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Pronex is used to position a patient for prone breast radiation therapy.

The device comprise two rigid mechanical structures, each incorporating:

• A tabletop for supporting a patient's torso in the prone position such that a treated breast is able to hang down through a tabletop opening. The tabletops for each structure are identical.
• A selection of two application-oriented supporting structures. Each supporting structure is composed of a base for interfacing the device to a couch, and spacers that connect the tabletop to the base such that a space is provided for a treated breast. The applications are imaging and radiation treatment.

The imaging-oriented supporting structure is CT radiation transparent and is compatible with a 70cm bore and with a CT couch. The treatment-oriented supporting structure is treatment-radiation transparent and is compatible with the treatment couch. The supporting structures do not affect the patient's torso positioning on the tabletop, so as to allow imaging and treatment in the same position.

The respective couches provide positioning motion. The intended use, functionality, technological characteristics and materials of the device are similar to those of the predicate devices.

The provided text describes a medical device called "Pronex" and its 510(k) summary for FDA clearance. However, it does not contain the detailed information necessary to complete the requested table and study analysis.

Specifically, the document focuses on:

• The device's name, applicant, contact information, classification, and predicate devices.
• A general description of the device's components and intended use (positioning a patient for prone breast radiation therapy).
• The FDA's determination of substantial equivalence to predicate devices.
• The formal "Indications for Use Statement."

The document does not include any information regarding:

• Acceptance criteria for performance (e.g., specific measurements, thresholds).
• Reported device performance data.
• Details of a study conducted to prove the device meets acceptance criteria.
• Sample size for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study (AI vs. human readers).
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes, expert consensus).
• How ground truth for training data was established.

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided input. The document establishes the device's regulatory clearance based on substantial equivalence to existing devices, inferring that safety and effectiveness are established by this comparison, rather than through a new performance study with explicit acceptance criteria.

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