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The AZUR system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, atteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The Detachable AZUR HydroPack 18 Peripheral Coil System with a controlled detachable delivery method consists of an implantable coil, a delivery pusher, and a Detachment Controller (sold separately). The implantable coils are made of platinum alloy with a hydrogel inner core. The coil is attached to the delivery pusher via a polyolefin elastomer filament. The coil implant is delivered to the target treatment site through a microcatheter which has an inner dimension that is compatible with the selected AZUR HydroPack 18 Peripheral Coil System. The proximal end of the delivery pusher is inserted into the hand-held battery powered AZUR Detachment Controller. When the implantable coil has been successfully placed in the desired location, the AZUR Detachment Controller is activated and a flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The AZUR Detachment Controller is packaged and sold separately.

The provided text describes a 510(k) premarket notification for a medical device, the AZUR HydroPack 18 Peripheral Coil System (Detachable). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical or comparative effectiveness studies in the same way an AI/ML device might.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and even ground truth for training sets) are not applicable to this type of device clearance and submission. The performance data presented here is focused on engineering verification and validation of the device's physical properties and function.

Here's a breakdown of the available information:

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

The document does not explicitly list acceptance criteria values alongside reported device performance values. Instead, it states that testing was performed "to ensure that the modified device continues to meet the established design and performance specifications." The categories of tests performed are listed as the performance data.

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

This information is not provided in the summary. The tests are engineering verification and validation (V&V) tests, typically performed in a lab setting rather than clinical studies with human data.

3. 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)

This is not applicable. Ground truth in the context of this device's V&V testing refers to engineering specifications and performance expectations, not clinical expert consensus on diagnostic or therapeutic outcomes.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. For engineering tests, results are typically measured against predefined limits and specifications.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive devices, which is not the case for this physical medical device.

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

This is not applicable. This is a physical vascular embolization device, not an algorithm or AI system.

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

The "ground truth" for the device's performance is its established design and performance specifications. For example, a "visual and dimensional inspection" test would have specifications for dimensions, and the ground truth would be those specified dimensions.

8. The sample size for the training set

This is not applicable. Training sets are used for AI/ML algorithms. This device underwent engineering verification and validation.

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

This is not applicable. As no training set was involved (this is not an AI/ML device), no "ground truth for the training set" was established.

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The ERIC Retrieval Device is indicated to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke. The device consists of retrieval spheres secured on a pusher wire that are designed to capture and remove blood clots from the neurovasculature. The device is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the ERIC Retrieval Device:

I. Acceptance Criteria and Reported Device Performance

II. Sample Size and Data Provenance (Clinical Study)

• Sample Size for Test Set:
  • ERIC Device Cohort: N = 206 patients
  • Trevo/Solitaire Cohort: N = 1058 patients
• Data Provenance: Prospective, multi-center, observational study (ETIS - Endovascular Treatment in Ischemic Stroke follow-up Evaluation Observational Cohort Study, NCT03776877). Data collected from all 7 active sites from the beginning of the study to September 2018.
• Country of Origin: France.
• Retrospective or Prospective: Prospective.

III. Number of Experts and Qualifications (Clinical Study Ground Truth / Patient Selection)

• "All patients were selected for endovascular thrombectomy based on evaluation by a multi-disciplinary team of physicians including neuroradiologists."
• Number of Experts: Not explicitly stated, but implies a team approach.
• Qualifications of Experts: Included "neuroradiologists." Specific years of experience are not mentioned.

IV. Adjudication Method (Clinical Study Test Set)

• The document does not explicitly describe an adjudication method for the test set outcomes (mTICI, sICH, mRS). This was an observational study based on data collected over time. Outcomes would have been determined by the treating physicians and documented in the study records.

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

• No, a MRMC comparative effectiveness study was not done. The clinical study compared the performance of the ERIC device against predicate devices (Trevo/Solitaire) in terms of patient outcomes (reperfusion rates, sICH, mRS) as measured in standard clinical practice, not specifically assessing the improvement of human readers with AI assistance. This device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

VI. Standalone (Algorithm Only) Performance

• Not applicable. This device is a medical device (mechanical thrombectomy device), not an algorithm or AI. The performance metrics presented are for the device's clinical efficacy and safety when used by medical professionals, not a standalone algorithm.

