Search Results

The ClotTriever Thrombectomy System is indicated for:

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

The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).

N/A

Ask a specific question about this device

The Vesalio Peripheral Catheter is intended for use in the peripheral arterial vasculature for:

• the removal of fresh, soft emboli and thrombi
• infusion of diagnostic agents, such as contrast media

The Vesalio Peripheral System consists of 1) Peripheral Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set.

The Peripheral Catheter is a single-lumen, coil-reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the peripheral arterial vasculature when connected to a compatible aspiration pump and the Aspiration Tubing Set.

The catheter is a hollow cylindrical tube constructed using a combination of medical-grade polymers with metal reinforcement, a lubricous inner liner made from PTFE and the outer jacket consisting of thermoplastics made of polyurethane, polyether block amide, and nylon 12. The distal end of the catheter has a hydrophilic coating aimed to reduce friction and aid tracking through the vasculature. The catheter employs radiopaque characteristics for angiographic visualization.

On the proximal end, the catheter incorporates a flexible strain relief, which provides kink resistance, and a translucent, polycarbonate female luer hub to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter.

A peel-away introducer sheath is provided in the package to facilitate the insertion of the Peripheral Catheter's distal tip into an appropriate vascular sheath.

The Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to an RHV or the female luer hub of the catheter. The other end of the tubing consists of a hose fitting to enable connection with a vacuum pump. A flow switch is connected in line to provide vacuum control. The Peripheral System is provided sterile, non-pyrogenic, and is intended for single use only.

N/A

Ask a specific question about this device

The Recana Thrombectomy Catheter System is indicated for:

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

The Recana Thrombectomy Catheter System is indicated for use in peripheral venous vasculature.

The Recana Thrombectomy Catheter System is designed to remove thrombus and emboli from native vessels or stented veins. The system is comprised of the debulking catheter, collection basket(s) with delivery sheaths, and a family of sheaths. Together, the Recana Thrombectomy Catheter System functions to capture and remove obstructive / occlusive thrombus from the venous vasculature.

The debulking catheter utilizes an adjustable diameter stainless steel coring element to remove thrombus from the venous vasculature. Handle controls enable expansion and collapse of the coring element to achieve the desired working diameter. The debulking catheter is 0.035" guidewire and 0.060" basket shaft compatible and provides a working length of 80cm.

18mm and 30mm Collection basket(s) are self-expanding nitinol wire-form and braided structures designed to ensure capture and removal of thrombi and emboli. The basket shaft has a 0.035" guidewire compatible lumen for over the wire delivery through a 9Fr Delivery Sheath with a working length of 95cm.

Sheaths for introduction of the debulking catheter and collection baskets into the vasculature and for the recapture and removal of thrombi and emboli via the collection basket(s) are offered in four (4) size configurations (13Fr x 30cm, 13Fr x 90cm, 16Fr x 30cm, and 16Fr x 90cm) providing optionality based on access vessel size and location.

N/A

Ask a specific question about this device

INDIGO Aspiration Catheters and Separators

As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

INDIGO Aspiration Tubing

As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump

The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of several devices:

• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing
• INDIGO Separator

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister.

Lightning Flash and Lightning Bolt Aspiration Tubing:

The Lightning Flash and Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating the transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.

N/A

Ask a specific question about this device

The Symphony Thrombectomy System is intended for:

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

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

The Symphony 16F 82cm Thrombectomy System is intended for:

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

The Symphony 16F 82cm Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

The Symphony™ Thrombectomy System is comprised of the following devices:

• 24F Symphony Catheter
• 24F Symphony Standard Dilator
• 24F Symphony Advance™ Long Dilator
• 24F Symphony ProHelix™
• 16F Symphony Catheter
• 16F Symphony Dilator
• 16F Symphony ProHelix™
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

The Symphony™ 16F 82cm Thrombectomy System is comprised of the following devices:

• 16F 82cm Symphony Catheter
• 16F 82cm Symphony Length Matched Dilator
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

Both Systems are designed to remove thrombus/embolus (also referred to as 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheters and the Symphony 16F 82cm Catheter target aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter.

The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus in the peripheral vasculature or pulmonary anatomy. The 16F 82cm Catheter and compatible Dilator are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of thrombus in the peripheral vasculature. The Symphony 16F 82cm Catheter and compatible Dilator are not intended for use in the pulmonary anatomy. Both the Symphony Catheters and the Symphony 16F 82cm Catheter are used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.

As needed, the Symphony ProHelix may be introduced through a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.

