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The ACCUNET™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The ACCUNET™ Embolic Protection System is an over-the-wire, filtration-type, embolic protection device, filtering distal to the interventional site. The ACCUNET™ System is delivered via a Delivery System, utilizing a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once the Guide Wire is across the lesion, the Filter Basket is expanded in the artery lumen by removing the Delivery Sheath. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery System, retaining any potential embolic collected during the procedure. The system and any captured embolic particles are then removed through the guiding catheter or sheath.

Like the ACCUNET™ Embolic Protection System, the RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The RX ACCUNET™ System is delivered in a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by advancing the Filter Basket from the Delivery Sheath from the Guide Wire using the torque device. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit.

The provided text describes the ACCUNET™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System. It outlines the indications for use and mentions several studies conducted to demonstrate its safety and effectiveness. However, it does not explicitly provide a table of acceptance criteria with reported device performance or detail the specific acceptance criteria for each test. Instead, it generally states that the device was considered "substantially equivalent" to a predicate device and that studies demonstrated acceptable functional performance.

Here's an attempt to structure the available information regarding acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a direct table of acceptance criteria with corresponding performance metrics. It rather indicates a general claim of "substantially equivalent."

2. Sample Sizes and Data Provenance:

• Clinical Trials (ARCHeR 1, ARCHeR 2, ARCHeR 3):
  • Sample Size (Total): 657 patients.
  • Data Provenance: United States (45 clinical sites) and five sites outside of the United States.
  • Retrospective/Prospective: Prospective, non-randomized, multi-center, single-arm clinical trials.
• Animal Studies:
  • Sample Size: Not explicitly stated, but performed in non-atherosclerotic swine.
• In Vitro Testing:
  • Sample Size: Not explicitly stated, but included biocompatibility, sterilization, packaging and shelf-life, and product performance testing.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

The document does not mention the use of experts to establish ground truth for a test set in the context of device performance, as it is a medical device for embolic protection rather than an AI/diagnostic software. The clinical trials aimed to demonstrate the device's safety and effectiveness in patients, with outcomes being the primary measure.

4. Adjudication Method for the Test Set:

Not applicable in the context of this medical device approval, as there is no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Clinical outcomes from the ARCHeR trials were used.

5. MRMC Comparative Effectiveness Study:

Not applicable. This is a medical device, not an AI or imaging diagnostic software that would involve human readers.

6. Standalone Performance Study:

The clinical trials (ARCHeR) evaluated the performance of the ACCUNET™ and RX ACCUNET™ Embolic Protection Systems in conjunction with the ACCULINK™ and RX ACCULINK™ Carotid Stent Systems. Therefore, it's not strictly a "standalone" or "algorithm-only" performance in isolation, but rather its performance as part of a therapeutic system. The animal and in-vitro studies also assessed the device's performance directly.

7. Type of Ground Truth Used:

• Clinical Trials (ARCHeR): The "ground truth" was based on clinical outcomes in patients (e.g., primary endpoint rates which would likely include stroke, MI, death), as defined by the study protocols.
• Animal Studies: In vivo functional performance and biological responses.
• In Vitro Testing: Adherence to established performance standards and guidance documents.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI algorithm that requires a training set. The term "training set" is typically used in machine learning. The clinical trials served as the pivotal studies for demonstrating device effectiveness and safety.

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

Not applicable, as there is no "training set" in this context.

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