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The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

The provided text is a 510(k) summary for a medical device (Excelsior XT-27 Microcatheters) and details its acceptance criteria and the study performed to demonstrate substantial equivalence, but it does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and data provenance) are not applicable to this document.

However, I can provide the acceptance criteria and study information that is available for this mechanical microcatheter from the document.

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):

• Sample Size for Test Set: The document does not specify the exact number of samples (e.g., number of microcatheters tested) used for each bench test. It mentions testing with "ancillary devices that represent worst-case sizes" for the Guide Catheter Compatibility test and "worst-case sized ancillary devices and interventional devices" for the Tensile Strength test.
• Data Provenance: The study is described as "Bench testing," indicating it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects.

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):

• Not applicable as this is a mechanical device performance study, not an AI/ML diagnostic or prognostic study requiring expert opinion for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

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

• Not applicable for the same reason as point 3. Bench testing results are typically adjudicated by meeting predefined engineering specifications and criteria, not by expert consensus in the same way as diagnostic reads.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices, which is not what this device is.

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

• Not applicable. This is a physical medical device (microcatheter), not an algorithm.

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

• The "ground truth" in this context is based on engineering specifications and performance criteria for the physical device. For example, for tensile strength, the ground truth would be a defined minimum force the joints and marker band must withstand without failure. For compatibility, it would be the ability to successfully deliver and retrieve the microcatheter within the specified guide catheter with acceptable force.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable for the same reason as point 8.

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The AXS Lift Intracranial Base Catheter is introduction of interventional devices into the peripheral and neurovasculature.

The AXS Lift Intracranial Base Catheter ("AXS Lift") is a single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neurovasculature. The distal catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end. The distal end of the catheter contains bovine derived tallow. It is packaged with one double port rotating hemostasis valve (RHV) and one peel-away introducer sheath. The peel-away introducer sheath is designed to protect the distal tip of the catheter during insertion into the short introducer sheath valve. The AXS Lift Intracranial Base Catheter is compatible with short introducer sheaths with an inner diameter of 7Fr or greater. AXS Lift is supplied sterile, non-pyrogenic, and is intended for single use only.

The provided text, K243593 for the AXS Lift Intracranial Base Catheter, describes the predicate device equivalence testing rather than a study proving the device meets acceptance criteria for an AI/ML algorithm. The document focuses on the mechanical and material performance of a catheter, not the performance of a software algorithm.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), cannot be extracted from this document as it does not contain information about an AI/enabled medical device.

The document definitively states on page 9:

"No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."

This reinforces that the approval is based on physical and material device characteristics, not an AI/ML algorithm's performance on clinical data or human-in-the-loop studies.

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The Echo Intracranial Base Catheter is indicated for the introduction of interventional devices into the neurovasculature.

The Echo Intracranial Base Catheter is a single lumen, flexible, variable stiffness catheter with a 0.100 inch inner diameter, designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the neurovascular system. It has a radiopaque marker band on the distal end a luer hub at the proximal end. The distal catheter shaft has a 14 cm lubricious coating to reduce friction during use. It is packaged with a dilator and two rotating hemostatic valves. The Echo Intracranial Base Catheter is compatible with introducer sheaths with an inner diameter of 9F or greater. The Echo Intracranial Base Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text describes a medical device called the "Echo™ Intracranial Base Catheter", but it does not contain the acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

Instead, the document is a 510(k) premarket notification for a traditional medical device (a catheter) and discusses its substantial equivalence to a predicate device. It details bench testing, animal safety testing, biocompatibility, sterilization, and shelf life, which are standard for such device submissions. It does not mention any AI component or software, nor does it refer to acceptance criteria in the context of device performance metrics like sensitivity, specificity, or any other statistical measure typically used for AI/software-driven diagnostic or assistive tools.

Therefore, I cannot extract the requested information regarding AI acceptance criteria or studies from this document.

If you have a document describing an AI-driven device and its performance studies, please provide that text.

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The Broadway 8 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.

The Broadway 8 Catheter is a single lumen, flexible, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The Broadway 8 Catheter shaft has a lubricious hydrophilic coating at the distal end to reduce friction during use. It is packaged with a FastPass Delivery Assist Catheter, two rotating hemostasis valves (RHVs) and two peel-away introducer sheaths.

The FastPass Delivery Assist Catheter may be used in conjunction with the Broadway 8 Catheter to facilitate the introduction of the Broadway 8 Catheter into distal vasculature and aid in navigation to distal anatomy. The FastPass Delivery Assist Catheter has a lubricious hydrophilic coating at the distal end to reduce friction during use.

