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The Emboshield® Embolic Protection System is 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 the Filtration Element placement should be between 2.8 mm and 6.2 mm.

The Emboshield® Embolic Protection System is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: RX BareWire™, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.

The provided text describes a 510(k) premarket notification for the "Emboshield® Embolic Protection System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving device performance against specific acceptance criteria. While a clinical study (SECuRITY Registry Trial) is mentioned, details about acceptance criteria, specific performance metrics, and study methodologies for those criteria are largely absent from this document.

However, based on the information provided, here's an attempt to answer the questions, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "device must achieve X accuracy with Y confidence"). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The general "acceptance criteria" are implied to be that the device is as safe and effective as the predicate device.

The reported device performance is broadly summarized as:

• "results of the testing and clinical study support the safety and performance of the Emboshield device and its components for the intended indication."

Missing Information: Specific quantitative acceptance criteria (e.g., % reduction in embolic events, % successful deployment, filtration efficiency) and the corresponding achieved performance values are not detailed in this document.

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

• Sample Size: The "SECuRITY Registry Trial" enrolled 399 patients.
• Data Provenance: The document does not explicitly state the country of origin. It mentions 30 sites, suggesting a multi-center study, but location is not specified. The trial name "Registry Trial" implies it's a prospective observational study, gathering data on standard clinical practice rather than a randomized controlled trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing Information: The document does not provide any information about the use of experts to establish a "ground truth" for the test set outcomes. Clinical trials typically rely on clinical endpoints (e.g., stroke rates, neurological deficits), which are evaluated by treating physicians and potentially adjudicated by independent clinical events committees, but the specifics are not mentioned here.

4. Adjudication method for the test set

Missing Information: The document does not describe any specific adjudication method for the test set outcomes.

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

Not Applicable: This device is an embolic protection system (a physical medical device), not an imaging or diagnostic AI device that would involve human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

Not Applicable: This is a physical device, not an algorithm or AI system. Its performance is evaluated through its mechanical function and clinical outcomes, not through "standalone algorithm performance."

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

The document implies that the ground truth for evaluating the device's safety and performance would be clinical outcomes data from the SECuRITY Registry Trial, likely pertaining to embolic events, device-related complications, and successful protection during procedures.

Missing Information: Specific details on how these clinical outcomes were defined and assessed (e.g., what constituted an embolic event, how it was diagnosed, etc.) are not provided.

8. The sample size for the training set

Not Applicable/Missing Information: This is a physical medical device. The concept of a "training set" is generally applicable to machine learning algorithms. While the device undergoes extensive R&D and engineering testing (which could conceptually be seen as "training" its design), there isn't a "training set" in the machine learning sense for its clinical application. If the question implies prior data used to inform the device design or predicate device data synthesis, that detail isn't provided.

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

Not Applicable/Missing Information: As mentioned above, the concept of a "training set" in the context of an algorithm's ground truth is not directly applicable to a physical device like this.

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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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