Search Results

The Aventus Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for the minimally invasive removal of emboli and thrombi from blood vessels, infusing fluids, and is intended to be used in the peripheral vasculature and for the treatment of pulmonary embolism. The System is comprised of the following major components:

• Aventus Thrombectomy Catheter
• Clot Management System consisting of:
  • Aspiration Syringe
  • Clot Canister

The System is compatible with a standard 24-French (24F) introducer sheath, 4F Navigation Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.

The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

The provided text describes the regulatory clearance of a medical device, the Aventus Thrombectomy System, and outlines the performance data submitted to support its substantial equivalence. However, the document does NOT contain information about an AI/Software component that would require "acceptance criteria" based on metrics like sensitivity, specificity, accuracy, or an MRMC study.

The software testing mentioned refers to:

• "Software documentation was leveraged from the reference device as recommended by FDA Guidance: Content of Premarket Submissions for Device Software Functions, issued June 14, 2023." This indicates that the software functions are likely related to guiding the device's operation, sensing, or control rather than an AI-driven diagnostic or interpretative function. There is no mention of AI, machine learning, or algorithms for image analysis or diagnostic support.

Therefore, I cannot provide the requested information about acceptance criteria, test set details (sample size, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details because the provided document does not indicate the presence of such an AI/ML component.

The performance data listed pertains to the physical device itself (biocompatibility, sterilization, packaging, electrical safety, bench testing, animal studies, and a clinical trial on the device's safety and effectiveness in treating pulmonary embolism).

If the device did indeed have an AI/ML component, the type of information you requested (acceptance criteria, ground truth establishment, MRMC study, etc.) would be critical for its regulatory clearance. Based on the provided text, the Aventus Thrombectomy System appears to be a mechanical thrombectomy device with some electronic/software components for its control and sensing, but not for AI-assisted image analysis or diagnostic capabilities.

Ask a specific question about this device

The Aventus Thrombectomy System is indicated for:
• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:

• Aventus Thrombectomy Catheter .
• Clot Management System consisting of:
• . Aspiration Syringe
• . Clot Canister
  The System is compatible with standard introducer sheaths (24F or 16F). 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model), and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
  The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics.
  The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.
  The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

This document is a 510(k) Premarket Notification from the FDA regarding the Aventus Thrombectomy System. It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the provided text does not contain any information about an AI/software component that would require a study proving the device meets acceptance criteria related to AI performance, or any details about a clinical study involving human readers or ground truth establishment. The mentions of "software" and "refine the algorithm" are general and don't provide specifics on AI acceptance criteria or performance studies.

Therefore, I cannot fulfill your request for detailed information about acceptance criteria for an AI component, sample sizes for test sets, expert involvement in ground truth, MRMC studies, standalone performance, or training set details. This document primarily focuses on the physical device (catheter-based thrombectomy system) and its equivalence to a prior version, primarily through bench, biocompatibility, sterilization, packaging, and electrical safety testing.

The relevant information regarding software is:

• Software Testing: "Software documentation and testing was updated from the predicate device as recommended by FDA Guidance: Content of Premarket Submissions for Device Software Functions, issued June 14, 2023."
• Device Modification: "Update of the device software to refine the algorithm and account for the reduction in diameter."

These statements indicate that software was updated and tested according to FDA guidance, but they do not provide specific performance metrics, acceptance criteria for an AI algorithm (e.g., sensitivity, specificity, AUC), or details of a study setup that would validate such metrics. The "algorithm" mentioned likely refers to control or sensing algorithms for the catheter, not a diagnostic or prognostic AI.

In summary, the provided document does not contain the information needed to address your questions regarding AI acceptance criteria and study details.

Ask a specific question about this device

The Aventus Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Iniection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

The Aventus Thrombectomy System is a catheter-based manual aspiration svstem designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:

• Aventus Thrombectomy Catheter
• Clot Management System consisting of:
  • Aspiration Syringe
  • Clot Canister
    The System is compatible with a standard 24-French (24F) introducer sheath, 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model) and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
    The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics.
    The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.
    The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

The provided document is a 510(k) summary for the Aventus Thrombectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details on a de novo clinical study with specific acceptance criteria and detailed performance of an AI algorithm.