The provided text is a 510(k) summary for the Stryker Neurovascular Broadway 8 Catheter. It outlines the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence. However, this document does not describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

The acceptance criteria tables and study details typically requested for AI/ML device performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment by multiple experts, sample sizes for training and test sets, etc.) are not applicable to this 510(k) summary, as the Broadway 8 Catheter is a physical medical device (a percutaneous catheter), not an AI/ML software device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance related to AI/ML metrics. The performance data provided is for physical bench testing (e.g., tensile strength, particulate, kink resistance) and an animal study assessing vascular safety, which are relevant to a catheter but not to AI/ML performance.
• Sample sized used for the test set and the data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set sample size, and how training ground truth was established. These details are specific to the development and validation of AI/ML algorithms and are not found in the provided document for this physical device.

The document focuses on demonstrating substantial equivalence of the catheter to a predicate device through:

• Bench Testing: Verifying physical properties, mechanical integrity, and material characteristics (e.g., Dimensional Verification, Tensile Strength, Particulate, Coating Integrity, Kink Resistance, Burst Pressure, Simulated Use Testing).
• Animal Study: Assessing vascular safety and navigation performance in a swine model compared to the predicate device.
• Biocompatibility Testing: Ensuring the materials are safe for biological interaction.

The "Conclusions" section reiterates that the device is substantially equivalent based on these aspects, not on AI/ML performance.

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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.

2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

The acceptance criteria for the Trevo NXT ProVue Retriever are not explicitly stated in numerical thresholds within the provided text. However, the document asserts that the device is substantially equivalent to its predicate device (K210502) and that the performance is "similar" to established safety and performance profiles. The primary change supported by this submission is a labeling modification concerning the minimum vessel diameter for certain models.

Here's an attempt to structure the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or numerical performance metrics for the Trevo NXT ProVue Retriever. Instead, it relies on demonstrating substantial equivalence to a predicate, particularly in the context of a labeling change for compatibility. The "performance" assessment is qualitative, focusing on "similar performance and safety profile".

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

• Test Set Description: A "retrospective analysis of device performance per vessel size" was conducted.
• Sample Size: Not explicitly stated. The analysis was performed "using The ASSIST Registry data." The number of cases or patients included in this retrospective subgroup analysis is not provided.
• Data Provenance: Retrospective. The country of origin of "The ASSIST Registry" data is not specified in the provided text.

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

• The document does not mention the use of experts to establish ground truth for "The ASSIST Registry data" specifically for this retrospective analysis. The data from "The ASSIST Registry" would presumably have its own established ground truth generated during data collection, but this is not detailed here. The submission focuses on analyzing existing data.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study involved a retrospective analysis of registry data, not a new dataset requiring expert adjudication for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study was a retrospective analysis of an existing registry.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The device is a mechanical thrombectomy device, not an algorithm or AI. The "performance" refers to the clinical effectiveness of the physical device.

7. The Type of Ground Truth Used

• For the retrospective analysis of "The ASSIST Registry data," the ground truth would be the clinical outcomes data and procedural data recorded within that registry. For example, successful recanalization (restoring blood flow), reduction in disability, and safety events (as mentioned in "similar performance and safety profile").

8. The Sample Size for the Training Set

• Not applicable. The device is a physical 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. (See #8)

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Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Detachable Coils are indicated for endovascular embolization of:

• Intracranial aneurysms
• . Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra (Subject Device). All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coils with the Tetrahedral shape, the distal end of the main coil is formed such that the diameter of the distal loop is approximately 75% that of the overall secondary outer diameter (OD) size.

The provided text describes a 510(k) premarket notification for the "Target Tetra Detachable Coils" (K222533), a neurovascular embolization device. The document focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing. It does not describe an AI/ML-based device or a study involving human readers or AI assistance. Therefore, information related to AI/ML acceptance criteria, ground truth establishment for AI, sample sizes for AI training/test sets, expert adjudication, or MRMC studies is not present in the provided document.

The document does provide information on the performance data collected to support the substantial equivalence claim for this medical device.

Here's an analysis of the provided text, extracting the relevant information within the scope of the original request, focusing on the device performance and acceptance criteria where applicable to the physical medical device described:

Acceptance Criteria and Device Performance

The document states that the "Target Tetra Detachable Coils" are substantially equivalent to their predicate devices. The performance data is primarily from bench testing and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML):

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

• Test Set Sample Size: The document does not specify the exact number of units tested for each bench test. It generally states that "performance bench testing has demonstrated" the results.
• Data Provenance: This is a physical medical device. The data comes from bench tests conducted by Stryker Neurovascular. The document does not specify the country of origin for the testing, but the company is based in Fremont, California, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission.

