training sets.
• Data provenance.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether MRMC studies were performed.
• Whether standalone algorithm performance was assessed (the device described is a physical medical device, not an AI algorithm).
• The type of ground truth used (beyond the general statement of "clinical tests").
• How ground truth for the training set was established.

Therefore, I cannot populate the requested table or answer the specific questions about the study design with the given input.

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