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The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

• Failure of anticoagulant therapy in thromboembolic disease

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

· Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

· Failure of anticoagulant therapy in thromboembolic disease

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

· Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.

The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker.

The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

This document describes a 510(k) premarket notification for the Option™ELITE Vena Cava Filter System and Option™ELITE Vena Cava Filter 100cm System. The purpose of the submission is to incorporate results from the PRESERVE study summary data into the Instructions for Use (IFU).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not include a specific table of acceptance criteria or reported device performance metrics in the traditional sense of a performance study. This submission is for incorporating existing clinical study results (PRESERVE study) into the device's labeling, rather than presenting new performance data for a modified device. The document explicitly states:

"No new operating principles have been introduced with the subject device. The subject device operates using the identical fundamental scientific technology as the predicate device; therefore, no performance testing was necessary nor was any performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption and the PRESERVE study."

Because no new performance testing was conducted for this specific 510(k) submission, there are no new device performance metrics to report against an acceptance criterion in this document. The existing performance would be based on the prior clearance of the predicate devices and the PRESERVE study.

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

The document refers to the "PRESERVE study." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for this study within the provided text. To obtain this information, one would need to consult the original PRESERVE study documentation.

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

The provided document does not contain information on the number of experts used to establish ground truth or their qualifications for the PRESERVE study's test set.

4. Adjudication Method for the Test Set

The provided document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set of the PRESERVE study.

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

An MRMC comparative effectiveness study is typically used for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. Since the device is a Vena Cava Filter System, it is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, no MRMC comparative effectiveness study was done for this device.

6. Standalone (Algorithm Only) Performance

The device is a physical Vena Cava Filter System, not an algorithm or software-only device. Therefore, the concept of "standalone performance" for an algorithm does not apply to this device.

7. Type of Ground Truth Used

Given that this is a physical medical device (vena cava filter) and the PRESERVE study would be a clinical trial, the "ground truth" would likely be derived from patient outcomes, imaging data, and clinical assessments related to the filter's effectiveness in preventing pulmonary embolism and its safety profile. However, the document does not explicitly state the type of ground truth used for the PRESERVE study.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. Since the device is a physical medical device and not an AI/ML product, no training set was used in the context of algorithm development. Clinical trials, like PRESERVE, gather data for validation and effectiveness, not for training an algorithm.

9. How Ground Truth for the Training Set Was Established

As noted above, no training set was used in the context of an algorithm for this physical device. Therefore, how ground truth for a training set was established is not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device and incorporating pre-existing clinical study (PRESERVE study) data into the device's labeling. It does not present new performance data or detail the methodology of the PRESERVE study in the way one might expect for a new device's initial clearance or an AI/ML product. To get specific details about the PRESERVE study (sample size, ground truth, expert involvement, etc.), one would need to refer to its full study report or publications.

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The TLAB® Transvenous Liver Biopsy System is intended to be used for percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures.

The TLAB® Transvenous Liver Biopsy System is a single use, disposable, sterile device. The TLAB® Transvenous Liver Biopsy System consists of the following components: 18-Gauge (18Ga) Flexcore Biopsy Needle, 7 French (7Fr) Introducer Sheath with a curved metal stiffener, 5 French (5Fr) Straight Catheter, 5 French (5Fr) Curved Catheter, Tissue Removal Swabs, Bending Tool (used for transfemoral access).

Here's a breakdown of the acceptance criteria and study information for the TLAB® Transvenous Liver Biopsy System, based on the provided text:

This document describes a medical device (TLAB® Transvenous Liver Biopsy System) not an AI/ML device, therefore, sections related to AI/ML specific criteria (such as MRMC studies, standalone algorithm performance, training set details) are not applicable.

