Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

The HydroPearl TM Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl TM Microspheres are offered in a variety of diameters ranging from 75-1100µm and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre- filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl TM Microspheres are delivered to the treatment site through a delivery catheter.

The provided document describes the acceptance criteria and study for the HydroPearl Microspheres, specifically for the expanded indication of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "IPSS score reduction must be X%"). Instead, it reports the observed clinical outcomes and concludes that these results support safe and effective use. The "acceptance criteria" here are implied through the positive clinical outcomes and the comparison to established understanding of PAE effectiveness.

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

• Sample Size (Test Set): 17 patients
• Data Provenance: Retrospective analysis from a single US center.

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

The document does not specify the number or qualifications of experts for establishing ground truth for the clinical data. The data appears to be derived from standard clinical assessments (IPSS, QoL scores, observation of complications) and procedural records (technical success of embolization), rather than an explicit "ground truth" established by independent expert panel review.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical outcomes in the retrospective study. Clinical outcomes were reported based on collected patient data.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the device's clinical performance in patients, not on comparing AI assistance to human readers.

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

This is not applicable as the HydroPearl Microspheres are a medical device (embolization agent), not an AI algorithm. The study assesses the performance of the physical device when used by clinicians.

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

The "ground truth" for the clinical study's effectiveness was established through patient-reported outcomes data and objective clinical assessments:

• International Prostate Symptom Score (IPSS) and Quality of Life (QoL) scores (patient-reported).
• Observation of BPH medication usage reduction/cessation.
• Objective assessment of technical success (bilateral PAE).
• Adverse event reporting.

8. The sample size for the training set

The document does not describe a "training set" in the context of an AI algorithm. For the clinical performance anaysis, it refers to a retrospective analysis of existing data.

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

Not applicable, as this is not an AI algorithm study requiring a training set with established ground truth in that context.

Ask a specific question about this device

VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.

VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.

The VIA® Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the radiopaque marker bands using fluoroscopic techniques (VIA17 Microcatheter has 2 radiopaque marker bands. VIA 21, 27 and 33 Microcatheters have one radiopaque tip marker band). Diagnostic and interventional devices can be delivered through the lumen of the catheter to the treatment site. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories.

The provided FDA 510(k) summary for the VIA® Microcatheter does not contain the specific information required to answer all parts of your request, as it pertains to a medical device's 510(k) clearance rather than a diagnostic AI algorithm study. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing (biocompatibility and bench testing), not on a clinical effectiveness study with human readers and AI assistance.

Therefore, for aspects related to AI performance, human expert adjudication, effect size with AI assistance, and large-scale training/test sets for an AI algorithm (questions 2-9), the information is not applicable or not provided in this document.

However, I can extract the acceptance criteria and reported performance for the device itself (the VIA® Microcatheter) based on the provided bench testing data.

Acceptance Criteria and Reported Device Performance (Based on Bench Testing)

Note: Some tests (Coating Integrity, Catheter Torque Strength, Flow Rate, Dead Space) were reported "For characterization only," implying they were not subject to specific pass/fail acceptance criteria for this submission but were measured to understand device properties.

Study Details (for the VIA® Microcatheter, not an AI study)

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

   • See table above.

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

   • Sample Size: The document does not specify exact sample sizes for each bench test. For biocompatibility tests, specific numbers of animals (e.g., 17 male Hartley Guinea Pigs, 3 female New Zealand White Rabbits, 20 female Albino Swiss Mice, 2 Canine) are mentioned, but these are for biological testing, not for evaluating an AI algorithm on a medical dataset.
   • Data Provenance: Not applicable for device performance bench testing in the context of AI. The tests are laboratory-based.

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):

   • Not applicable. This is not an AI study requiring expert ground truth for medical images.

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

   • Not applicable. This is not an AI study requiring expert adjudication.

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 done. This document outlines the premarket notification for a physical medical catheter, not an AI-powered diagnostic tool.

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

   • Not applicable. This is not an AI algorithm.

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

   • For biocompatibility testing, the "ground truth" is defined by biological responses in test organisms and in vitro systems, evaluated against established ISO standards and criteria for non-toxicity, non-sensitization, non-irritation, non-hemolysis, etc.
   • For bench testing, the "ground truth" is adherence to predefined engineering and functional specifications or standards (e.g., ISO 10555-1:2014, ISO80369-7:2016).

8. The sample size for the training set:

   • Not applicable. There is no training set for an AI algorithm in this document specific to the device's performance evaluation.

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

   • Not applicable. There is no AI training set.

Ask a specific question about this device

The PG Pro microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

The PG Pro Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the catheter hub is used for the attachment of accessories.

The provided text is for a 510(k) premarket notification for the "PG Pro Microcatheter". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria for an AI/ML type of medical device through a clinical study.