VII. Type of Ground Truth Used (Clinical Study)

• Clinical Outcomes/Expert Assessment and Imaging:
  • Successful reperfusion (mTICI 2b-3): Based on angiographic imaging assessed by clinical experts (likely neuroradiologists or interventionalists within the clinical setting).
  • Symptomatic Intracerebral Hemorrhage (sICH): Based on clinical assessment and follow-up CT scan/MRI, interpreted by medical professionals.
  • Good Clinical Outcome (90-day mRS 0-2): Modified Rankin Scale (mRS) score assessed clinically by medical professionals at 90 days.

VIII. Sample Size for Training Set

• Not applicable. The ERIC Retrieval Device is a hardware medical device, not an AI/ML algorithm that requires a training set. The clinical study investigated its performance against established predicate devices.

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

• Not applicable. As described above, there is no training set for this type of hardware medical device.

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The Traxcess™ 14 SELECT Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

The Traxcess™ 14 SELECT Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil. The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician. The coil section of the guidewire and the distal stainless-steel section is coated with a hydrophilic coating, while the proximal stainless-steel section is coated with PTFE. The purpose of these surface coatings is to provide lubricity when the Traxcess™ 14 SELECT guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.

The provided text describes the acceptance criteria and a study demonstrating that the Traxcess™ 14 SELECT Guidewire meets these criteria. However, it's important to note that this document is for a medical device (guidewire), not an AI/ML powered device. Therefore, many of the requested categories (e.g., ground truth, experts, MRMC study, training set) typically associated with AI/ML device performance evaluation are not applicable or found in this context.

Here's the information extracted from the document:

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

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

The document mentions "Test articles" for bench testing and "animals" for biocompatibility testing, but does not specify the exact sample sizes for each test. The provenance of the data is that it was generated from verification and validation testing on the Traxcess™ 14 SELECT Guidewire. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective.

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 as the document describes a physical medical device (guidewire) and its performance through bench and biocompatibility testing, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

This information is not applicable for the reasons stated above. The tests performed are objective laboratory assessments.

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 as the document describes a physical medical device (guidewire), not an AI/ML device that assists human readers.

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

This information is not applicable as the document describes a physical medical device (guidewire), not an AI/ML device.

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

The "ground truth" for this device's performance is based on objective measurements and observations against established specifications and ISO standards for physical and biological properties. This includes dimensional measurements, visual inspection for defects, force resistance, coating integrity, and specific biological responses (e.g., cell viability, immune response, blood compatibility).

8. The sample size for the training set:

This information is not applicable as the document describes a physical medical device and its validation through testing, not an AI/ML device that requires a training set.

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

This information is not applicable for the reasons stated above.

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The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

The AZUR Vascular Plug consists of an AZUR vascular occlusion plug implant that is attached to a delivery wire which is intended to be delivered to the treatment site through a microcatheter.

The AZUR Vascular Plug implant is an embolization device consisting of a conformable, self-expanding nitinol braided wire frame surrounding a flexible, occlusive membrane. The implant comes in three sizes, small (5 mm), medium (8 mm) and large (10 mm). The implant is deployed in an appropriately sized vessel to reduce or block the flow of blood. The implant has radiopaque markers to provide visual confirmation of deployment location during the interventional treatment. The implant is delivered through a microcatheter on a detachable delivery system.

The delivery wire attached to the AZUR Vascular Plug implant is 185cm in length and an outer diameter suitable for delivery through a 0.027" ID microcatheter.

A detachment controller powers the delivery pusher to detach the implant. The microcatheter and the detachment controller are provided separately.

The provided text is a 510(k) premarket notification for a medical device called the AZUR Vascular Plug. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy through clinical trials with strict acceptance criteria and performance data in the way a new drug or a novel AI diagnostic device might.

Therefore, the typical structure for detailing "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested, particularly regarding "device performance" in terms of accuracy, sensitivity, or specificity, and the involvement of "experts" for "ground truth," "MRMC studies," or "standalone performance" metrics, does not directly apply to this document. This document is about device safety and technological equivalence, not clinical performance analysis of an AI model or diagnostic tool.