Acceptance Criteria and Reported Device Performance

Device Trade Name: TLAB® Transvenous Liver Biopsy System (TF-18C)
Regulation Number: 21 CFR 870.1340 - Catheter Introducer
Regulatory Class: Class II
Product Code: DYB

The device demonstrated substantial equivalence to predicate devices (TLAB® Transjugular Liver Access Set K022634 and Traveler Portal Vein Access Set K213638) based on a comparison of technological characteristics, indications for use, materials, packaging, principle of operation, design features, sterilization process, and in-vitro performance testing.

Study Details

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

   • The document primarily describes bench-top testing (in-vitro performance) and biocompatibility testing. Specific sample sizes for each non-clinical test are not explicitly stated in the provided text, but it mentions that "A series of testing was conducted".
   • Data Provenance: All studies were performed following approved protocols under Good Laboratory Practices (GLP) in compliance with FDA GLP, 21 CFR Part 58. This indicates the testing was conducted in a controlled laboratory environment. No specific country of origin or retrospective/prospective nature for these non-clinical tests is given beyond GLP compliance.

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

   • This question is not applicable as the described studies are non-clinical, bench-top performance and biocompatibility tests. They do not involve human interpretation or subjective clinical "ground truth" that would require expert consensus. The acceptance criteria themselves serve as the 'ground truth' for these engineering and materials tests.

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

   • This question is not applicable as the described studies are non-clinical, bench-top performance and biocompatibility tests. Adjudication methods are typically used in clinical studies or studies involving subjective human interpretation (e.g., image reading) where disagreement among experts needs resolution.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. Therefore, no MRMC comparative effectiveness study was performed in the context of AI assistance.

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

   • This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. There is no algorithm to test in a standalone manner.

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

   • For Performance Testing: The "ground truth" is defined by the acceptance criteria established in accordance with protocols based on guidance and industry standards. These include established engineering and material science standards (e.g., ISO for luer, catheter, and breakage testing) that define acceptable performance.
   • For Biocompatibility Testing: The "ground truth" is defined by the internationally recognized standards for biocompatibility (ISO 10993 series) and FDA Guidance, which specify test methods and acceptable limits for biological responses.

7. The sample size for the training set:

   • This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. There is no machine learning model that requires a training set.

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

   • This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device.

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The Cleaner™ Plus 18F Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ 18F Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.

The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes an aspiration control and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum reservoir with pump known as the Aspiration Canister.

The system is inserted percutaneously into the vessel using an introduction catheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and wall adherent thrombus with a maceration wire. The macerated thrombus is removed from the vessel using an aspiration system. The aspiration of the clot can be performed simultaneous or independently.

Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.

The provided text describes information about the Cleaner™ Plus 18F Thrombectomy System, a medical device, and the basis for its FDA clearance through a 510(k) premarket notification (K233909). The information primarily focuses on establishing substantial equivalence to a predicate device (K211798), rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested items related to AI/ML device study design (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this document, as it concerns a mechanical thrombectomy system, not an AI/ML-driven device.

However, I can provide the available information regarding the device's performance assessment and the basis for its clearance.

Acceptance Criteria and Device Performance (Non-AI/ML Medical Device)

The document does not present a table of numerical "acceptance criteria" in the same way one might find for an AI/ML model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are qualitative, based on established industry standards, guidance, and the successful outcome of various performance and safety tests demonstrating substantial equivalence to a predicate device.

The "reported device performance" refers to the successful completion and meeting of predefined parameters for each test, indicating the device performs as intended and is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical device, not an AI/ML system, the "acceptance criteria" are the successful completion of various tests and the demonstration of substantial equivalence. The "reported device performance" refers to the outcomes of these tests.

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The Cleaner™ Pro Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The Cleaner™ Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary embolism.

The Cleaner Pro Thrombectomy System is a single use device in the removal of fresh, soft emboli and thrombi and for the infusion of physician-selected fluids through the side-port of the aspiration catheter.

The disposable system consists of: (1) the Aspiration Catheter with Dilator, (2) the Handpiece with Flushing Adapter, and (3) the external vacuum reservoir with pump known as the Aspiration Canister.

