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The Wedge XL Delivery Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

The Wedge XL Delivery Catheter is a single lumen catheter designed to be introduced over a steerable quidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Radiopaque markers at the distal end facilitate fluoroscopic visualization. A larger diameter distal segment helps provide stability for navigation. The distal 110 cm outer surface of the Wedge XL Delivery Catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Wedge XL Delivery Catheter hub is used for the attachment of accessories.

This document describes the regulatory approval of the MicroVention, Inc. Wedge XL Delivery Catheter (K232542) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance data in the typical format of a clinical trial for an AI/software device.

The information provided confirms that the device is a percutaneous catheter, not an AI/software as a medical device (SaMD). Therefore, the questions regarding acceptance criteria and performance studies specifically for AI/Software (e.g., test set, ground truth, expert adjudication, MRMC studies) are not directly applicable in the format requested.

However, I can extract the information relevant to the device's performance testing and general acceptance:

The submission demonstrates the device meets acceptance criteria through a series of bench testing and an animal study, alongside biocompatibility evaluation and sterilization information. The overall acceptance criterion is substantial equivalence to the predicate device (Wedge Microcatheter K172014) and a reference device (Delivery Catheter of the Route 92 Medical 088 Access System K200121).

Here's a breakdown of the provided information within the context of a medical device submission:

Acceptance Criteria and Reported Device Performance (Table Format - Adapted for a Non-AI Device):

For the points specifically pertaining to AI/ML device studies, the following is direct or inferred from the document:

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

   • This is not an AI/ML device. For bench testing, samples are typically physical units. For the animal study, it mentions a "porcine model," implying a number of animals were used, but the specific count is not provided. The study followed GLP (Good Laboratory Practice) Regulation (21 CFR Part 58), indicating a controlled, prospective study. The origin is a "porcine model," which is not human data.

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

   • Not applicable as this is not an AI/ML device. Ground truth for device performance would be established through physical measurements, chemical analyses, and histopathological evaluation by trained personnel (e.g., lab technicians, pathologists) in the animal study, but the specific number and qualifications are not detailed beyond "Good Laboratory Practice (GLP)".

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

   • Not applicable as this is not an AI/ML device.

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 as this is not an an AI-driven or diagnostic device that involves human reader interpretation.

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

   • Not applicable. This is a physical medical device.

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

   • For bench testing: Physical measurements, performance metrics based on engineering and material science standards.
   • For biocompatibility: Laboratory assays with established controls and reference standards.
   • For the animal study: Pathology (histological impact on arterial sections, postmortem examination for gross findings), and outcomes data (safety and performance of catheter tracking, vascular response to device use).

8. The sample size for the training set:

   • Not applicable as this is not an AI/ML device that requires a training set.

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

   • Not applicable.

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The SOFIA EX Intracranial Support Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA EX Intracranial Support Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA EX Intracranial Support Catheter is not intended for use in coronary arteries.

The SOFIA™ EX Intracranial Support Catheter is a single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier Tyvek pouch and placed in a carton box.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroVention, Inc. SOFIA EX Intracranial Support Catheter:

Summary of Acceptance Criteria and Device Performance for SOFIA EX Intracranial Support Catheter (K230775)

The provided document describes the SOFIA EX Intracranial Support Catheter as being substantially equivalent to its predicate device (SOFIA EX Intracranial Support Catheter, K182602). This means that the acceptance criteria and performance are largely benchmarked against the predicate device, implying similar performance expectations.

The document focuses on bench testing to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of catheters tested for simulated use, kink resistance, or particulate testing). The data provenance is bench testing, meaning it was conducted in a laboratory setting, not on patient data. No country of origin for the data is specified, but it can be assumed to be related to MicroVention, Inc.'s operations, likely within the US, given the FDA submission. The nature of the testing is prospective in the sense that new samples of the subject device were manufactured and tested according to a predefined protocol.

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

Not Applicable (N/A) for this submission. The ground truth for these bench tests is based on objective measurements and predefined engineering specifications, not expert interpretation of diagnostic data.

4. Adjudication Method for the Test Set

Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or agreement on outcomes. Bench tests rely on precise measurements and adherence to specifications.

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

No. The document explicitly states: "No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes." Therefore, no MRMC study was performed, and no human reader improvement effect size is available.

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

Not Applicable (N/A). This device is a medical catheter, a physical product, not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used

The ground truth for the bench tests is based on objective engineering measurements and predefined specifications. For example:

• Simulated Use/Lubricity: Successful navigation through a tortuous model, visual inspection for damage, and measurement of friction/lubricity metrics.
• Kink Resistance: Mechanical testing to observe and quantify resistance to kinking under specified bending conditions.
• Particulate Testing: Quantitative measurement of particle count and size using standard laboratory methods.
• Biocompatibility: Demonstrated through adherence to ISO 10993-1 standards, which were previously met by the predicate device (same materials, processing, sterilization).