Here's a breakdown of the acceptance criteria and study details for the Imperative Care, Inc. Symphony™ Thrombectomy System, specifically for the expanded pulmonary embolism indication, based on the provided 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Study (SYMPHONY-PE):

  • ITT Cohort (Safety Analysis): 109 subjects
  • mITT Cohort (Efficacy Analysis - device only used, no thrombolytics/other devices within 48h): 106 subjects
  • Primary Efficacy Analysis Population (mITT with paired RV/LV measurements): 102 subjects

• Data Provenance: The SYMPHONY-PE clinical study was a prospective, multicenter, single-arm, open label study conducted across 19 sites in the U.S.

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

• Ground Truth for Clinical Endpoints:
  • Primary Efficacy Endpoints (RV/LV measurements): Adjudicated by an independent imaging core lab. The specific number and qualifications of experts within this core lab are not detailed in the provided document.
  • Primary Safety Endpoints (Major Adverse Events): Adjudicated by an Independent Safety Board (ISB). The specific number and qualifications of experts on this board are not detailed in the provided document.
  • Clinical Events Committee (CEC): Also reviewed safety endpoints data. The number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• The document states that the primary efficacy endpoint (mean reduction in RV/LV) was "independent core-lab adjudicated."
• The primary safety endpoint (MAE rate) was "adjudicated by the Independent Safety Board (ISB)."
• No specific method like "2+1" or "3+1" concensus is described for the adjudication processes. It implies that the core lab and ISB performed their respective adjudications, likely following their own established protocols.

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

• No, an MRMC comparative effectiveness study was not done. The SYMPHONY-PE study was a single-arm study evaluating the safety and effectiveness of the device itself against pre-specified performance goals, not comparing its performance or human reader performance with and without AI assistance, or against another device.
• Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported, as AI is not explicitly mentioned as part of the system or as an aid to human readers in this context.

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. The Symphony™ Thrombectomy System is a medical device for mechanical thrombectomy, not an AI or software algorithm that provides a diagnostic output in a standalone manner. The clinical study evaluated the device in vivo during actual procedures.

7. The Type of Ground Truth Used

• Clinical Outcomes Data: For the SYMPHONY-PE clinical study, the ground truth was based on clinical outcomes measured in human subjects.
  • Efficacy: Reduction in RV/LV ratio, assessed by CT Angiography (CTA) and adjudicated by an independent imaging core lab. This is a quantitative, image-based clinical measurement.
  • Safety: Rates of Major Adverse Events (MAE) including bleeding, mortality, and device-related SAEs, adjudicated by an Independent Safety Board and CEC. This is based on clinical observations and event reporting.

8. The Sample Size for the Training Set

• Not applicable / Not provided. The Symphony™ Thrombectomy System is a mechanical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.
• The document does describe extensive in-vitro bench testing and in-vivo GLP pre-clinical animal testing to validate the device's performance prior to human clinical trials.

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

• Not applicable / Not provided. As mentioned above, there is no "training set" for this mechanical device. The ground truth for its development and verification was established through various engineering tests and animal studies, which are designed to validate physical performance, material properties, and biocompatibility against established standards and safety profiles.

Ask a specific question about this device

The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

• FLOWRUNNER Aspiration Catheter
• FLOWRUNNER Aspiration Sheath
• Vacuum Fitting
• High Flow Stopcock Connector
• Y-Connector with Hemostatic Valve
• Hand Actuator Clip

The FLOWRUNNER Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. The system has demonstrated compatibility with standard vascular implants, including stents and filters. It is a single use, over-the-wire, catheter-based system with the ability to infuse fluid. The FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The FLOWRUNNER Aspiration System is introduced to the site of the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

The FLOWRUNNER Aspiration System comes in 12F, 14F compatible diameters and 60cm, 80cm, 100cm and 120cm lengths.

The provided FDA 510(k) clearance letter and summary for the FLOWRUNNER Aspiration System are for a medical device (an embolectomy catheter), not an AI/ML powered device. As such, the document does not contain information typically found in submissions for AI/ML devices regarding acceptance criteria, study design for AI performance, ground truth, or expert involvement in classification.

The information provided focuses on the FLOWRUNNER Aspiration System's equivalence to a predicate device (ICE Aspiration System) for its intended use in removing emboli and thrombi from peripheral vessels. The "performance data" section refers to bench testing, which is standard for hardware medical devices, not AI/ML performance metrics.

Therefore, I cannot extract the requested information about acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth establishment, or training set size. This document does not describe a study involving AI/ML.