However, I can extract and infer information from the provided document to answer as many of the requested points as possible, focusing on what constitutes "acceptance criteria" and "proof" within the context of a 510(k) submission for a vascular plug.

Here's how to interpret the request in the context of the provided document:

• "Acceptance criteria" and "reported device performance": For a vascular plug, these relate to its physical and functional characteristics (e.g., ability to obstruct blood flow, detach reliably, biocompatibility, mechanical integrity). The "proof" comes from an array of non-clinical (bench and animal) tests, not typically from human clinical outcomes data as you'd see for an AI diagnostic.
• "Ground truth": This is established by the design specifications and the results of the physical and chemical tests, rather than expert labels on medical images.
• "Multi-reader multi-case (MRMC) comparative effectiveness study": This is not applicable to a physical device like a vascular plug. This type of study is for evaluating the impact of a diagnostic tool (often AI-assisted) on human reader performance.
• "Standalone (i.e., algorithm only without human-in-the-loop performance)": Again, not applicable as this is not an algorithm or AI device.
• "Training set": Not applicable as there is no AI model being trained.

Based on the provided K191680 document for the AZUR Vascular Plug, here is an interpretation of the requested information:

This 510(k) submission demonstrates substantial equivalence to a predicate device, the Medtronic Micro Vascular Plug (K150108), rather than proving clinical efficacy or diagnostic performance through human studies with strict acceptance criteria. The "acceptance criteria" and "performance" are framed in terms of the device's physical, chemical, and mechanical properties, and its ability to function as intended in non-clinical settings.

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a vascular plug, "acceptance criteria" are the predefined specifications and thresholds for its physical, mechanical, and biocompatibility properties, and "reported device performance" refers to the results of the tests conducted to demonstrate that these criteria are met.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in terms of number of plugs or specific quantities for each test. The document states "a number of animal studies" and lists "Porcine large animal study" and "Intramuscular implant rabbit study." For bench testing, it lists types of tests but not the quantity of devices tested.
• Data Provenance: The studies were internal to MicroVention Inc. and likely conducted at contracted labs. The document does not specify a country of origin for the data or whether the studies were retrospective or prospective, but these would inherently be prospective non-clinical (bench and animal) studies for regulatory submission purposes.

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

• Not Applicable in the traditional sense. For a physical device, "ground truth" is established by the design specifications, material properties, and objective measurements from bench and animal studies. There isn't a need for multiple human experts to establish "ground truth" through interpretation (e.g., reading images).
• However, the document mentions a "physician usability study" in relation to the detachment system. While not an "expert ground truth" for performance metrics like sensitivity/specificity, it implies the involvement of physicians in evaluating a functional aspect of the device. The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, typically in diagnostic imaging studies. This is not relevant to the evaluation of a physical medical device like a vascular plug based on bench and animal testing.

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

• No, not done. This type of study is specifically designed for evaluating diagnostic tools (often AI-assisted systems) and their impact on human reader performance. It is not applicable to a physical vascular plug.

6. Standalone (Algorithm Only) Performance Study

• No, not done. This concept is only relevant for AI algorithms or diagnostic software. The AZUR Vascular Plug is a physical medical device.

7. Type of Ground Truth Used

• For Biocompatibility: Established by adherence to ISO 10993 standards and direct laboratory measurements of biological responses to materials.
• For Mechanical/Functional Performance: Established by engineering specifications, direct physical measurements (e.g., tensile strength, radial force), and observation of functional success/failure in controlled bench and simulated use environments.
• For In-Vivo Performance: Established by histological analysis, physiological observations, and procedural success/failure in animal models as per pre-defined animal study protocols.

In essence, the "ground truth" is derived from rigorous, objective, and reproducible scientific and engineering test results against pre-defined specifications.

8. Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI model requiring a training set.

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

• Not Applicable. As there is no training set, there is no ground truth to establish for one.

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The Scepter Mini Occlusion Balloon Catheter is intended:

For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

Scepter Mini Occlusion Balloon Catheter is a dual co-axial lumen balloon catheter. The catheter is designed to track over a steerable guidewire. The outer lumen is used for the inflation of the balloon independent of guidewire position. The inner lumen can be used to deliver diagnostic agents or liquid embolics to distal locations in tortuous anatomy. Radiopaque marker bands are located at each end of the balloon to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheter is packaged sterile for single use only.

