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The Verrata™ Pressure Guide Wire device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The Verrata™ Pressure Guide Wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata guide wire measures pressure when used with the SmartMap, s5 Family and ComboMap systems. The Verrata guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and also in straight or pre-shaped J tips. The Verrata guide wire is packaged pre-connected to the connector with a torque device to facilitate navigation through the vasculature.

The provided text corresponds to a 510(k) summary for the Volcano Verrata™ Pressure Guide Wire. Based on the document, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding reported device performance values for the Verrata™ Pressure Guide Wire. Instead, it lists the types of non-clinical tests conducted and states that their completion led to the conclusion of substantial equivalence.

However, based on the tests conducted to confirm performance, we can infer generalized acceptance criteria. The performance is reported as meeting these inferred criteria, leading to the conclusion of substantial equivalence.

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

The document does not explicitly state the sample sizes for the "test set" for each of the non-clinical tests (Visual Inspection, Dimensional Verification, Wire Connection Durability, Tensile Strength, Connector Resistance). These tests are typically performed on a statistically relevant number of device units.

Regarding data provenance, the testing was non-clinical, meaning it was conducted in a laboratory or benchtop setting, not using human or animal biological data. The data origin is therefore within the scope of Volcano Corporation's internal testing facilities. It is inherently retrospective as these tests precede the 510(k) submission.

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

This information is not applicable to this submission. The tests performed are non-clinical (bench testing), which typically do not involve human experts establishing ground truth in the way clinical studies or image-based AI studies do. The "ground truth" for these tests would be established by engineering specifications, calibration standards, or measurement devices.

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

This information is not applicable to this submission. Adjudication methods are typically used in clinical studies, particularly those involving human interpretation of data (e.g., medical imaging), to resolve discrepancies between readers. Bench testing does not involve such human-in-the-loop decision-making that would require adjudication.

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

An MRMC comparative effectiveness study was not performed. This submission is for a physical medical device (pressure guide wire), not an AI algorithm or a diagnostic imaging device that involves human readers interpreting results. Therefore, there is no mention of human reader improvement with or without AI assistance.

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

This information is not applicable. The Verrata™ Pressure Guide Wire is a physical medical device. It is not an algorithm, and therefore, standalone algorithm performance is not relevant to this submission.

7. The type of ground truth used

For the non-clinical tests mentioned (Visual Inspection, Dimensional Verification, Wire Connection Durability, Tensile Strength, Connector Resistance), the "ground truth" would be established by:

• Engineering specifications and design documents: For visual inspection and dimensional verification.
• Known standards/reference materials and calibrated measurement equipment: For wire connection durability, tensile strength, and connector resistance.
• The predicate device: For substantial equivalence, the performance is compared against the established performance of the legally marketed predicate device (Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire).

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing processes are developed through engineering and materials science, not machine learning training.

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

This information is not applicable for the same reasons as #8.

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