Here's a summary of what information can be extracted from the document, related to its non-AI performance claims:

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

The document summarizes the performance testing generically as "Bench testing was performed to support a determination of substantial equivalence to the predicate." It lists the types of bench tests conducted but does not provide specific acceptance criteria values or detailed reported performance results against those criteria.

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

Not applicable, as this refers to bench testing on physical components, not a clinical test set with patient data.

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

Not applicable. Ground truth for clinical data is irrelevant to bench testing of a hardware device.

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:

No. This device is not AI-powered, so no such study was conducted or is relevant.

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

No. This device is not an algorithm. Bench testing evaluates the physical device's performance.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For the bench testing, the "ground truth" would be engineering specifications and validated test methods to assess the physical device's capabilities (e.g., ability to capture thrombus in a model, compatibility with stents).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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 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 Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.

The Excipio LV Prime 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 (6-16 mm in diameter). The thickness of the basket wires enhances the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

Let's break down the information regarding the acceptance criteria and study for the Excipio LV Prime Thrombectomy Device, based on the provided FDA 510(k) clearance letter.

It's important to note that this document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described here is primarily a non-clinical bench testing campaign aimed at proving the new device performs similarly and meets a defined set of engineering and performance specifications. There is no clinical study involving human (or animal) subjects described in this document for the Excipio LV Prime Thrombectomy Device. Thus, concepts like "human readers," "AI assistance," "effect size," or "ground truth for training/test set" in the context of clinical outcomes or diagnostic accuracy are not applicable to this type of device and submission.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical laboratory testing performed to support the substantial equivalence. The acceptance criteria for these tests are implicitly that the device met the criteria and functioned as intended, with a performance profile similar to predicate devices. Specific quantitative acceptance criteria or detailed reported performance values are not explicitly stated in this summary. Instead, it broadly states that the device "met all acceptance criteria" and "functioned as intended."

Table of Acceptance Criteria and Reported Device Performance:

Study Details: Non-Clinical Bench Testing

Since this is a thrombectomy device and the submission is for 510(k) clearance based on substantial equivalence, the "study" referred to is a series of in vitro bench tests.

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

   • The document does not explicitly state the specific number of units tested for each non-clinical test (e.g., how many devices were subjected to kink resistance or tensile testing). This level of detail is typically found in the full 510(k) submission, not the summary.
   • Data Provenance: All data is from in vitro bench testing conducted by the manufacturer, Contego Medical, Inc. The country of origin for this testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contracted testing lab. This is by definition retrospective in the sense that the testing is performed before submission for clearance.

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

   • Not Applicable. For non-clinical bench testing of a medical device, "ground truth" is established by engineering specifications, validated test methods, and industry standards (e.g., ISO standards). There are no "experts" establishing a clinical judgment ground truth in this context. The "experts" involved would be the design engineers, quality engineers, and test technicians who define the test protocols and interpret the results against the defined acceptance criteria.

3. Adjudication Method for the Test Set:

   • None Applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where multiple human readers' opinions need to be reconciled to establish a ground truth. For bench testing, results are typically objective measurements compared directly against predetermined pass/fail criteria.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, not done. An MRMC study is relevant to diagnostic imaging devices or other technologies where human interpretation is involved. This device is a mechanical thrombectomy device; its performance is evaluated by its physical characteristics and efficacy in removing thrombus in a lab setting, not by aiding human readers in diagnosis.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

   • Not Applicable. This device is an invasive medical device, not a software algorithm. Its use inherently involves a human operator (a clinician) and is not "standalone" in the sense of an unassisted algorithm making decisions.

6. Type of Ground Truth Used:

   • For the non-clinical testing, the "ground truth" is defined by:
     • Engineering specifications and design requirements: For dimensional, kink resistance, torsional strength, tensile, radial force, and corrosion testing.
     • Validated test methods and industry standards (e.g., ISO 10993-1): For biocompatibility, simulated use, and clot removal testing.
     • Manufacturer's internal quality standards.

7. Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a physical, mechanical medical device, not an AI/ML system.

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

   • Not Applicable. As above, there is no training set for this type of device.

Ask a specific question about this device

The Liberant Thrombectomy System is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems.

The Liberant Thrombectomy System consists of the Liberant Thrombectomy Set (catheter, clotbuster, dilator, aspiration tubing and hemostasis valve), Liberant Blood Conservation Unit (BCU), Riptide Aspiration Pump and Riptide Collection Canister with intermediate tubing. The Liberant Thrombectomy Set is single use and provided sterile.

The Liberant BCU and Riptide Pump are provided separately from the Liberant Thrombectomy Set as non-sterile capital units. The single use, non-sterile Riptide Collection Canister is provided separately to the pump.