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

• Not Applicable. This is a physical medical device, not an AI/ML device requiring clinical expert ground truth for interpretation. Performance is measured against engineering specifications and physical properties.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

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

• No. This is not an AI/ML device; therefore, an MRMC study related to readers improving with AI assistance would not be applicable. The document explicitly states: "No clinical study was conducted because bench testing was determined sufficient to support substantial equivalence to the predicate device."

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

• Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• For physical properties and mechanical performance: Engineering specifications, established test methods, and comparison data from predicate devices serve as the "ground truth" or reference for evaluating performance parameters.
• For biocompatibility: International standards (EN ISO 10993-1:2020) and FDA guidance documents serve as the ground truth.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The "training" or development of the device would involve engineering design and prototyping.

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

• Not Applicable. See point 8. The "ground truth" for developing a physical medical device involves scientific principles, material properties, biomechanical considerations, and clinical needs, leading to design specifications.

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The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a Luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.

The provided text describes the regulatory filing for the Trevo Trak 21 Microcatheter (K211594), which is a device intended for selective placement of devices and/or fluids in vasculature. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192122), particularly concerning a change in the recommended minimum inner diameter of the guide catheter.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria specified are primarily related to general device performance and safety rather than a specific algorithmic output, as this is a physical medical device (microcatheter) and not an AI/ML powered device. The "reported device performance" refers to the results of bench testing.

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

The document does not explicitly state the numerical sample sizes for each bench test conducted on the Trevo Trak 21 Microcatheter (K211594). It mentions that the testing was performed to assess compatibility with a 0.046 inch inner diameter (ID) guide catheter.

• Test Set Sample Size: Not explicitly stated for K211594's current submission. The wording "User will assess Trevo Trak™ 21 Microcatheter with a worst case compatible guide catheter" suggests a focus on representative scenarios but not a specific 'n' number.
• Data Provenance: The bench testing appears to be prospective and conducted by Stryker Neurovascular themselves, as part of their submission for K211594. The location of the testing is not specified, but the manufacturer is based in Fremont, California, USA. The shelf-life, sterilization, and biocompatibility data referenced previous testing in K192122, suggesting retrospective use of that data for the current submission.

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

This section is not applicable as the device is a physical medical instrument, not an AI/ML algorithm requiring expert interpretation of results for ground truth establishment. The "ground truth" for the performance tests relies on established engineering and materials science principles and validated test methods.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. The assessment of bench test results involves direct measurements, visual inspections, and adherence to predefined engineering specifications, not expert consensus 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

This is not applicable. The Trevo Trak 21 Microcatheter is a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

This is not applicable as the device is a physical medical device and does not involve any algorithm.

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

The "ground truth" for this device's performance is based on engineering specifications, recognized national/international standards (e.g., ISO 14971 for risk assessment, ISO 10993-1 for biocompatibility), and validated test methods. The successful meeting of these criteria serves as the basis for claiming safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

This is not applicable for the same reasons as point 8.

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The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Stryker Neurovascular's InZone® Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

Here's an analysis of the provided text regarding the InZone Detachment System, focusing on acceptance criteria and the supporting study:

The provided document (K212455) is a 510(k) summary for modifications to the InZone Detachment System. It does not describe a study involving human readers or AI. Instead, it focuses on bench testing and software verification to demonstrate substantial equivalence to a predicate device after firmware modifications. The device is a medical instrument used for detaching coils in neurovascular procedures, not an AI or imaging diagnostic tool. Therefore, many of the requested points related to AI, ground truth establishment, expert consensus, and MRMC studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly treats the successful completion of the listed verification tests as meeting acceptance criteria, demonstrating the modified device functions as intended and is substantially equivalent to the predicate.

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

The document does not specify a "test set" in the context of patient data or clinical images. The testing described is primarily bench-top testing of the device's firmware and physical characteristics. Therefore, there is no mention of country of origin or whether data was retrospective or prospective in the clinical sense. The "test cases" for software and bench-top testing would refer to specific scenarios and conditions the device was put through. The number of iterations or specific samples for each bench test (e.g., how many coils were detached for detachment consistency) is not provided.

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

Not applicable. This device is an instrument, not an AI diagnostic tool requiring expert interpretation of medical data for ground truth. Ground truth for the device's functionality would be established by engineering specifications, proper electrical readings, and functional verification, typically performed by engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in the context of expert review. The device's performance is objectively measured against engineering specifications.