The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the target site. Once in the target site, to complete the system, the Aspiration Canister is connected to the handpiece. The dilator is removed, and the device is activated by the user to aspirate soft emboli and thrombi. The clot is aspirated from the distal portion of the device through the handpiece and then collected in the aspiration canister reservoir.

Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.

The provided text is a 510(k) Summary for the Cleaner™ Pro Thrombectomy System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria based on clinical outcomes or standalone AI algorithm performance.

Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not present in this type of regulatory submission. This document describes the bench-top and animal performance testing to support the claim of substantial equivalence for a medical device, which is different from studies demonstrating efficacy of an AI algorithm or performance directly tied to a specific set of clinical acceptance criteria.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria with quantitative performance metrics for a clinical outcome study. Instead, it lists performance testing conducted to demonstrate substantial equivalence to the predicate devices. The acceptance criteria for these tests are generally that the device performs comparably to the predicate or meets established engineering/design specifications for safety and functionality.

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The 10F Sheath and Dilator Set is indicated for introduction of therapeutic devices into the vasculature, excluding coronary and neuro vasculature.

The 10F Sheath and Dilator Set is designed for single use and intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The 10F Sheath and Dilator Set consists of a 10F reinforced Introducer Sheath and a matching 10F radiopaque Dilator.

The 10F Introducer sheath is a coil reinforced sheath with a Platinum Iridium radiopaque marker band. The sheath has a hemostasis valve and a side port with stopcock. The 10F dilator is made of radiopaque, non-reinforced material with an atraumatic tip to minimize blood loss. The device does not include any coating.

The provided document describes a 510(k) premarket notification for the "10F Sheath and Dilator Set" and establishes its substantial equivalence to a predicate device based on in vitro performance testing and technological characteristics. It does not include information about an AI-powered device or a study proving that an AI device meets acceptance criteria. Thus, I cannot populate the requested table or answer the questions related to AI device performance.

However, I can extract the acceptance criteria and the study performed for the 10F Sheath and Dilator Set (a non-AI medical device).

1. Table of Acceptance Criteria and Reported Device Performance

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Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.

The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are single use devices. The disposable system consists of: [A] 9F (ID) Inner Sheath, [B] 11F (ID) Outer Sheath, [C] 8F (OD) Dilator, [D] Hemostasis Valve with Sideport, [E] High Pressure Stopcock, [F] 7F [2.4mm] (OD) x 76cm Snare Catheter with Tuohy-Borst Y-Port Adapter, 20mm x 93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fully expanded) with Torque Handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization.

The provided text describes a 510(k) premarket notification for a medical device, specifically retrieval kits for inferior vena cava (IVC) filters. The submission focuses on a modification to an existing device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a modification to an existing device, the "acceptance criteria" are not explicitly stated as numerical targets in a table. Instead, the acceptance criteria are implicit in meeting the performance standards of the predicate device and ensuring the modification doesn't negatively impact safety or effectiveness. The reported device performance is that all tests met their respective acceptance criteria.

The document explicitly states: "Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications."

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

The document does not specify the exact sample sizes used for each individual non-clinical test. It only lists the types of tests performed. The data provenance is not explicitly mentioned in terms of country of origin, but it is implied to be from the manufacturer's internal testing. The tests are non-clinical (bench testing, biocompatibility) rather than human subject studies, so the terms "retrospective or prospective" are not applicable in this context.

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

This information is not applicable to this submission. The tests performed are non-clinical (mechanical, materials, biocompatibility) and do not involve expert interpretation or ground truth establishment in the way clinical studies with AI algorithms would. The "ground truth" for these tests is based on objective measurements against established engineering and biocompatibility standards (e.g., ISO and ASTM standards).

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (retrieval kit) with a material modification, not an AI-powered diagnostic or interpretive device. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence."

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

A standalone performance study was not done. This is not an AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and standards: For mechanical and dimensional tests (e.g., tensile strength, leak test, burst test, radiopacity, Luer testing, flexural modulus, radial force).
• Biocompatibility standards: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, hemocompatibility).
• Simulated use conditions: For tests like simulated use and design validation.