The provided FDA 510(k) clearance letter pertains to a thrombectomy system, which is a physical medical device (catheter-based system) used for removing blood clots. It is not an AI/ML device. Therefore, the request for acceptance criteria and study details relevant to AI/ML devices, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance, cannot be answered from the provided text.

The document focuses on the substantial equivalence of the Liberant Thrombectomy System to a predicate device (Penumbra Indigo Aspiration System) based on:

• Indications for Use: Both systems are indicated for the removal of fresh, soft emboli or thrombi from peripheral arterial and venous systems.
• Operating Principle/Technological Design: Both utilize continuous aspiration and fragmentation tools (clotbuster/separator).
• Catheter Specifications: Similar sizes, lengths, and guidewire compatibility.
• Non-Clinical Data: Extensive performance, biocompatibility, shelf-life, sterilization, packaging, software validation (for the pump control), and electrical/EMC testing were performed. This type of "software validation" typically refers to embedded software controlling the pump mechanics, not an AI/ML diagnostic or predictive algorithm.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and study details because the provided document describes a non-AI medical device.

Ask a specific question about this device

The Symphony Thrombectomy System is intended for:

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

The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

The Symphony 16F 82cm Thrombectomy System is intended for:

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

The Symphony 16F 82cm Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

The Symphony™ Thrombectomy System is comprised of several devices:

• 24F Symphony Catheter
• 24F Symphony Standard Dilator
• 24F Symphony Advance™ Long Dilator
• 24F Symphony ProHelix™
• 16F Symphony Catheter
• 16F Symphony Dilator
• 16F Symphony ProHelix™
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

The Symphony™ 16F 82cm Thrombectomy System is comprised of several devices:

• 16F 82cm Symphony Catheter
• 16F 82cm Symphony Length Matched Dilator
• Symphony Clot Container
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

Both Systems are designed to remove thrombus/embolus (also referred to as 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter.

The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus. The Symphony Catheter is used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.
As needed, the Symphony ProHelix may be introduced through a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.

The provided 510(k) clearance letter details the substantial equivalence of the Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System to a predicate device. However, the document does not describe a study involving "acceptance criteria" and "reported device performance" in the context of an AI/human reader study or a standalone algorithm study looking at diagnostic performance metrics.

Instead, the document focuses on the technical and physical performance characteristics of a medical device (a thrombectomy system) designed for the non-surgical removal of emboli and thrombi. The "acceptance criteria" mentioned in the document refer to engineering and material performance specifications rather than diagnostic accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes assessed through a study with a test set of data (e.g., sensitivity, specificity, accuracy for an AI system). The "acceptance criteria" listed are for bench and laboratory tests (e.g., Kink/Bend Verification, Tensile and Torque Strength Verification).
2. Sample size used for the test set and data provenance: There is no mention of a "test set" in the context of diagnostic data. The "testing" refers to physical device performance.
3. Number of experts used to establish ground truth and their qualifications: Ground truth in this context would typically refer to a diagnosis or an outcome for a dataset. The document refers to engineering verification of device function.
4. Adjudication method for the test set: Not applicable based on the content.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The approval is for a physical medical device, not a diagnostic AI tool.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the diagnostic sense. The "ground truth" for these tests are engineering specifications.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
9. How ground truth for the training set was established: Not applicable.

Summary of "Acceptance Criteria" and "Study" as described in the provided 510(k) (focused on device function, not diagnostic performance):

The "studies" conducted were a series of bench and laboratory (in-vitro) tests to demonstrate the physical and functional performance of the device and its substantial equivalence to a predicate device.

Table: Acceptance Criteria and Reported Device Performance (from the document's perspective)

Additional Information Extracted from the Document:

• Sample size for the test set and the data provenance: Not applicable in the context of diagnostic data. The "tests" mentioned are engineering and material tests, likely involving a number of units of the device. There is no mention of patient data (retrospective/prospective, country of origin).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests are established engineering and material standards and specifications. Expertise would be in engineering and testing methodologies, not clinical diagnosis.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
• The type of ground truth used: Engineering specifications and ISO/ASTM standards for material and device performance.
• The sample size for the training set: Not applicable; this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

In essence, the provided document is a 510(k) clearance for a physical medical device (a thrombectomy system), not a diagnostic algorithm or AI product. Therefore, the "acceptance criteria" and "studies" refer to the physical and functional performance of the device itself, rather than its performance in interpreting medical data or assisting human readers.

Ask a specific question about this device