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The PressureWireTM System is indicated for the measurement of blood pressure in the coronary vasculature and to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).

The RADI Medical Systems PressureWire™ System consists of a guidewire with a nearend mounted pressure sensor and an interface to facilitate connection to an ordinary pressure-monitoring system.

The provided text is a 510(k) summary for the Radi Medical Systems PressureWire™ System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a robust clinical study as would be expected for a novel AI device. Therefore, much of the requested information (e.g., sample sizes for testing and training, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or not available in this type of submission.

The document indicates that "Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices." However, it does not provide specific acceptance criteria or detailed results of a study designed to meet those criteria.

Key points from the document regarding "acceptance criteria" and "study":

• Substantial Equivalence: The primary "acceptance criterion" for this 510(k) submission is that the device is "substantially equivalent" to legally marketed predicate devices.
• Predicate Devices: The predicate devices are listed as "ACS Guidewires" and "Millar Pressure Measurement System."
• Performance Data: The document generally states that "Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices."
• Technical Characteristics: It mentions that "The mechanical properties of the PressureWire™ Sensor are similar to ACS Guidewires" and "The technical properties of PressureWire™ System are similar to the Millar Pressure Measurement System." This is the extent of the "performance data" provided. No specific numerical data or detailed study results are given.

Given the nature of this 510(k) summary, which predates modern AI/ML device evaluations, the requested information cannot be fully provided.

Here's a breakdown of the available and missing information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numerical acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) or detailed study results (means, standard deviations, confidence intervals, p-values) are provided in this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. Substantial equivalence claims often rely on bench testing and comparisons to predicate device specifications, rather than a clinical "test set" in the context of an AI device.
• Data Provenance: Not specified, but likely laboratory/bench data and existing literature on predicate devices. No mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This type of information is not relevant for a 510(k) submission focused on substantial equivalence of a physical medical device, especially not one involving AI. "Ground truth" in this context would likely refer to established engineering standards or performance characteristics of predicate devices, not expert human interpretations of diagnostic data.

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

• Not Applicable. No human adjudication method would be used for this type of device and submission.

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:

• Not Applicable. This device is a physical guidewire with a pressure sensor; it is not an AI-powered diagnostic or assistive tool for human readers.

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

• Not Applicable. This is not an AI algorithm.

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

• Implicitly: The "ground truth" for demonstrating substantial equivalence would be the established performance specifications and safety profiles of the predicate devices and generally accepted engineering and biocompatibility standards for similar devices. No "expert consensus," "pathology," or "outcomes data" in the AI sense would be used to establish ground truth for this device's performance given the available information.

8. The sample size for the training set:

• Not Applicable. This device does not involve a training set as it is not an AI/ML product.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

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