8. The Sample Size for the Training Set

This is not applicable as this is not an AI device and therefore has no "training set."

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

This is not applicable as this is not an AI device and therefore has no "training set" or associated ground truth establishment process.

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The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the wire device placement. The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Mechanical thrombectomy is achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

The provided text describes a 510(k) submission for a device modification to the Cleaner Plus™ Thrombectomy System. This is a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm-only) performance," and "ground truth for the test and training set," are not applicable.

The submission focuses on demonstrating the substantial equivalence of a modified device to a predicate device through non-clinical performance testing.

Here's the relevant information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Test results demonstrate that all acceptance criteria were met." However, the specific acceptance criteria values are not detailed in the provided text. The types of tests performed indicate the areas for which acceptance criteria would have been established.

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

The document does not specify the sample sizes for the individual tests. The tests were non-clinical (laboratory/bench testing), so data provenance from countries or whether it was retrospective/prospective is not applicable in the typical sense.

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

Not applicable, as this is a medical device performance study, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. Adjudication methods are typically for clinical studies or studies involving expert interpretation, not for bench testing of device components.

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. This is a medical device, not an AI/ML system.

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

Not applicable. This is a medical device, not an AI/ML system.

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

The documentation did not specify a "ground truth" in the context of clinical or diagnostic outcomes. For performance testing of a physical device, the "ground truth" would be established physical measurements and material properties relevant to the device's function and safety (e.g., tensile strength, torque, aspiration volume, biocompatibility assays).

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set with established ground truth.

Summary of Study Type:

The study described is a non-clinical verification testing of a medical device modification to support substantial equivalence to a predicate device. The tests included various engineering performance tests (e.g., corrosion, tensile, torque, fatigue, simulated use) and biocompatibility assessments. Clinical and animal testing were not required for this determination of substantial equivalence.

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The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids. including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.

The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister.

The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

The provided text describes the evaluation of a medical device, the Cleaner Plus™ Thrombectomy System, for substantial equivalence to predicate devices, as part of an FDA 510(k) submission. This document is a regulatory submission, and as such, it focuses on non-clinical data (bench-top and animal studies) rather than clinical study data involving human patients or complex AI performance metrics.

Therefore, many of the requested points related to AI performance, human reader studies (MRMC), data provenance, expert consensus on ground truth, and training data for AI models are not applicable to this type of medical device submission.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is relevant in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The document details non-clinical performance tests that were conducted and states that the device "were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list quantified acceptance criteria for each test or detailed performance results in a table format. Instead, it lists the types of tests performed.

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The Scorpion Portal Vein Access Sets are intended for transjugular liver access in diagnostic and interventional procedures.

The Scorpion Portal Vein Access Sets have two models. One model has a Stylet as the puncture tool and the other model has a 17ga Needle as the puncture tool. The Scorpion Stylet Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA catheter, a 14ga Stiffening Cannula, a 0.040" Nitinol Stylet with a 5Fr PEEK Catheter, and a 7F Cannula Sheath. The 14ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171") sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Stylet Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (0.040" Stylet) through the parenchyma. The puncture tool (Stylet) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Stylet Portal Vein Access Set components are removed.

The Scorpion Needle Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA Catheter, a 13ga Scorpion Stiffening Cannula, 17ga Nitinol Needle, a 6.2F PEEK Catheter, and 8F Sheath Introducer. The 13ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 17ga Nitinol Needle has a directional handle that indicates the direction of the 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171″) sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Needle Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (17ga Needle) through the parenchyma. The puncture tool (Needle) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Needle Portal Vein Access Set components are removed.

A Portal Vein Access Set is typically in use in procedures up to 4 hours.

The provided document is a 510(k) summary for the Scorpion Portal Vein Access Set. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

For medical devices applying for 510(k) clearance, the primary study conducted is generally non-clinical performance testing and biocompatibility testing, rather than clinical studies involving human patients or complex AI algorithm performance analysis. The goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove superior or improved efficacy through a comparative effectiveness study involving human readers with and without AI assistance.