Therefore, the text does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size and data provenance for a test set.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

Instead, the document describes:

• Device Description: The PG Pro Microcatheter is a single lumen catheter designed for introducing over a guidewire to access small, tortuous vasculature for infusing diagnostic and therapeutic agents in the peripheral vasculature.
• Predicate Device: Headway 27 Microcatheter (K142449). A reference device (Headway 17 Microcatheter, K101542) is also listed.
• Comparisons: The document includes a detailed "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" (Table 1) comparing the PG Pro Microcatheter to its predicate and reference devices across properties like Indications For Use, Principle of Operation, Material(s), Proximal ID/OD, Distal ID/OD, Number of Marker bands, Coating, Effective Length, Tip Configuration, Guidewire Compatibility, Method of Supply, and Accessories. The table highlights differences such as the PG Pro being intended only for peripheral vasculature, using a Tungsten coil vs. stainless steel, having a different range of effective lengths, being straight configuration only, being compatible with larger guidewires, and not including a shaping mandrel.
• Performance Data (Non-Clinical):
  • Biocompatibility testing: Conducted according to ISO10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility, as it is considered a limited (<24 hour) circulating blood contacting device.
  • Bench testing: A comprehensive list of tests was performed, including surface contamination, physical attributes, force at break, leakage (liquid, air), static and dynamic burst, durability and lubricity of hydrophilic coating, simulated use in flow model, catheter flow rate, kink resistance, stiffness, flexural fatigue, particulate testing, catheter dead space, torque strength, hub testing, corrosion testing, and radio detectability.
  • Animal Study: An acute large animal study was conducted with n=3 animals. The study assessed the device's safety profile, compatibility with therapeutic agents, and tissue response, concluding that the PG Pro Microcatheter performed similarly to the predicate device (Headway 27 Microcatheter).
• Conclusion: The PG Pro Microcatheter is considered substantially equivalent to the identified predicate based on performance, intended use, design, materials, principle of operation, and overall technological characteristics. The nonclinical data, verification, and validation testing support this conclusion and demonstrate the device should perform as intended.

In summary, this document is a 510(k) submission for a physical medical device (microcatheter) and relies on benchmarking against a predicate device, along with non-clinical (bench and animal) testing to demonstrate substantial equivalence, not the evaluation of an AI algorithm against specific performance criteria.

Ask a specific question about this device

The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.

The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.

The provided text describes a 510(k) premarket notification for a medical device, the SOFIA Plus Aspiration Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided does not align with the typical structure of an AI/ML medical device study demonstrating algorithmic performance against acceptance criteria.

The document primarily details the pre-clinical testing on the device itself and an animal study to evaluate its aspiration performance and safety. It does not describe an AI/ML algorithm or a study of its performance.

However, I can extract and structure the information about the acceptance criteria and performance of the physical device based on the provided text, while acknowledging that this is not an AI/ML study.

Here's an interpretation of the request using the available information:

The SOFIA Plus Aspiration Catheter underwent extensive pre-clinical testing to demonstrate its performance and substantial equivalence to a predicate device. The acceptance criteria for these tests were typically defined by established specifications, industry standards (e.g., ISO), or direct comparison to the predicate device.

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 numerical sample size for each bench test. Instead, it refers to "test articles" and general results (e.g., "Test articles achieved a rating...") and in some cases, "two out of two test sites" for the animal study.

• Test Set Provenance: The tests are pre-clinical bench tests performed by the manufacturer (MicroVention, Inc., Tustin, California, USA) and an animal study (swine model). The information does not specify the country of origin of data in terms of retrospective/prospective human patient data, as this is not a human clinical trial. All tests would have been performed prospectively as part of the device development and submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the document describes pre-clinical physical device testing and an animal study, not an AI/ML algorithm study that requires expert adjudication of image-based ground truth. For the simulated-use tests, the performance ratings (e.g., $\geq3$) would be based on qualitative assessment by trained personnel, but they are not referred to as "experts" in the context of clinical ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML algorithm study involving interpretation of clinical data by multiple readers, there is no need for an adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this was not done. This document pertains to the 510(k) clearance of a physical medical device. MRMC studies are typically performed for AI-driven diagnostic or assistive technologies to assess their impact on human reader performance.

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

No, this was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Specifications and Standards: For dimensional, mechanical, and safety properties (e.g., ISO standards, specified psi limits, force at break criteria).
• Comparative Performance to Predicate Devices: Performance attributes (e.g., stiffness, vacuum pressure, torque response) were compared to the legally marketed predicate device (Penumbra Reperfusion Catheter ACE64 and ACE68).
• Animal Study Observations: For aspiration performance and histopathological evaluations in a swine model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study, therefore there is no training set for an algorithm.

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

Not applicable. As there is no AI/ML algorithm training set.

Ask a specific question about this device