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The PressureWire™ X guidewire 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. Physiological parameters include blood pressure. The PressureWire™ X Guidewire can also measure blood temperature.

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

This document is a 510(k) premarket notification for the PressureWire™ X device, which is a catheter tip pressure transducer and guidewire. The content primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, device performance metrics, or specific study designs as would be found in a clinical trial report.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided from this document. The document describes design verification and validation testing rather than acceptance criteria for a diagnostic algorithm studied in a clinical setting.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria for a diagnostic performance study (e.g., sensitivity, specificity, accuracy). Instead, it refers to compliance with various standards and internal design control procedures for physical, mechanical, and coating integrity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is primarily bench testing and compliance with standards, not a clinical study on a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided because the document describes verification and validation against pre-defined engineering and material standards, not the establishment of ground truth for a diagnostic performance test set by clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device (PressureWire™ X) is a physical guidewire with sensing capabilities, not an AI or imaging diagnostic algorithm that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation for a diagnostic algorithm is not applicable here as the device is a medical instrument (guidewire) for measuring physiological parameters, not an algorithm. Its performance relates to its ability to accurately measure pressure and temperature, as well as its physical and mechanical properties. The document states a "testing summary" was done, concluding it is "safe and effective."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the physical and mechanical tests, the "ground truth" would be the established engineering specifications and manufacturing standards (e.g., specific friction force values, wire diameter tolerances). For biocompatibility and sterilization, the ground truth is compliance with the cited ISO and USP standards.

8. The sample size for the training set

This information is not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

This information is not provided as it's not applicable to this type of device.

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