Therefore, the requested information pertaining to AI studies (MRMC studies, standalone AI performance, number of experts for ground truth, sample size for training set, etc.) is not applicable to this type of device clearance.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets those criteria:

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

The document lists various performance and biocompatibility tests conducted to demonstrate substantial equivalence to the predicate device. For each test, the implicit acceptance criterion is that the device meets the requirements outlined in the protocols based on guidances and industry standards. The reported device performance is stated as "shown to meet the acceptance criteria" or "meets the requirements for its intended use." Specific quantitative results or detailed pass/fail thresholds for each individual test are generally not included in a 510(k) summary, as it focuses on the conclusion of equivalence rather than the raw data.

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

The document does not specify the precise sample sizes for each of the non-clinical performance or biocompatibility tests. These tests typically involve a defined number of devices or material samples as per the relevant ISO or ASTM standards.

Regarding data provenance, the testing was conducted non-clinically and is typically performed at the manufacturer's facility or by a contract testing organization. The document refers to "protocols based on requirements outlined in guidances and industry standards," implying controlled laboratory settings. There is no mention of geographical data provenance for test sets (e.g., country of origin), as this is not a clinical study. The studies are prospective in the sense that they were designed and executed to specifically test the device for this submission.

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

This question is not applicable as this is a 510(k) submission for a physical medical device (catheter introducer) and involves non-clinical performance and biocompatibility testing, not AI/imaging studies that require expert annotation for ground truth.

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

This question is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials or imaging studies where human interpretation or consensus is required to establish ground truth or assess outcomes. These are not relevant for bench testing of physical device properties.

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 comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices or imaging interpretation aids, which is not the case for the Scorpion Portal Vein Access Set. The device is a surgical access tool, not an AI or imaging product.

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

No, a standalone algorithm performance study was not done. This device does not incorporate an AI algorithm.

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

For the non-clinical performance and biocompatibility tests, the "ground truth" is established by the defined acceptance criteria within established industry standards (e.g., ISO, ASTM) and internal protocols. For example, a tensile strength test would have a specified minimum breaking strength required by the device's design specifications. Biocompatibility tests have specific endpoints and thresholds defined by ISO 10993 series standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth as these are not clinical or diagnostic studies.

8. The sample size for the training set

This question is not applicable. This device is a physical medical device and does not involve AI algorithms that require a "training set."

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

This question is not applicable for the reasons stated above.

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The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) Microsnare Catheter, (1) Introducer and (1) Torque Handle. The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheter without risk of microsnare deformation because of the snare's super-elastic construction. The microsnare catheter is constructed of flexible tubing and contains a radiopaque marker band.

The Halo™ Single-Loop Microsnare Kit underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. No clinical studies were conducted, thus, information regarding human readers or effect sizes with AI assistance is not available.

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

The document indicates that acceptance criteria were determined to demonstrate substantial equivalence, and the device was shown to meet these acceptance criteria. However, specific numerical acceptance criteria and reported performance values for each test are not provided in the given text. Instead, the document lists the types of performance tests conducted.

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

The document does not specify the sample sizes used for each non-clinical test. The data provenance is non-clinical, meaning it comes from laboratory or bench testing rather than patient data.

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

This information is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies involving expert assessment of medical images or patient data.

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

This information is not applicable as the studies were non-clinical performance and biocompatibility tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was conducted. The device is a medical instrument (microsnare kit), not an AI-powered diagnostic tool. The document focuses on demonstrating the physical and biological characteristics of the device.

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

This is not applicable since the device is a medical instrument, not an algorithm. The performance tests evaluate the physical characteristics and biocompatibility of the device itself.

7. The type of ground truth used:

For performance testing, the "ground truth" would be established engineering specifications, industry standards, and regulatory requirements against which the device's physical and mechanical properties are measured. For biocompatibility testing, the "ground truth" is established biological responses as defined by ISO standards.

8. The sample size for the training set:

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

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

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

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