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The RX Accunet® LP Embolic Protection System is indicated for use as a quidewire 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 3.25mm to 7.0mm.

The RX ACCUNET® LP Embolic Protection System is a low profile filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET® LP Delivery System, the RX ACCUNET® Recovery Catheter - Shapeable Tip Design and the RX ACCUNET® 2 Recovery Catheter - Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET® LP Guide Wire with Filter Basket is delivered via 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 peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.

The provided text describes a 510(k) submission for the Abbott Vascular RX Accunet® LP Embolic Protection System. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a de novo clinical study with specific acceptance criteria and performance statistics for a new device.

Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth specifics, MRMC studies, or standalone performance) is not provided in a format typically found in clinical trial reports for novel devices.

However, based on the provided text, I can extract and infer some information which broadly aligns with your request for device acceptance in the context of a 510(k) submission.

Summary of Acceptance Criteria and Device Performance (in the context of 510(k) Substantial Equivalence):

The "acceptance criteria" in a 510(k) for a device like this are primarily demonstrated through substantial equivalence to an existing predicate device. The "performance" is shown by proving that the new device is as safe and effective as the predicate.

Here's a breakdown of the other requested information based on the provided text, noting where information is explicitly not available:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated. The submission refers to "bench, in vivo, sterilization qualification and packaging validation studies." For in vivo studies, this would typically involve animal models or human cadaveric studies for device functionality rather than a clinical human test set for a 510(k) substantial equivalence submission for this type of device unless performance was significantly different from a predicate. No clinical trial data on a human test set is presented.
   • Data Provenance: Not specified (country or retrospective/prospective for in vivo).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not Applicable/Not Provided: For a 510(k) submission showing substantial equivalence for device an embolic protection system based on engineering and in vivo performance, expert consensus (like radiologists assessing images) for "ground truth" in the way you describe is typically not part of the required data. The ground truth for this device's performance would be objective measurements from bench testing (e.g., filtration efficacy, tensile strength) and observations from in vivo studies (e.g., deployment, retrieval, arterial wall interaction). The documentation does not detail who conducted these tests or their qualifications beyond implying standard regulatory affairs and engineering teams.

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

   • Not Applicable/Not Provided: This type of adjudication method is used in clinical studies, particularly in imaging or diagnostic device studies where human expert interpretation is a key component. This 510(k) is for a medical device (embolic protection system) where the primary evidence relies on engineering data and in vivo biological performance, not human reader interpretation of diagnostic output.

4. 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 an embolic protection system, not an AI-powered diagnostic or assistive tool. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic tasks.

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

   • Not Applicable: This is a physical medical device, not an algorithm, so "standalone performance" in this context is irrelevant. The "performance" is the device's mechanical and biological function.

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

   • Objective Measurements and In Vivo Observations:
     • Bench Testing: Mechanical properties, filtration efficiency, dimensions, material integrity. Ground truth is derived from engineering measurements and standards.
     • In Vivo Testing: Device maneuverability, deployment, navigation through vasculature, embolic capture, retrieval, arterial wall compatibility. Ground truth here consists of direct observation and measurement in biological models.
     • Biocompatibility: Based on established ISO standards.
     • Sterilization & Packaging: Validation against established industry and regulatory standards.

7. The sample size for the training set:

   • Not Applicable: There is no "training set" in the context of an AI/ML algorithm for this physical medical device. The "training" in device development refers to iterative design, bench testing, and in vivo animal model testing that leads to the final device design.

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

   • Not Applicable: As above, there is no AI "training set" in the traditional sense. The "ground truth" for the device's development would be established through a rigorous design control process, including:
     • Design Inputs: Requirements derived from intended use, predicate device analysis, clinician feedback, and regulatory standards.
     • Design Verification: Bench testing and in vivo studies to ensure the design outputs meet the design inputs.
     • Design Validation: Ensuring the device meets user needs and intended use, often involving simulated use or limited in vivo studies.

In conclusion, the K081549 submission for the RX Accunet® LP Embolic Protection System demonstrates that the device meets "acceptance criteria" by proving substantial equivalence to existing legally marketed predicate devices through comparative analysis of technological characteristics and performance data from bench and in vivo studies, along with sterilization and packaging validation. It does not involve AI or diagnostic imaging interpretations, and thus, many of the requested details related to clinical studies, human readers, or AI training are not applicable.

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