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PressureWire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The modified PressureWire™ is essentially a modification of the previously cleared PressureWire™ (K113584). The subject device, The subject and predicate device, PressureWire is a 0.014" guidewire with an integrated sensor element at the tip to enable measurements of physiological parameters. The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris. PressureWire is available in different lengths.

The provided document is a 510(k) summary for a medical device (PressureWire™) and does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document states:

• "A summary of PressureWire™ Design Control Activities with regards to risk analysis and verification and validation activities is provided in this 510k submission."
• "The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications."
• "Based on passing verification specification criteria for mechanical and signal testing along with chemical characterization and biocompatibility, PressureWire™ performs substantially equivalent to predicate devices."

However, the actual acceptance criteria, the specific studies performed, sample sizes, ground truth establishment methods, or expert involvement are not detailed in this public 510(k) summary. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K113584) based on minor modifications.

Therefore, I cannot complete the table or answer the specific questions about the study within the provided text.

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