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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. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).

The provided text describes the PressureWire™ X guidewire, a medical device used to direct catheters and measure physiological parameters like blood pressure and temperature. The submission is a Special 510(k), indicating a minor design modification to an already cleared device (K161171). As such, a detailed comparative effectiveness study with human readers or extensive clinical trials are not typically required for this type of submission. The focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modification does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a Special 510(k) like this, the "acceptance criteria" are primarily based on demonstrating that the modified device performs comparably to the predicate device and meets established performance standards for its type. The reported device performance centers on various bench tests.

Note: The text states "Tests were conducted to evaluate the following: ... Additionally, simulated-use testing was completed as part of design validation to demonstrate the subject device met user needs and the intended use. The following test was performed: Signal Drift." It implies all these items were successfully met to demonstrate safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of units for each test. The text outlines categories of tests (e.g., Tensile Strength, Torque Strength) and generally states "Performance bench testing was completed as part of design verification" and "simulated-use testing was completed as part of design validation." Typically, for bench testing, a statistically relevant number of samples would be tested to ensure reliability. However, this specific number is not disclosed in the summary.
• Data Provenance: The testing was "Performance bench testing" and "simulated-use testing." This indicates the data was generated in a controlled laboratory environment, not from human or animal subjects. Thus, there's no "country of origin of the data" in the typical sense, nor is it retrospective or prospective clinical data. It's pre-market engineering and product verification/validation data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable or mentioned. The "ground truth" for bench testing is defined by engineering specifications, validated test methods, and industry standards (e.g., for tensile strength, torque strength).
• Qualifications of Experts: Not applicable. The tests are designed to objectively measure physical and electrical properties according to predefined methods and pass/fail criteria.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench tests typically involve objective measurements and comparisons against predetermined specifications rather than subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No. The device is a physical guidewire with measurement capabilities, not an AI-powered diagnostic imaging tool that assists human readers in interpreting medical cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable here.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" device. The PressureWire™ X is a hardware device with an integrated sensor. Its "standalone performance" is demonstrated through the various bench tests ensuring the physical and measurement properties meet specifications.

7. The type of ground truth used

• Type of Ground Truth: For the "test set" (bench and simulated-use testing), the ground truth is based on engineering specifications, established physical properties, and validated measurement techniques. For example, a tensile strength test would have a pre-defined acceptable range of force the wire must withstand, and the measured force is compared against that objective standard.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical hardware product. It does not employ machine learning or AI algorithms that require a "training set" of data in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing, not algorithmic data training.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" for an AI algorithm in this context. The "ground truth" during the device's development (design and iterative testing) would similarly be based on engineering principles, material science, and performance specifications derived from intended use and predicate device characteristics.

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