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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.

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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.

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The Talon Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation/puncture.

The Talon Transseptal Sheath (“Sheath”) provides a conduit for catheterization and angiography of specific heart chambers and locations. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. The Sheath is packaged with a dilator and two 60 cc syringes. The dilator is compatible with a 0.035" guidewire and has a tapered tip which aids insertion and positioning of the Sheath. The dilator attaches to the Sheath hemostasis valve, and a Y-connector with hemostasis valve connects to the dilator luer connector. A quick-release syringe is provided to connect to the Sheath sideport, and a standard VacLok syringe is provided to connect to the Sheath flush port and dilator connector.

The provided text describes the regulatory clearance for the Talon Transseptal Sheath. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the context of an AI/human reader study.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set details) are not applicable or not provided in this document, as they relate to the evaluation of AI-driven diagnostic devices, which the Talon Transseptal Sheath is not.

Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing section, which serves as the "study" for this device's regulatory submission:

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

The document states that "Test results demonstrated that all acceptance criteria were met," but it does not provide specific numerical acceptance criteria or reported device performance metrics for each test. It simply lists the types of tests performed.

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not applicable in the context of device performance testing. These are laboratory/bench tests, not studies involving human data.

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

• Not Applicable. This device is not an AI diagnostic device that relies on expert interpretation to establish ground truth for a test set. Its performance is evaluated through engineering and biological testing.

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

• Not Applicable. See explanation above.

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. An MRMC study was not done as this is a medical device (transseptal sheath), not an AI-driven diagnostic or imaging aid.

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

• Not Applicable. This is not an algorithm or AI device. Its "standalone" performance is measured by its physical and biological properties.

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

• For Biocompatibility: Standards (ISO 10993-1) and validated laboratory test methodologies.
• For Sterilization: Standards (ISO 11135:2014/Amd 1:2018, AAMI TIR 28:2016) and validated sterilization processes.
• For Performance Tests: Established product specifications, engineering standards, and functional requirements, identified through a Design Failure Modes and Effects Analysis. The "ground truth" is adherence to these predefined criteria.

8. The sample size for the training set

• Not Applicable. This device does not use a training set as it is not an AI/machine learning product.

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

• Not Applicable. See explanation above.

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The Excipio LV Thrombectomy Device indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels.

The Excipio LV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device. The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (10-25mm in diameter). The thickness of the basket wires enhance the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

The provided text describes the Excipio LV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance. The document is a 510(k) summary for a medical device which focuses on non-clinical testing for safety and performance compared to existing devices.

Therefore, most of the requested information regarding AI/algorithm performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The in vitro bench tests demonstrated that the Excipio LV Thrombectomy Device met all acceptance criteria and performed similarly to the predicate device." and "Performance data demonstrate that the device functions as intended and has a performance profile that is similar to the predicate devices."

The acceptance criteria themselves are not explicitly detailed as numerical values or specific thresholds in this document. Instead, they are implied to be met by the successful execution and results of the listed non-clinical tests.

Regarding the AI-specific questions:

2. Sample size used for the test set and the data provenance: Not applicable; this document does not describe a study involving a test set for AI/algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For the animal study, the ground truth was established by physician venographic assessment and histopathology. For the bench tests, the ground truth was based on engineering and material science standards/measurements.
8. The sample size for the training set: Not applicable; this document does not describe a training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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