Therefore, the requested information regarding acceptance criteria, specific device performance metrics in a clinical context (like sensitivity, specificity, accuracy), sample sizes for test sets, expert qualifications, and ground truth establishment, is not present in this document. The document primarily addresses engineering and safety performance data, often leveraged from the predicate device, to support the claim of substantial equivalence.

Here's an analysis based on the information available in the document:

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

The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, or success rates for thrombus removal in a clinical setting) or reported device performance against such metrics. Instead, it lists various engineering and safety performance tests and states that the "physical and functional requirements were met" and that the device "demonstrated that the System was able to be used safely ... and met all pre-defined study endpoints" in an animal study.

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: Not specified for any clinical or human-use test set. The animal study mentions a "chronic large animal GLP study," but an N is not given.
• Data Provenance: Not specified for any clinical or human-use data. The animal study was conducted in compliance with GLP regulation (21 CFR Part 58), which implies a controlled, prospective study design, but the location is not mentioned.

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 information is not available in the document. The submission focuses on substantial equivalence based on material, engineering, and safety testing, not on a clinical performance study requiring expert ground truth establishment for diagnostic or treatment effectiveness.

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

This information is not available in the document, as there is no described clinical test set requiring expert adjudication for ground truth.

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

There is no mention of an MRMC study or AI assistance in this document. The device is a physical thrombectomy system, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is not an AI algorithm. It's a medical device system.

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

For the safety and performance tests described:

• Biocompatibility: Ground truth is established by standardized testing protocols (ISO 10993-1:2018) and the observation of biological responses to the materials.
• Sterilization: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) and meeting pyrogen limits.
• Bench Performance: Ground truth is against predefined engineering specifications and physical properties (e.g., tensile strength values, leak rates, clot removal efficiency in a model).
• Non-Clinical (GLP Animal Testing): Ground truth is established by pre-defined study endpoints focusing on safety and functional performance in an animal model, observed by veterinary and research staff.
  Ultimately, the ground truth for this submission is that the device is substantially equivalent to its predicate based on the provided engineering, safety, and non-clinical data.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm.

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

This information is not applicable as the device is not an AI algorithm.

Ask a specific question about this device

The Aventus Thrombectomy System is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:

• Aventus Aspiration Catheter II .
• . Clot Management System consisting of:
  • . Aspiration Syringe
  • . Clot Canister

The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.

The Aventus Aspiration Catheter II includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. A dedicated navigation catheter lumen for use with an off-the-shelf 4F Navigation Catheter, and dedicated infusion lumen for injection of fluids is also included in the shaft. The Catheter Handle assists the clinician in navigating within the vasculature and also includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

This document is a 510(k) summary for the Inquis Medical Aventus Thrombectomy System (IM-2001/IM-0002). It describes the device, its intended use, and the performance data provided to demonstrate substantial equivalence to a predicate device.

Based on the provided text, the device in question is a medical device (Aventus Thrombectomy System), not an AI/software device. Therefore, the questions regarding acceptance criteria for AI/software, MRMC studies, standalone performance, ground truth for training/test sets, and sample sizes for training/test sets related to AI/software are not applicable.

The performance data section (VII. PERFORMANCE DATA) describes various tests conducted to support the substantial equivalence claim. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance: This document does not present a formal table of "acceptance criteria" for the device's performance in the way one might expect for a software or AI model's accuracy. Instead, it lists various performance tests and states that the device "successfully met" or "complied with requirements" or "demonstrated that the physical and functional requirements were met."

   Performance Testing	Reported Device Performance and "Acceptance"
   Biocompatibility Testing	"...do not pose a risk of negative interaction with patients." (Leveraged from predicate)
   Sterilization	"demonstrated an SAL of 10-6." and "meets established pyrogen limit specifications." (Leveraged from predicate)
   Distribution, Packaging & Shelf-Life	"successfully tested demonstrating integrity of the sterile barrier and preservation of the System's properties." (Accelerated aging for 6-month shelf life leveraged from predicate)
   Software Testing	"successful software verification and validation testing, was provided as recommended by FDA Guidance..."
   Electrical Safety / EMC Testing	"complies with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 and IEC 62366-1."
   Performance Testing - Bench	"demonstrated that the physical and functional requirements were met." This includes: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Compatibility Testing, Torque Transmission Testing, Kink Testing, Simulated-Use Verification and Validation of Sensing. (Kink and Torque to Failure leveraged from predicate).
   Performance Testing - Non-Clinical	"demonstrated that the System was able to be used safely in a chronic large animal GLP study and met all pre-defined study endpoints." (Leveraged from predicate)

