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The PressureWire Sensor is intended for use in coronary and peripheral blood vessels to measure blood pressure during percutaneous procedures and to facilitate the placement of interventional devices.

The PressureWire™ Sensor consists of a pressure sensor mounted steerable guidewire to perform real-time invasive pressure measurement in the vasculature and a detachable cable for connection to RADI Medical Systems PressureWire™ Interface only. The guidewire has an outer diameter of .014" and is 175 cm in length. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

PressureWire™ Sensor is connected to the PressureWire™ Interface via the Interface Cable which has an identification memory chip containing the individual calibration parameters for the sensor.

The readings from the PressureWire™ Sensor and the one measured through a guiding catheter can be used as input for calculation of various indices which require one or two input values e.g. gradient or Fractional Flow Reserve (FFR) etc.

The information provided focuses on the substantial equivalence of the "PressureWire™ Sensor" to a predicate device and does not contain detailed acceptance criteria, a specific study with performance metrics against those criteria, or the other requested study design details.

Here's a breakdown based on the provided text, highlighting the absence of the requested information:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The study was a "bench test," which typically implies laboratory testing rather than human data.

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)

• Not applicable. The study was a bench test evaluating physical impact on a pressure signal, not an assessment requiring expert ground truth on medical images or diagnoses.

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

• Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for a bench test of physical properties.

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

• No MRMC study was done. This device is a medical guidewire with a pressure sensor, not an AI-powered diagnostic imaging tool.

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

• Yes, a standalone bench test was done. The device's performance (impact on pressure signal) was evaluated independently.

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

• For the bench test, the "ground truth" would be the direct measurement of pressure signals, comparing signals with and without the device's presence to determine the impact. This is not an expert consensus, pathology, or outcomes data, but a direct physical measurement.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. As above, this device is not an AI algorithm requiring a training set.

Summary of Device Performance Justification:

The 510(k) submission for the PressureWire™ Sensor relies heavily on the substantial equivalence to its predicate device (PressureWire™ Sensor (K972793)). The document explicitly states:

• "Due to the extreme similarity in design and materials between subject and predicate devices further product performance testing has not been considered necessary."
• "The technical characteristics of PressureWire™ Sensor is almost identical with the predicate device."
• "The device is almost identical with predicate device and found to be suitable for its intended use."

The only performance data mentioned is a bench test to demonstrate that the presence of the new PressureWire™ Sensor within a guiding catheter does not "clinically significantly impact the pressure signal recorded by the catheter." This test was likely performed to address any potential concerns with the specific embodiment of the new device relative to the predicate, even given the overall similarity. However, no specific quantitative acceptance criteria for this impact are provided, nor are detailed results beyond the qualitative statement of "no clinically significant impact."

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