8. Sample Size for the Training Set

Not Applicable (N/A). This is a medical device, not an AI/ML algorithm. There is no "training set" in the context of this submission. The device's design is based on engineering principles and validated through bench testing, not machine learning.

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

Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question does not apply.

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The EmPro™ EPS/Nanoparasol™ EPS is indicated for use as a guidewire 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 filter placement should be between 3.0 and 6.5 mm.

MicroVention's Embolic Protection System (EPS) is marketed under two names: EmPro™ Embolic Protection System and Nanoparasol™ Embolic Protection System. The Embolic Protection System (EPS) is designed to capture and remove dislodged debris during a carotid interventional procedure. It consists of three basic components and additional accessories:

1. An Embolic Protection Device (EPD) consisting of a nitinol braided mesh filter with an atraumatic distal tip built on an integrated .014" PTFE coated stainless steel capture delivery wire.
2. A 3.5F delivery catheter with 150 cm length.
3. A 5F retrieval catheter with 150 cm working length. Accessories include a wire introducer, EPD loading cover, sheath introducer and a torque device. Catheters are provided in two separate dispenser coils.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the EmPro™ EPS/Nanoparasol™ EPS. This device is an embolic protection system indicated for use as a guidewire to contain and remove embolic material during angioplasty and stenting procedures in carotid arteries.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Study (Test Set): 256 patients (n=256) in the Intent-To-Treat (ITT) population.
• Data Provenance: The study was a "multicenter, single-arm, interventional study" called the CONFIDENCE study (IDE G140249). While the specific countries are not mentioned, FDA submissions typically involve studies conducted in the US or under equivalent international standards. The study design is prospective.
• Sample Size for Animal Study: 6 animals (porcine model).

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study's endpoint definitions (MAE, technical success). Clinical trials typically involve a clinical events committee (CEC) composed of expert physicians to independently adjudicate events like death, stroke, and MI, but this level of detail is not provided in this regulatory summary.

For the animal study, the document mentions "histological analysis" and "neurological assessments" were performed, implying expert evaluation, but the number and specific qualifications of the experts are not detailed.

4. Adjudication method for the test set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the clinical study's primary and secondary endpoints. For a multi-center clinical study with composite endpoints like MAE, it is standard practice to have a Clinical Events Committee (CEC) adjudicate events, often with multiple readers and a pre-defined adjudication process, but the specifics are not provided 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an embolic protection system, not an AI-powered diagnostic tool, so such a study would not be applicable. The performance evaluated relates to the mechanical and clinical outcomes of the device itself and its ability to capture emboli, not human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (an embolic protection system), not an algorithm or AI system. Its performance is evaluated in vivo (animal and human clinical studies) and in vitro (bench testing), not as a standalone algorithm.

7. The type of ground truth used

• Clinical Study (CONFIDENCE study): The ground truth for the primary endpoint (MAE) was based on clinical outcomes: death, stroke, and myocardial infarction (MI), confirmed by medical records and follow-up. For secondary endpoints like technical success (e.g., EPS successfully inserted, deployed, retrieved), the ground truth would be based on procedural observations and documentation. This represents outcomes data and procedural success data.
• Animal Study: Ground truth was established through direct observation during intervention (e.g., tracking, deployment, retrieval), post-intervention assessment (thrombus formation, particulate capture, device damage, neurological dysfunction), and post-explantation histopathology/histology to evaluate tissue response.

8. The sample size for the training set

This document does not describe a "training set" in the context of an AI/ML model. The studies described are for the validation and performance evaluation of a physical medical device. Therefore, a training set sample size, as understood in AI/ML development, is not applicable or provided.

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

As there is no mention of a "training set" for an AI/ML model, this question is not applicable. The device's design and engineering would have been informed by a vast amount of existing medical knowledge, material science, and prior device development, rather than a specific "training set" with established ground truth in the AI/ML sense.

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The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.

The ISAAC™ Neurovascular Navigation Catheter) is a braid-reinforced variable stiffness catheter with a pre-shaped distal segment. The distal end of the catheter is coated with a hydrophilic coating around the curve of the pre-shaped section of the Simmons (SIM) configuration. It is a single lumen catheter with a radiopaque distal coiled section and a Luer hub on the proximal end. The ISAAC Catheter is sterile, non-pyrogenic and intended for single use only.

