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

The PressureWire™ Sensor is a 0.014" diameter, 183 or 300 cm long guidewire with a pressure sensor mounted three cm from the distal end and a detachable cable for connection to a programmable diagnostic computer manufactured by the submitter.

The provided document is a 510(k) summary for the PressureWire™ Sensor, a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document focuses on regulatory compliance, specifically demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used.
• The sample size for the training set or how its ground truth was established.

This 510(k) summary primarily addresses the regulatory approval process based on similarity to an already approved device (predicate device), rather than presenting a detailed performance study with acceptance criteria.

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