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The GuardWire Temporary Occlusion and Aspiration System is indicated for use in carotid arteries to:

• . Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures.
• . Facilitate placement and use of diagnostic or therapeutic catheters using the GuardWire Temporary Occlusion Catheter.
• . To locally infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• . The diameter of the artery where the occlusion balloon is placed should be between 3 and 6 mm.

The GuardWire® Temporary Occlusion and Aspiration System is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the EZ Adaptor device, the Export® Catheter, and the EZ Flator Inflation device.
The GuardWire Temporary Occlusion Catheter is a "balloon-on-a-hypotube-wire" catheter with a distal elastomeric occlusion balloon. It has a lubricious coating and a flexible radiopaque tip. The GuardWire Temporary Occlusion Catheter is packaged with an Introducer Sheath, an EZ Adaptor device, and an EZ Flator Inflation Device. The EZ Adaptor device is used exclusively with the GuardWire Temporary Occlusion Catheter for the purpose of controlled volumetric inflation and deflation of the temporary occlusion balloon.
The EZ Flator device is used exclusively with the GuardWire Temporary Occlusion Catheter during catheter preparation, inflation and deflation of the balloon. The EZ Flator device delivers a controlled volume when inflating the balloon to each occlusion size. It has an integrated deflation syringe used for catheter preparation and balloon deflation and has a reservoir for diluted contrast solution.
The Export Catheter is compatible with the GuardWire Temporary Occlusion Catheter and has a distal radiopaque tip marker and proximal Luer-lock port.

Here's the information about the acceptance criteria and the study for the GuardWire® Temporary Occlusion and Aspiration System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide specific numerical performance metrics for the device against particular criteria. Instead, it states that "The safety and performance of the GuardWire 3-6 Temporary Occlusion and Aspiration System for use in carotid arteries is supported by the MAVErIC I & II clinical trials."

Therefore, I cannot populate a table with specific acceptance criteria and numerical performance results based on this document. The approval seems to be based on the general safety and effectiveness demonstrated in the clinical trials, and substantial equivalence to predicate devices, rather than meeting predefined quantitative targets reported in the summary.

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

The document mentions supporting clinical trials (MAVErIC I & II) but does not specify the sample size for these trials, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) submission for a new device, it is highly probable that the data would be prospective, but this is not explicitly stated.

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

The document does not provide any information regarding the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. It focuses on the device's performance through clinical trials (MAVErIC I & II) but not on comparing human readers with and without AI assistance.

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

This device is a physical medical device (a catheter system), not an AI algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. Its performance is assessed through its physical interaction within the human body during procedures.

7. Type of Ground Truth Used

Given that this is a physical medical device used in interventional procedures, the "ground truth" for assessing its safety and effectiveness in the MAVErIC I & II clinical trials would likely involve clinical outcomes data related to its intended use, such as:

• Incidence of embolic material containment and aspiration.
• Successful facilitation of diagnostic/therapeutic catheter placement.
• Successful local infusion/delivery of agents.
• Adverse event rates (e.g., stroke, vessel injury).
• Procedural success rates.

However, the document does not explicitly state the specific endpoints or "ground truth" criteria used in the MAVErIC I & II trials.

8. Sample Size for the Training Set

This device is a physical medical device, not an AI algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As this is not an AI algorithm, the concept of a "training set" and establishing its ground truth is not applicable.

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The GuardWire 3-6 Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

• · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

The GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in coronary saphenous bypass grafts. The system is used to contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures and is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal® Adapter and the Export® Aspiration Catheter and the EZ Flator Inflation Device. The GuardWire may also be used during these procedures alone or in conjunction with the Export Catheter to locally infuse diagnostic or therapeutic agents with or without vessel occlusion. The modification to the GuardWire system addressed with this submission entails the introduction of the EZ-Adapter as a replacement for the MicroSeal Adapter (MSA), as the device that actuates the MicroSeal of the GuardWire device. Both the EZ Adapter and the MicroSeal Adapter provide the same mechanical functions: hold the GuardWire in a static fixed position, actuate, through linear movement, the MicroSeal plug system of the GuardWire, and provide direct communication from the EZ Flator inflation device to the GuardWire balloon to facilitate inflation or deflation of the GuardWire balloon.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GuardWire Temporary Occlusion and Aspiration System, focusing on the EZ-Adapter modification:

