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The RX ACCUNET Embolic Protection System is indicated for use as a guide wire 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 site of filter basket placement should be between 3.25 mm and 7.0 mm.

The RX ACCUNET Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ 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 Embolic Protection System 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 is 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 change being made is to the formulation of an adhesive that is used to adhere two core subassemblies.

The provided text describes a 510(k) premarket notification for the RX ACCUNET Embolic Protection System and focuses on a change in adhesive formulation rather than a comprehensive study for initial device efficacy. Therefore, much of the requested information regarding clinical study design, ground truth, and reader studies is not present in this document.

However, based on the provided information, I can extract details about the acceptance criteria for the specific modification to this device and the study conducted to demonstrate that the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a modification to an already cleared device, the study described here is focused on demonstrating that the modification (adhesive reformulation) does not adversely affect the device's performance compared to its predicate and that it remains safe. It is not a study to establish initial clinical efficacy or standalone performance against a clinical ground truth.

Here's what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance: (See table above)

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

   • Sample Size: Not specified in the document. The testing described is in vitro bench testing. Typically, in vitro tests don't involve "patients" or "data provenance" in the same way clinical studies do. The samples would be device units or components.
   • Data Provenance: Not applicable in the context of in vitro bench testing of device components.

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/not provided because the described studies are in vitro bench tests (e.g., hypotube adhesion pull test), not clinical studies involving expert interpretation of medical data or images. The "ground truth" for a pull test is the physical outcome of the test (e.g., force at failure).

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

   • This information is not applicable/not provided as it pertains to expert consensus in clinical evaluations, which is not described here.

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:

   • This information is not applicable/not provided. The device is an Embolic Protection System, not an AI-powered diagnostic tool requiring human reader studies.

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

   • This information is not applicable/not provided. The device is a physical medical device (an Embolic Protection System), not a software algorithm.

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

   • For the in vitro bench testing, the "ground truth" would be the physical measurements and observations from the specific tests conducted (e.g., force measured in the hypotube adhesion pull test, laboratory results from biocompatibility assays). There is no clinical "ground truth" in this context.

8. The sample size for the training set:

   • This information is not applicable/not provided. This document describes the testing of a physical medical device modification, not the development or training of an AI algorithm.

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

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

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The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire 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 RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ 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™ Embolic Protection System 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 is a 510(k) premarket notification for the RX ACCUNET™ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study results with precise acceptance criteria and detailed performance data like a PMA (Premarket Approval) would.

Therefore, many of the requested elements for a detailed study description are not present in this document. The document explicitly states that "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System" and that the submission is for a "3 in 1 packaging configuration." The "Performance Data" section only mentions "packaging integrity studies."

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., specific sensitivity, specificity, accuracy thresholds). The overarching acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
• Reported Device Performance: The only performance data mentioned is related to "packaging integrity studies." No clinical performance metrics (like efficacy in embolic capture, complication rates, or patient outcomes) are provided for the device itself.

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

• Test Set Sample Size: Not applicable/not provided for clinical performance testing, as no new clinical study data on device performance is presented. The submission focuses on packaging changes and substantial equivalence.
• Data Provenance: Not applicable for clinical performance. The packaging studies would likely be internal Guidant testing.

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

• Not applicable, as no new clinical test set requiring expert ground truth establishment for device performance is described.

4. Adjudication Method for the Test Set

• Not applicable, as no new clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a TRMC study was not done, as this is solely a 510(k) submission for a packaging change, demonstrating substantial equivalence, not a new clinical study for effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a medical device (embolic protection system), not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable for clinical performance. For the packaging studies, the "ground truth" would be the verified integrity and sterility of the packaged device after testing.

8. Sample Size for the Training Set

• Not applicable, as no new clinical performance data or AI model training data is described.

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

• Not applicable.

Summary derived from the document:

The 510(k) K052166 for the RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration" is a submission demonstrating substantial equivalence to previously cleared predicate devices (RX ACCUNET™ Embolic Protection Systems K042218 and RX ACCUNET™ 2 Recovery Catheter K042908).

The document explicitly states:

• "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System."
• The "Technological Characteristics" are considered "substantially equivalent" in materials, biocompatibility, performance properties, sterilization, and packaging to the currently marketed predicate devices.

The only performance data mentioned are packaging integrity studies, which "demonstrated the safety and effectiveness of the proposed RX ACCUNET™ Embolic Protection System '3 in 1 packaging configuration.'" No details about these packaging studies (sample size, specific tests, acceptance criteria for packaging) are provided in this summary.

This 510(k) does not present a new clinical study to prove the device meets specific performance criteria beyond the existing predicate devices. The "study" referenced in the document is effectively the demonstration of substantial equivalence through comparison of technological characteristics and confirmation of packaging integrity for the new configuration.

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The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire 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 RX ACCUNET™ Embolic Protection System is a filtration type embolic protection system consisting of the RX ACCUNET™ Guide Wire, the RX ACCUNET™ Delivery System and the RX ACCUNET™ Recovery Catheter. The RX ACCUNET™ Embolic Protection System is 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 the Recovery Catheter. Once collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy

This document is a 510(k) summary for the RX ACCUNET™ Embolic Protection System. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/ML device.

The provided text focuses on demonstrating substantial equivalence of the RX ACCUNET™ Embolic Protection System to a legally marketed predicate device (K042218). This is a regulatory filing for a medical device that appears to be a physical device (embolic protection system) and not an AI/ML-driven software device. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained in this document.

The document discusses:

• Device Name: RX ACCUNET™ Embolic Protection System
• Intended Use: As a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) during angioplasty and stenting in carotid arteries, for artery diameters between 3.25 mm and 7.0 mm.
• Substantial Equivalence: The device is stated to be substantially equivalent to the RX ACCUNET™ Embolic Protection System (K042218) with minor design refinements to the filter basket end and additional in-process testing.

Without a study described in the provided text that evaluates the device against specific performance criteria (as would be typical for an AI/ML driven system), it is not possible to answer the questions about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement.

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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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