The FDA 510(k) summary for the MicroVention, Inc. ISAAC Neurovascular Navigation Catheter (K222115) indicates that a range of performance testing was conducted to demonstrate the device's substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Benchtop and Biocompatibility Testing: The specific sample sizes for each individual benchtop and biocompatibility test are not explicitly detailed in this summary. However, these tests are generally conducted on a statistically significant number of device units or material samples to ensure representativeness and reproducibility.
• Animal Study: The animal study was conducted using a "porcine model." The exact number of animals involved is not specified, but it's referred to as an "acute animal testing" in a "porcine model."
• Data Provenance:
  • Benchtop Testing: Likely laboratory-generated data from MicroVention, Inc., performed under controlled conditions.
  • Biocompatibility Testing: Performed on material extracts or the device itself, likely by specialized laboratories following ISO standards.
  • Animal Study: Conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58), indicating a prospective study specifically designed to assess the device. The provenance is internal to the controlled study environment.

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

• Benchtop and Biocompatibility Testing: The summary does not specify the use of "experts" to establish a ground truth in the traditional sense (e.g., for image interpretation). Instead, these tests rely on objective, measurable criteria defined by established international standards (e.g., ISO, ASTM). The "ground truth" would be the direct measurement or observation of the device's physical, mechanical, and biological properties against predefined limits or comparison with a predicate.
• Animal Study: The evaluation of the animal study results regarding complications and performance comparability would involve veterinarians and potentially pathologists who are experts in animal physiology and disease interpretation. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set Without Explanation:

• Benchtop and Biocompatibility Testing: An "adjudication method" in the sense of resolving discrepancies between multiple expert interpretations is generally not applicable to the objective measurements performed in these tests. Results are typically pass/fail based on predetermined specifications or direct comparison to controls/predicates.
• Animal Study: While not explicitly stated, observations in animal studies, especially pathological findings, often involve review by multiple experts (e.g., veterinary pathologists). If discrepancies occur, an adjudication process involving consensus or a tie-breaking expert would likely be in place, though this is not detailed in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not Applicable. The ISAAC Neurovascular Navigation Catheter is a physical medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

• Not Applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Benchtop Testing: Objective physical and mechanical measurements, adherence to industry standards, and comparison to predicate device characteristics.
• Biocompatibility Testing: Results obtained from standardized biological assays (e.g., cell cultures, animal models for irritation/sensitization) providing objective data on biological reactions, evaluated against established acceptance criteria (e.g., "non-cytotoxic," "non-irritant").
• Animal Study: Direct observation of device performance (tracking, support) and histological/pathological assessment for complications (e.g., dissection, thrombus, tissue injury) in a living porcine model, compared against the control article.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device, and the concept of a "training set" for an AI algorithm is not relevant here. The device design and manufacturing process would involve extensive engineering development and iterative testing (developmental testing) which is distinct from an AI training set.

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

• Not Applicable. As there is no "training set" in the context of an AI algorithm for this device, a method for establishing its ground truth is not relevant. The device development relies on engineering principles, material science, and performance testing against established standards and predicate device characteristics.

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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 SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries.

The SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal seqment is designed to facilitate vessel selection with 60 cm of distal-shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

The provided document is a 510(k) summary for a medical device (SOFIA 88 Catheter), demonstrating its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on performance (benchtop) and pre-clinical (animal) testing rather than clinical studies with human subjects or AI algorithm performance.

Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample size for test sets (human data), number of experts for ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this specific document as it pertains to a physical medical device (catheter) and not an AI/ML powered device.

However, I can extract the relevant information regarding the performance and equivalency testing conducted for the SOFIA 88 Catheter.

Device: SOFIA 88 Catheter

Type of Device: Percutaneous Catheter (physical medical device)

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

The acceptance criteria are generally implied by the "Pass" result for each test, indicating that the device met the pre-defined standards for each physical and functional characteristic. The document doesn't explicitly state quantitative acceptance limits for each test but rather confirms successful completion.

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

• Benchtop Testing: While specific sample sizes for each benchtop test are not provided in this summary, these tests generally involve a statistically significant number of device units (e.g., n=3, 5, or more depending on the test and standard requirements) to ensure reproducibility and reliability. The provenance is internal laboratory testing by MicroVention, Inc. and its contracted labs.
• Biocompatibility Testing: Sample sizes are mentioned for some tests (e.g., New Zealand White Rabbits for irritation/pyrogenicity, Guinea Pigs for maximization, ND4 mice for systemic toxicity, sheep blood for blood loop assay, three rabbits for hemolysis, human serum/plasma for others). The provenance is laboratory testing conducted according to ISO and USP standards.
• Animal Study: The document refers to "a porcine model" without specifying the exact number of animals. It's an acute animal study. The provenance is internal or contracted laboratory animal testing (conducted in accordance with FDA GLP Regulation 21 CFR Part 58).

All data provenance is internal R&D and pre-clinical testing, not human clinical retrospective or prospective data.

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

This section is not applicable as the ground truth for a physical medical device like a catheter is established through objective physical and chemical measurements (benchtop tests) and observed physiological responses in animal models, not through expert human interpretation of medical images or data requiring "ground truth" establishment in the context of an AI algorithm.