This submission (K023878) concerns a modification to an existing device, the GuardWire Temporary Occlusion and Aspiration System. The core of this submission is the replacement of the MicroSeal Adapter (MSA) with a new component called the EZ-Adapter.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the EZ-Adapter. Instead, the basis for clearance is substantial equivalence to the predicate device's component (MicroSeal Adapter). The primary "acceptance criteria" appear to be functional equivalence and equivalent manufacturing.

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

The document states: "The EZ Adapter has been subjected to performance testing and it has been determined that the EZ Adapter is substantially equivalent to the MicroSeal Adapter." However, no specific details regarding the sample size used for this testing are provided. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. Given the nature of a component replacement and the focus on functional equivalence, this testing would likely be bench testing rather than clinical data from human subjects.

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

This information is not provided in the document. For a 510(k) submission based on substantial equivalence of a component, the "ground truth" is primarily established through engineering and performance testing against defined specifications and comparison to the predicate component's known performance. Expert clinical input might be involved in defining the functional requirements, but there's no mention of a formal expert panel to establish ground truth for a test set in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Since the "test set" and "ground truth" in the typical sense of clinical trials or AI/diagnostic device evaluation are not explicitly described, an adjudication method is not mentioned and is likely not applicable in this context. The evaluation would have been based on direct measurement and engineering comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving human interpretation) to assess the impact of a device on reader performance. The GuardWire system and its EZ-Adapter component are interventional medical devices, and the submission focuses on functional equivalence of a mechanical component, not human interpretational effectiveness.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" (usually for an algorithm) also does not apply here. The EZ-Adapter is a physical component of a medical device intended for use in an interventional procedure by a clinician. Its "performance" is inherent to its mechanical function, not an algorithm's output. The performance testing would have evaluated the physical attributes and operational capabilities of the EZ-Adapter.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications, functional requirements, and direct comparison to the performance of the predicate MicroSeal Adapter. The document emphasizes "functional equivalence," "similar processes and equivalent materials," and "performance testing" to determine substantial equivalence. This is not derived from expert consensus, pathology, or outcomes data in the way a diagnostic device's ground truth would be.

8. The Sample Size for the Training Set

No training set is mentioned or applicable for this type of device modification. Training sets are relevant for machine learning or AI algorithms, which are not involved in the EZ-Adapter.

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

As there is no training set and no AI component, this question is not applicable.

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The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

• Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter. The GuardWire Plus System is a sterile, single use disposable device.

Here's a breakdown of the acceptance criteria and study information for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are derived from the "Non Clinical Performance Data Summary" and "Clinical Performance Data (SAFER Study Data Results Summary)" sections.

Disclaimer: The document does not explicitly list quantitative "acceptance criteria" in a structured table. Instead, it describes objectives and conclusions for the performance studies. The table below synthesizes these objectives/conclusions as the de-facto acceptance criteria and reports the device's demonstrated performance.

Study Details

This device is not an AI/ML powered device, so some of the questions (e.g., about experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set) are not directly applicable. However, I will provide the closest relevant information from the provided text.

1. Sample sizes used for the test set and the data provenance:

   • Main Clinical Study (SAFER Study - Randomized Controlled Trial):

     • Test Set (GuardWire™ group): 406 patients, 442 lesions.
     • Control Set (No GuardWire™ group): 395 patients, 433 lesions.
     • Total Randomized: 801 patients, 875 lesions.
     • Data Provenance: Not explicitly stated, but likely multi-national as it refers to a "randomized study". These are generally prospective in nature.