The Scepter Mini has similar indications for use as the predicates, however, incorporates several minor design differences. The Scepter Mini has a slightly longer length and a slightly smaller diameter. The balloon of the Scepter Mini is slightly shorter. The distal tip of the Scepter Mini extends a shorter distance from the distal end of the balloon than that of the Scepter C and XC. For the Scepter Mini, the purge hole is covered by a semi-permeable membrane designed to allow air to escape while preventing liquids from passing. The predicate Scepter C and XC incorporate 3 radiopaque marker bands, while the design of the Scepter Mini allows for visualization under fluoroscopy with only 2 radiopaque marker bands (due to shorter distal tip segment). All Scepter catheters have a hydrophilic coating.

This document is a 510(k) Pre-market Notification for the Scepter Mini Occlusion Balloon Catheter, seeking to demonstrate its substantial equivalence to previously cleared predicate devices. The study detailed is a set of verification and validation tests, and a summary of an animal study, used to support this claim.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive table of "Verification Test Summary" where each test description implicitly defines the acceptance criteria by stating the desired outcome (e.g., "does not break," "does not leak," "pass") and then reports that the subject device "Pass"ed. For many tests, it explicitly states that the device "meets the same specification as predicates Scepter C/XC (K121785)."

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

• Verification Tests: The document doesn't explicitly state the sample sizes for each individual mechanical or physical verification test. However, it indicates these tests were performed on the "subject device" (Scepter Mini Occlusion Balloon Catheter). The provenance of this data is MicroVention, Inc.'s internal testing/laboratories. This data is likely prospective, generated specifically for this submission.
• Animal Study (In Vivo Testing): The animal study used for the "In Vivo Testing" was performed using the predicate device Scepter C in an "acute swine animal model." The exact number of swine used is not explicitly stated in this summary, but it implies multiple animals ("compared with a commercially equivalent device"). The data provenance is from this predicate device study. This would be prospective data for the predicate, but retrospective in its application to the subject device.

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

• The document does not mention expert involvement in establishing ground truth for the mechanical, physical, or biocompatibility tests. These are objective, quantitative tests with defined pass/fail criteria.
• For the animal study, the "histopathologic evaluation" implies assessment by a qualified pathologist. However, the exact number of experts or their specific qualifications (e.g., "veterinary pathologist with X years of experience") are not specified in this summary.

4. Adjudication Method for the Test Set:

• For the technical verification tests, the results are objective (numerical values meeting specifications, or physical observations like "no leak," "no break"). An adjudication method is not applicable in the sense of expert consensus on ambiguous findings, as the tests produce clear pass/fail outcomes against predefined criteria.
• For the animal study's histopathologic evaluation, it's not specified if multiple pathologists reviewed slides or if an adjudication method was used for discrepancies.

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:

• No MRMC study was performed. This submission is for a physical medical device (balloon catheter), not an artificial intelligence (AI) or software as a medical device (SaMD) that typically relies on human reader performance. Therefore, there is no AI component, and no effect size regarding human reader improvement with AI assistance is relevant or reported.

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

• Does not apply. This is a physical medical device; there is no AI algorithm to evaluate.

7. The Type of Ground Truth Used:

• Verification Tests (Mechanical, Physical, Chemical): The ground truth for these tests is based on engineering specifications, industry standards (e.g., ISO), and regulatory requirements (e.g., USP). These are objective, measurable outcomes.
• Biocompatibility Tests: Ground truth is established based on pre-defined biological responses (e.g., lack of cytotoxicity, non-irritating, non-pyrogenic) as per ISO 10993-1:2009 and FDA guidelines.
• Animal Study (In Vivo Testing): The ground truth for the efficacy and safety during the in-vivo performance characteristics and histopathology evaluation is based on direct observation in the animal model and subsequent pathological examination of tissues for injury or adverse events. This could be considered pathology and in-vivo observational data.

8. The Sample Size for the Training Set:

• Does not apply. This is a physical medical device, not a machine learning model; therefore, there is no "training set."

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

• Does not apply. There is no training set for this type of device submission.

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