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The TULSA-PRO ® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the "Tulsa Pro System (Pad-105)" does not contain any information regarding acceptance criteria, device performance studies, or the methodologies used to prove the device meets acceptance criteria.

The letter is a regulatory document confirming substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed. It discusses:

• The FDA's determination of substantial equivalence.
• Regulatory requirements and general controls (annual registration, listing, GMP, labeling, etc.).
• Links to guidance documents for changes requiring new premarket notifications.
• Information about the Quality System (QS) regulation.
• Advice on adverse event reporting and other regulatory information.
• The product's indications for use.

To answer your detailed questions about acceptance criteria and study design, you would typically need to refer to:

• The actual 510(k) submission itself: This document would contain the detailed study protocols, results, and acceptance criteria presented to the FDA.
• Clinical trial publications: If the device underwent clinical trials, the scientific papers would provide this information.
• The device's Instruction for Use (IFU) or technical manual: Some performance claims and supporting data might be summarized here.

Without that specific documentation, I cannot create the table or provide the detailed answers you requested.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device