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

This is not applicable as there is no human interpretation or subjective judgment that would require an adjudication method in the context of this device's testing. Measurements are objective and pass/fail criteria are pre-defined.

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 is not applicable. This device is a physical catheter, not an AI application, so no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. This is a physical device, not an AI algorithm.

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

The "ground truth" for this device's performance is established via objective engineering and material science measurements (e.g., dimensions, pressure, force), validated laboratory biological assays (e.g., cytotoxicity, hemolysis), and observed physiological responses and pathological findings in an animal model. It is not derived from expert consensus, pathology, or outcomes data in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML powered device that requires a training set.

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

This is not applicable for the reason stated above.

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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

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The BOBBY Balloon Guide Catheter is intended: For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end. The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the BOBBY Balloon Guide Catheter. It's important to note that this is a medical device (catheter), not an AI/algorithm-based device, so the usual metrics for AI performance (like sensitivity, specificity, MRMC studies, training/test sets for AI) are not applicable here.

The "acceptance criteria" for this device are established through various performance and biocompatibility tests designed to ensure its safety and effectiveness for its intended use. The "study that proves the device meets the acceptance criteria" refers to the results of these performance and biocompatibility tests.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comprehensive table under "Performance Testing Summary" and "Biocompatibility Testing Summary." The "Acceptance Criteria" for each test are implied by the "Reference Standard" and the "Results" section confirming that "All samples met the pre-determined acceptance criteria" or similar statements of compliance.

Key:

• Acceptance Criteria (Implied): Meeting the requirements of the stated reference standard or pre-determined specifications.
• Reported Device Performance: "Pass" indicating that all samples tested met the criteria.

Biocompatibility Tests:

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

The document states "All samples met the pre-determined acceptance criteria" implying multiple samples were tested for each performance test. However, the specific sample sizes for each test are not explicitly provided in this summary.

Data Provenance: The tests are described as in vitro (benchtop testing) and in vitro biocompatibility tests, some conducted in a "cerebral vascular model." It is retrospective in the sense that the results are being reported after the tests were conducted. The country of origin for the data is not specified but would typically be where MicroVention, Inc. conducts its R&D and testing, likely in the USA given their address is Tustin, California.

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

This question is not applicable to this type of device submission. The "ground truth" for this medical device is established by physical and chemical properties and performance characteristics measured against recognized international standards (e.g., ISO, ASTM, USP) and internal specifications, rather than by human expert review of images or data.

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

This question is not applicable as there is no human-in-the-loop assessment requiring adjudication for this device's performance testing. The tests are objective measurements against set standards.

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 question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The BOBBY Balloon Guide Catheter is a physical medical device, not an AI or imaging device, and does not involve human readers interpreting data assisted by AI.

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

This question is not applicable. This is not an algorithm-only or AI device.

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

The "ground truth" for this device's performance and biocompatibility is based on established engineering and material science standards (ISO, ASTM, USP), verified physical/chemical measurements, and the device's ability to consistently meet predefined specifications for functionality and safety in a laboratory setting. For comparison, the predicate device's characteristics also serve as a comparative ground.

8. The sample size for the training set

This question is not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

This question is not applicable, as there is no AI training set.

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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:

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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.

• Visual/Dimensional Inspection
• Electrical Resistance
• Exhaustive Extraction Study
• Simulated Use (Preparation/Flush, Introduction, Tracking, Advancement, Kink Resistance, Flexibility, Catheter Compatibility, Deployment, Retraction, Detachment, Wall Apposition)
• Migration Resistance
• Overall performance
• Radial force
• Attachment strength
• Implant joint Tensile Strength
• Pusher Sleeve Retention
• Particulate
• Nickel Ion Release
• Corrosion
• Magnetic Resonance (MR) Testing
• Radiopacity
• Occlusion Time
• Shelf Life |
  | Safety & Effectiveness (In-vivo) | Device must perform safely and effectively in a living system. | Evaluated in "a number of animal studies including multiple animal species and implantation sites," specifically:
• Porcine large animal study
• Intramuscular implant rabbit study
  Conclusion: "The nonclinical data support the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use." |
  | Sterility | Device must be sterile for use. | Same as predicate: EtO (Ethylene Oxide) sterilization process. "No difference. Identical sterilization process." |
  | Radiopacity | Device must be visible under fluoroscopy. | Platinum marker bands at each end of the plug. "Identical marker bands" to predicate. |
  | Delivery System Compatibility | Device must be deliverable through specified microcatheters. | Designed for delivery through a 0.027" ID microcatheter. This is a design difference from the predicate (0.027" to 0.043" ID) but deemed acceptable due to bench and animal testing. |
  | Detachment Mechanism Reliability | The plug must detach reliably. | Thermoelectric detachment system. This is a design difference from the predicate (Mechanical Detachment) but considered acceptable based on "results of bench testing and physician usability study." |

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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