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

   • The document does not specify exact sample sizes for each bench test (e.g., number of catheters tested for tensile strength).
   • For the non-clinical (animal) study, it mentions "a chronic large animal GLP study." It does not specify the number of animals or data provenance (country of origin), nor whether it was retrospective or prospective, though GLP (Good Laboratory Practice) studies are typically prospective.

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 as the document describes performance testing of a physical medical device, not a diagnostic AI system requiring expert-established ground truth.

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

   • Not applicable for the type of device and testing described.

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 AI-assisted diagnostic device.

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

   • Not applicable. The device includes "disposable powered electronics and embedded software" for sensing (as stated in Section IV and VII), and "Software documentation, including successful software verification and validation testing, was provided." However, the description refers to V&V for the software functions of the device, not a standalone AI diagnostic algorithm.

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

   • For the physical and functional performance tests (bench testing), the "ground truth" would be established engineering specifications and physical measurements, rather than clinical consensus or pathology.
   • For the non-clinical animal study, the "ground truth" would be observed safety and performance metrics in the animal model, as defined by the study protocol and endpoints.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in the typical sense. The software mentioned is "embedded software" likely controlling device functions, not a learning algorithm trained on data.

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

   • Not applicable.

Ask a specific question about this device

The Aventus Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:

• Aspiration Catheter
• Clot Management System consisting of:
  • Aspiration Syringe
  • Clot Canister
    The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
    The Aspiration Catheter includes an atraumatic radiopaque Distal Tip with angled aspiration orifice for directional aspiration and navigation without a dilator, a dedicated navigation catheter lumen with integrated Navigation Catheter, a dedicated infusion lumen for injection of fluids, and a Handle designed to navigate within the vasculature. The Aspiration Catheter shaft incorporates a metallic reinforcement made of stainless steel, an inner liner and polymeric jacket material with variable stiffness.
    The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

The provided text describes a 510(k) premarket notification for the Aventus Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a clinical or AI performance context.

The document does not contain information related to AI/software performance, human reader studies, or explicit acceptance criteria for such an AI system. It primarily details the physical and functional characteristics of a medical device (a thrombectomy catheter) and its non-clinical performance testing (biocompatibility, sterilization, bench testing, and animal studies).

Therefore, I cannot provide the requested information, which pertains to the performance validation of an AI/software device. The provided text describes the regulatory filing for a physical medical device, not an AI or software product.

Based on the provided text, the device is a physical medical device (Aventus Thrombectomy System), not an AI/software product. Therefore, the requested information (AI acceptance criteria, human reader studies, ground truth establishment for AI, etc.) is not present in the document.

The document details the following performance data, which are typical for physical medical devices seeking 510(k) clearance:

• Biocompatibility Testing: Successful completion per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility). This demonstrated no risk of negative interaction with patients.
• Sterilization Testing: Successful completion per ISO 14937:2009, with a demonstrated SAL of 10^-6. Bacterial endotoxins test (BET) also confirmed meeting pyrogen limit specifications.
• Distribution, Packaging and Shelf-Life Testing: Successful completion of distribution testing and accelerated aging simulating a six-month shelf-life, demonstrating integrity of the sterile barrier and preservation of properties.
• Performance Testing - Bench: Design verification testing demonstrated physical and functional requirements were met. Specific tests included: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Pouch Seal Visual Inspection and Bubble Test, Pouch Seal Strength, Compatibility Testing, Torque Transmission Testing, Kink Testing, Kink and Torque to Failure, Simulated-Use.
• Performance Testing – Non-Clinical (GLP Animal Study): A GLP animal study demonstrated the system could be used safely in a chronic large animal study and met all pre-defined study endpoints.

The document does not describe any acceptance criteria or studies related to AI/software performance, such as sensitivity, specificity, human reader performance, or ground truth derived from expert consensus/pathology. Thus, I cannot populate the table or answer the specific questions about AI/software validation.

Ask a specific question about this device