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The ZelanteDVT™ Thrombectomy System, which includes the ZelanteDVT™ Thrombectomy Set and the ClotHunter™ Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
· Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

The AngioJet™ ZelanteDVT Thrombectomy System is a component of the AngioJet Ultra Thrombectomy System (AngioJet Ultra System or System). The ZelanteDVT Thrombectomy System can only be used in conjunction with the AngioJet Ultra Console. The AngioJet ZelanteDVT Thrombectomy System is comprised of the single-use ZelanteDVT Thrombectomy Set and the single-use ClotHunter Helical Rotation Device. Both components are packaged and sold separately. The ClotHunter Helical Rotation Device can only be used in conjunction with the ZelanteDVT Thrombectomy Set.

The Thrombectomy Set uses this pressurized, high-velocity saline to create a low-pressure zone at the Catheter tip. Thrombus is drawn into the Catheter where it is fragmented by the jets and evacuated from the body. The waste tubing transports the thrombus debris from the Catheter to the waste bag for ultimate disposal.

The ClotHunter Helical Rotation Device consists of a distal helical-shaped wire portion attached to a control handle that is used with the ZelanteDVT Thrombectomy Set. The Helical Rotation Device deflects the distal tip of the Catheter and improves clot removal due to increased luminal coverage. The ClotHunter Helical Rotation Device extends beyond the distal tip of the Catheter to provide a transition between the Catheter and the vessel wall.

The provided text describes a 510(k) premarket notification for the ZelanteDVT™ Thrombectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device through bench, animal, and biocompatibility testing, rather than clinical studies involving human patients or complex AI-based performance metrics like sensitivity/specificity.

Therefore, the information requested in your prompt related to the acceptance criteria for an AI device, sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, and human reader performance improvement is not applicable to this specific device submission as described in the provided document.

The document states:

• "Bench, animal, and biocompatibility testing were performed to support a determination of substantial equivalence."
• "No new safety or performance issues were raised during the testing."

This indicates that the acceptance criteria and study design for this device revolved around engineering performance, material compatibility, and biological safety, as opposed to diagnostic accuracy or AI algorithm performance typically seen with AI-powered medical devices.

Summary of what can be extracted and what is N/A:

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

   • N/A. The document lists the types of tests performed (biocompatibility, in-vitro performance, GLP animal study), but it does not specify quantitative acceptance criteria or detailed numerical results for these tests. It broadly states that the results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised."

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

   • N/A (for human clinical data). The studies are described as "Bench, animal, and biocompatibility testing." There's no mention of a human test set in the context of device performance data, thus no data provenance or sample size for human data.

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

   • N/A. Ground truth in the context of diagnostic accuracy established by human experts is not relevant here as the testing is not for diagnostic performance of an AI.

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

   • N/A. Not applicable as there is no diagnostic test set requiring 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:

   • N/A. This applies to AI-assisted diagnostic devices. The ZelanteDVT™ Thrombectomy System is a mechanical thrombectomy device, not an AI diagnostic tool.

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

   • N/A. There is no algorithm to test standalone performance.

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

   • N/A. Not applicable in the context of a mechanical thrombectomy device's performance testing. The "ground truth" for this device would be established by direct measurement during bench testing (e.g., clot removal efficiency, wire whip force), and observations during animal studies.

8. The sample size for the training set:

   • N/A. No AI training set is mentioned or required for this type of device.

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

   • N/A. No AI training set.

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Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated. The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch and 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cm straight and J tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length. The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.

The provided text describes testing conducted for the InQwire Amplatz Super Stiff Guide Wire (K170700) to demonstrate its substantial equivalence to predicate devices, not specifically for a software algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable.

However, I can extract the information that is present regarding the acceptance criteria and the study performed for this medical device.

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes used for each performance test. It states that "A battery of testing was conducted" and implies these were laboratory-based tests comparing the subject device to existing predicate devices.

• Sample Size: Not specified.
• Data Provenance: The tests are implied to be conducted by the manufacturer, Merit Medical Systems, Inc., which has locations in South Jordan, UT, USA, and Galway, Ireland. The data is from laboratory testing of the physical device, not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a physical medical device, not an AI/software device requiring expert interpretation of results for ground truth. Therefore, this information is not applicable. Ground truth was established through validated engineering and scientific testing methods against established standards.

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

This is not applicable as it refers to expert consensus for interpreting results, which is not relevant for the performance testing of a physical guide wire.

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

This is not applicable as this is not an AI/software device.

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

This is not applicable as this is not an AI/software device.

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

The ground truth for the reported tests was established by:

• Reference to predicate devices (Merit InQwire® Amplatz Super Stiff Guide Wire [K163575] and Amplatz Super Stiff Guidewire [K843012]).
• Adherence to industry standards and guidance documents (e.g., FDA guidance Coronary and Cerebrovascular Guide Wire Guidance, ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006).
• Risk analysis.

The "ground truth" for a physical device is its measurable physical and chemical properties and performance characteristics against established benchmarks.

8. The sample size for the training set

This is not applicable as this is not an AI/software device.

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

This is not applicable as this is not an AI/software device.

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Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated.

The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch outer diameter with a 7cm straight tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length.

The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.

The provided text describes a 510(k) premarket notification for a medical device, the "InQwire Amplatz Super Stiff Guide Wire." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the requested information:

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

The document states that performance testing was conducted based on risk analysis and in accordance with protocols based on guidances and industry standards. It explicitly says: "these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."

However, the document does not provide a specific table detailing numerical acceptance criteria and a corresponding column for reported device performance values. It lists the types of tests performed but not the quantitative results or specific thresholds.

Table of Performance Tests Conducted (Acceptance Criteria and Numerical Performance Not Specified):

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

The document does not specify the sample size for any of the performance tests. It also does not mention data provenance such as country of origin of the data or whether the studies were retrospective or prospective. The testing appears to be primarily bench testing (in vitro) rather than human or animal studies, given the type of device and tests.

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

This section is not applicable as the document describes performance testing of a physical medical device (guide wire), not an AI/ML algorithm that requires expert "ground truth" for interpretation of images or other clinical data. The "ground truth" here is the physical performance of the device against engineering and material standards.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-AI reader studies. The performance tests described measure physical properties and do not involve human interpretation.

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

This is not applicable. The device is a guide wire, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study involving human readers and AI assistance would have been performed.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance testing is based on engineering standards, in vitro testing protocols, and comparison to legally marketed predicate devices. This includes:

• FDA guidance (e.g., Coronary and Cerebrovascular Guide Wire Guidance January 1995)
• Industry standards (e.g., ISO 11070:2014, ISO 11135-1:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006)
• Bench testing methodologies to evaluate physical and material properties (e.g., tensile strength, flexibility, radiopacity, coating adherence, biocompatibility, corrosion).

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable for the same reason as #8.

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