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To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or other any interventional procedures. Blood pressurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.

The OptoWire Deux is a hybrid Nitinol/Stainless Steel pressure sensing guidewire that is a steerable guidewire with an optical pressure sensor mounted proximal to the 3.5 cm long radio opaque tip. The OptoWire Deux is for use in combination with Opsens' OptoMonitor system for blood pressure measurement. The OptoWire Deux has a diameter of 0.014" (0.36 mm) and an effective length of 175 cm. The OptoWire Deux is supplied preconnected to the OptoWire cable along with a torque device. The OptoWire cable is unique to each OptoWire and it must be used conjunctionally with the OptoWire supplied in the same tray. OptoWire Deux is supplied sterile, non-pyrogenic and is intended for single use only. The changes described in this special 510k device modification only affect the OptoWire. There are no change to the OptoMonitor device included in the cleared systems K142598.

The Opsens OptoWire Deux pressure guidewire is designed to measure blood pressure in coronary and peripheral vessels during diagnostic angiography and interventional procedures, providing hemodynamic information such as fractional flow reserve (FFR). The device is a hybrid Nitinol/Stainless Steel steerable guidewire with an optical pressure sensor.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (OptoWire One, K142598) through verification and validation tests rather than explicitly stating acceptance criteria and numerical performance for all aspects. However, some key performance specifications are listed and implicitly serve as acceptance criteria for functionality.

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

The document does not explicitly state a specific "test set" for a clinical study. Instead, it describes a series of bench tests and biocompatibility tests to demonstrate that the OptoWire Deux complies with the performance data from its predicate device.

• Bench Tests: "Each of these tests were performed on finished, sterilized OptoWire Deux samples." The exact number of samples for each specific bench test (e.g., Turn-to-failure, Fatigue, Torque Strength, etc.) is not specified in the provided text.
• Biocompatibility Tests: "Each of these tests were performed on finished, sterilized OptoWire Deux samples." The exact number of samples is not specified.
• Data Provenance: The device performance data is derived from bench testing and biocompatibility testing conducted by the manufacturer (Opsens, Inc. in Quebec, Canada) to support the substantial equivalence claim. This is a pre-clinical, prospective testing scenario rather than a clinical data provenance.

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

This information is not applicable as the document describes pre-clinical bench testing and biocompatibility assessments, not a study involving human interpretation or clinical ground truth. The "ground truth" for the engineering and material performance aspects would be defined by established standards, test methodologies, and specification limits, not expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Testing results are compared against predefined technical specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

This information is not applicable. The OptoWire Deux is a physical medical device (guidewire) used for pressure measurement, not an AI or imaging-based diagnostic tool that would typically involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable as the device is a physical guidewire, not a standalone algorithm.

7. The Type of Ground Truth Used:

For the performance and biocompatibility aspects, the "ground truth" is established by:

• Engineering Specifications: Defined parameters for guidewire dimensions, shaft material properties, coatings, and pressure sensing capabilities (e.g., pressure range, accuracy, thermal zero shift, zero drift).
• Standardized Test Methods: Adherence to recognized national and international standards for medical device testing (e.g., ISO 10993-1:2009 for biocompatibility, and various bench test methods for mechanical performance).
• Predicate Device Performance: The OptoWire One (K142598) serves as the benchmark, with the OptoWire Deux demonstrating comparable performance.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of this device's pre-market submission, as it is not an AI/machine learning device. The design, materials, and manufacturing processes are developed based on engineering principles and previous device experience.

9. How the Ground Truth for the Training Set Was Established:

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

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