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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

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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.

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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 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.

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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.

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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.

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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.

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The InThrill™ Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft.

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

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

The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.

The InThrill™ Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. The system comprises two main components packaged separately:

• InThrill Sheath (8 Fr)
• InThrill Thrombectomy Catheter (8 Fr)

The InThrill Sheath is placed in the target vessel, and, after its funnel is expanded, the InThrill Catheter is inserted through the sheath and advanced past the thrombus. The InThrill Catheter coring element is deployed, providing wall-to-wall contact to engage the clot, and is then retracted into the InThrill Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the InThrill Catheter and InThrill Sheath are removed from the patient.

I'm sorry, but based on the provided FDA 510(k) clearance letter for the InThrill™ Thrombectomy System, there is no information available about acceptance criteria and a study that proves the device meets specific performance criteria for AI/ML-based medical devices.

This document describes a medical device (thrombectomy system) which is a physical, mechanical device, not an AI/ML-based software device. The entire document focuses on the substantial equivalence of the InThrill™ Thrombectomy System to a predicate device, based on non-clinical performance and biocompatibility testing.

Therefore, I cannot fulfill your request for the specific points related to AI/ML device testing, such as:

• A table of acceptance criteria and reported device performance related to AI/ML metrics.
• Sample size and data provenance for an AI/ML test set.
• Number of experts and their qualifications for AI/ML ground truth.
• Adjudication method for AI/ML test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone (algorithm only) performance for AI.
• Type of ground truth used for AI/ML.
• Sample size for training set and how ground truth was established for AI/ML.

The "Performance Tests" section in the document refers to engineering and functional performance tests for the physical device (e.g., tensile strength, luer connections, clot burden removal efficacy of the mechanical device), not the performance of an AI algorithm in interpreting medical images or data.

If you have a document pertaining to an AI/ML medical device, I would be happy to analyze it for the criteria you've outlined.

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The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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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 VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.

Based on the provided text, the device in question is the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System. This is a medical device, not an AI/ML powered device, therefore no acceptance criteria related to AI/ML device performance (like sensitivity, specificity, AUC, human reader studies etc.) are mentioned.

The information provided describes the regulatory submission for premarket notification (510(k)) of a medical device, asserting its substantial equivalence to a legally marketed predicate device. The document details the physical and functional characteristics of the device and how they compare to the predicate, as well as the non-clinical testing performed.

Therefore, the specific information requested in the prompt about acceptance criteria and study proving AI/ML device performance (e.g., acceptance criteria for AI performance metrics, sample size for test sets, expert adjudication, MRMC studies, standalone AI performance, ground truth establishment for AI models, training set details) is not applicable to this document as it pertains to a mechanical medical device, not an AI/ML powered one.

However, I can extract the general acceptance criteria and the type of study performed to prove this mechanical device meets its intended use, based on the non-clinical testing conducted.

Acceptance Criteria and Study for the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System

Given that the device is a mechanical thrombectomy system and not an AI/ML powered device, the "acceptance criteria" discussed in this document relate to the performance and safety of the physical device compared to its predicate, rather than AI-specific metrics. The "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance (Non-Clinical)

While an explicit, quantifiable table of acceptance criteria for performance metrics is not provided in a format typical for AI/ML devices, the document states that all necessary verification steps met "pre-determined acceptance criteria" to demonstrate substantial equivalence. The reported performance refers to the device passing simulated use tests.

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

• Sample Size for Test Set: The document mentions "non-clinical testing" and refers to "test units" without specifying precise numerical sample sizes. This typically refers to a number of physical device units tested in a lab setting.
• Data Provenance: The data is generated from non-clinical bench testing rather than patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable. It's laboratory-generated data.

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

• Not Applicable. As this is a mechanical device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The "ground truth" for performance is based on direct physical measurements, simulations, and engineering specifications.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for a test set, as this is bench testing of a physical device. Performance is objectively measured against specifications.

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

• No. An MRMC study is not mentioned because this is a mechanical device, not an AI/ML diagnostic system intended to assist human readers with interpretation.

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

• Not Applicable. This is a mechanical medical device, not an algorithm, so independent algorithmic performance is not relevant.

7. The Type of Ground Truth Used:

• For this mechanical device, the "ground truth" for performance and substantial equivalence is established through:
  • Bench Testing: Direct physical measurements, engineered simulations (e.g., simulated vessels, simulated thrombi), and performance against predefined engineering specifications.
  • Regulatory Standards: Compliance with relevant international standards (e.g., ISO 10993 for biocompatibility) and FDA guidance for medical device testing.
  • Predicate Device Performance: The predicate device itself serves as a "ground truth" benchmark for demonstrating substantial equivalence in function and safety.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" of data.

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

• Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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