   • Feasibility 1 - Single Center Experience:

     • Test Set: 20 patients, 24 procedures, 30 lesions.
     • Data Provenance: Single center (St. Paul's Hospital, Vancouver, B.C., Canada). This was a prospective registry.

   • Feasibility 2 - Multi-Center Experience (SAFE Study):

     • Test Set: 103 patients, 105 lesions.
     • Data Provenance: Multi-center prospective non-randomized consecutive pilot trial. Ten sites utilized in Canada, Germany, and Italy.

   • Non-Clinical Performance Studies:

     • Vessel Occlusion & Fluid Evacuation & Particle Evacuation & Infusion Flow Rate: In-vitro studies, not patient data. Sample sizes for these components (e.g., number of tests performed) are not specified.
     • Additional Laboratory Studies (Aspirates): 40 aspirates. Origin is not explicitly stated but implies human clinical procedures.
     • Animal Studies: 8 separate animal safety and effectiveness studies, plus 4 additional animal comparative studies.

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

   • Clinical Studies: The clinical outcomes (e.g., MACE, MI, etc.) are typically established by clinical events committees (CEC) and/or site investigators based on predefined clinical endpoints and diagnostic criteria.
     • The SAFE Study mentions "independent data analysis for this study was conducted by CDAC-Cardiovascular Data Analysis Center, Beth Israel Deaconess Medical and Harvard Medical Centers" and "independent investigational site monitoring was conducted by MedPass International of Paris, France."
     • The definition of In-Hospital/Out-of-Hospital MACE states "as determined by the independent Clinical Events Committee."
   • Qualifications: While the specific number and qualifications of individual experts on these committees are not detailed, in clinical trials, such committees are typically composed of experienced clinicians (e.g., cardiologists) specialized in the relevant field.
   • Non-Clinical Studies: The "PercuSurge Medical Advisory Board" was involved in establishing minimum specifications for fluid and particle evacuation, indicating expert input on these non-clinical performance metrics.

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

   • For the clinical studies, an "independent Clinical Events Committee" was responsible for determining MACE outcomes. While the specific adjudication method (e.g., how disagreements were resolved) is not detailed (e.g., 2+1), the existence of such a committee implies a structured review process.

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:

   • This is not an AI/ML powered device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable and was not performed. The SAFER study was a randomized controlled trial comparing the device (GuardWire™) with standard care (No GuardWire™). The effect size of the GuardWire system on MACE reduction was a decrease from 16.5% (No GuardWire) to 9.6% (GuardWire).

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

   • This is a medical device, not an algorithm. Therefore, "standalone" performance in the AI context isn't applicable. The device's performance is inherently tied to its use by a human interventional cardiologist. The non-clinical studies (e.g., vessel occlusion, fluid/particle evacuation) demonstrate components' "standalone" functional performance.

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

   • Clinical Studies (SAFER, Feasibility 1 & 2): Ground truth was established using clinical outcomes data (e.g., death, myocardial infarction, revascularization events) assessed by an independent Clinical Events Committee based on predefined diagnostic criteria.
   • Non-Clinical Studies: Ground truth for these was based on physical measurements and engineering specifications (e.g., achieving occlusion, flow rates, percentage of particles evacuated), often guided by input from the "PercuSurge Medical Advisory Board."
   • Animal Studies: Ground truth included histopathology results (evaluating vessel effects) and functional performance observed during procedures (occlusion, fluid delivery/evacuation).
   • Additional Laboratory Studies (Aspirates): The "nature of the material and its cellular component" implies laboratory analysis of the aspirate content.

7. The sample size for the training set:

   • This is not an AI/ML powered device, so there is no "training set" in that context. The development and iterative design improvements of the device would have been informed by the "8 separate animal safety and effectiveness studies" and "Four additional animal comparative studies," as well as "physician input," which could be considered analogous to iterative "training" feedback in a conventional development cycle.

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

   • Not applicable as it's not an AI/ML device with a formal training set. The "ground truth" for the iterative development and modification of the device (GuardWire Plus design improvements) was established through animal studies and qualitative "physician input" on performance and ease of use.

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