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 not an AI diagnostic device, and no MRMC study was performed. The device is a tool used by interventionalists, and the study focuses on its functional performance, not its impact on human reader effectiveness for diagnosis.

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

This refers to the performance of the device itself (the "algorithm" being its firmware). The "Verification Testing" detailed in the table above is a standalone assessment of the device's performance. It evaluates the device's ability to perform its functions (detachment, detection, safety features) without human intervention beyond initiating the process.

7. The Type of Ground Truth Used

The ground truth used for the verification testing (standalone performance) is based on engineering specifications and expected functional outcomes. For example:

• Detachment cycle time: Should fall within a defined range.
• Max voltage/current output: Must not exceed specified limits.
• Low battery detection: Must accurately signal when battery is low.
• Fault detection: Must correctly identify and signal specified faults.
• Delivery wire compatibility and detection: Must correctly identify and interface with different coil types.

These ground truths are derived from existing design requirements, safety standards (e.g., ISO 14971, EN 62304), and the established performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI system that undergoes "training" with data in the conventional machine learning sense. Its firmware is programmed based on design specifications and engineering principles.

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

Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the device's design and programming comes from established medical device standards, functional requirements for electrolytic detachment, and the performance characteristics of the previously cleared predicate device.

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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

Here's a breakdown of the acceptance criteria and study information for the Trevo NXT ProVue Retriever, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on establishing substantial equivalence to a predicate device, specifically regarding a change in labeling for compatibility with smaller aspiration catheters. It doesn't explicitly state quantitative acceptance criteria for primary clinical endpoints of the device itself in the context of a de novo submission. Instead, it demonstrates through comparative data that the modified use case (with smaller catheters) maintains equivalent performance to the established use case.

Study Information

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

   • Test Set A (Simulated Use & Particulate Characterization): Sample sizes are not explicitly stated, but these were bench tests performed by Stryker Neurovascular.
   • Test Set B (Animal Study): Sample size for the animal study is not specified.
   • Test Set C (Real-World Data - RWD):
     • An administrative claims database (details regarding country/scope not specified).
     • Post-market registries: "The Trevo Retriever Registry" and "The ASSIST Registry" (details regarding country/scope not specified).
     • Retrospective data, as it's an "analysis of Real-World Data (RWD) from an administrative claims database, post-market registries...as well as a review of relevant literature."

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

   • The document does not specify the number or qualifications of experts for establishing ground truth for any of the clinical/RWD test sets. The RWD analysis likely used existing clinical outcomes as "ground truth." For bench and animal studies, "ground truth" would be determined by the study design and measurements.

3. Adjudication Method for the Test Set:

   • The document does not describe any adjudication method for the RWD or registry data.

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

   • No, an MRMC comparative effectiveness study involving human readers or AI assistance in that direct context was described. The RWD analysis was focused on the device's performance with different aspiration catheter sizes, not on human-AI interaction.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. The device is a physical neurovascular mechanical thrombectomy device, not an algorithm. The "performance data" refers to the device's efficacy and safety in its intended use.

6. Type of Ground Truth Used:

   • Bench Testing: Internal performance criteria and measurements.
   • Animal Study: Evaluation of vascular trauma, recanalization, and distal emboli based on experimental observations.
   • Real-World Data (RWD):
     • Patient outcomes data from an administrative claims database.
     • Revascularization rates (eTICI>2c) and 90-day Modified Rankin Scale (MRS) from post-market registries and relevant literature. This would be considered outcomes data.

7. Sample Size for the Training Set:

   • Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The document refers to testing data to support a change in labeling for compatibility.

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

   • Not applicable, as there is no "training set" for this physical device.

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The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Internediate Catheter is also indicated for use as a conduit for retrieval devices.

The AXS Vecta 46 Intermediate Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta 46 Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal 25cm) to reduce friction during use. It is packaged with one hemostasis valve, and one peel-away introducer.

The provided text does NOT describe an AI/ML powered medical device, therefore, a detailed response regarding acceptance criteria for such a device, including sample size, expert ground truth, MRMC study, and training set information, cannot be extracted.

The document discusses the substantial equivalence of the AXS Vecta 46 Intermediate Catheter to existing predicate devices. This is a physical medical device (a catheter) and its clearance is based on bench testing (simulated use, burst testing, particulate testing), animal studies, and shelf-life testing, not on AI/ML performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets acceptance criteria based on this input. The information requested (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) is specific to AI/ML device evaluations and is not relevant or present in this document about a physical catheter.

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