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Zurich Pressure Guidewire System is indicated to measure physiological parameters in the coronary and peripheral blood vessels and in the heart. Zurich Pressure Guidewire System is also indicated to direct a catheter through a blood vessel.

The Zurich Pressure Guidewire System Model 100™ ("Zurich Pressure Guidewire System") consists of a 0.014" (0.36 mm) diameter, 180 cm long Interventional Guidewire with a high fidelity sensor located immediately beyond the 3 cm shapeable radiopaque tip and a uniquely paired Portable Display. The signals from the sensor can be used to measure blood pressures and calculate Fractional Flow Reserve (FFR). The Guidewire is connected to the Portable Display via the Handle. The distal end has hydrophilic coating. The Portable Display also has an AO Cable that may be used to connect to the Zurich Medical Accessory Cable for AO pressure signal.

The provided document is a 510(k) premarket notification for the Zurich Pressure Guidewire System Model 100. Its purpose is to demonstrate substantial equivalence to existing predicate devices, not primarily to prove performance against specific acceptance criteria for a new clinical indication. Therefore, the document does not contain the detailed information requested regarding acceptance criteria for an AI/device performance study, such as specific metrics (e.g., sensitivity, specificity), sample sizes for test sets, expert adjudication methods, MRMC studies, or detailed ground truth establishment.

The document primarily focuses on:

• Device Description and Intended Use: The Zurich Pressure Guidewire System is indicated to measure physiological parameters in coronary and peripheral blood vessels and the heart, and to direct a catheter through a blood vessel.
• Comparison to Predicate Devices: It highlights similarities and minor differences in intended use, indications for use, technological characteristics, and physical properties compared to two predicate devices (PressureWire™ Certus™ guidewire and RadiAnalyzer™ Xpress portable display).
• Non-Clinical Testing: A summary of non-clinical (bench and animal) testing performed to demonstrate that the device meets its physical and performance specifications and is safe and effective. These tests are primarily related to general medical device safety and functionality (e.g., EMC, electrical safety, biocompatibility, sterility, software verification and validation).

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes for test sets, information on expert ground truth, or details of MRMC studies as these are not present in the provided text for this specific medical device submission.

The document does mention:

• Non-Clinical Testing (similar to a standalone performance evaluation in a broader sense):

  • The Zurich Pressure Guidewire System has undergone extensive non-clinical testing to meet its physical and performance specifications. This includes electromagnetic compatibility, electrical safety, biocompatibility, packaging validation, labeling compliance, sterilization, human factors, shelf life, animal studies (under GLP guidelines), and various Guidewire/Portable Display/System software and bench verification tests (e.g., diameter, tensile, kink, pushability, torque, flexibility, coating uniformity, corrosion, lubricity, fatigue, fracture, dimensional, particulate).
  • Study Proving Device Meets Acceptance Criteria: "The testing showed that the device meets specifications before and after aging, indicating that the device is as safe and effective as the predicate devices." (Page 6)
  • This implies that the "acceptance criteria" here refer to the specifications and requirements outlined by various standards (IEC, AAMI, ISO, ASTM) and FDA guidance for the type of device. The "study" proving it meets these is the sum of all the non-clinical tests mentioned.
  • Type of Ground Truth: For non-clinical tests, the "ground truth" is typically derived from physical measurements against established engineering specifications, animal study observations, and compliance with industry standards.

• Training Set Information:

  • There is no mention of a training set in the context of an AI/machine learning model. This submission is for a physical medical device (pressure guidewire system), not an AI algorithm.

In summary, the provided text does not contain the specific information requested under points 1-9 because the device and its submission type (510(k) for substantial equivalence of a physical device) do not typically involve the kind of AI/algorithm performance studies implied by your questions.

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