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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 peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

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

The Scout Introducer may be used in conjunction with the AXS Vecta Intermediate Catheter to facilitate in the introduction of the AXS Vecta Intermediate Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious hydrophilic coating at the distal end to reduce friction during use. The inner lumen of the AXS Vecta Intermediate Catheter is compatible with the Scout Introducer, guide wires and microcatheters. The inner lumen of the Scout Introducer is compatible wires and microcatheters of an outer diameter of less than 0.044in.

The AXS Vecta Intermediate Catheter's acceptance criteria and the studies proving it meets them are described below. The device is not an AI/ML device, so certain categories will be marked as "Not Applicable".

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily refers to "test samples" for bench testing and does not explicitly state the numerical sample size for each bench test. For the "Simulated Use" test, it mentions "All test samples," implying N > 1, but the exact number isn't provided.

• Particulate Characterization: Not explicitly stated.
• Simulated Use: Not explicitly stated.
• Shelf Life Testing: Not explicitly stated.
• Sterilization Testing: Not explicitly stated.
• Biocompatibility: Not explicitly stated for specific tests, but based on the Reference device.

Data Provenance: The studies were conducted by Stryker Neurovascular ("Stryker Neurovascular has demonstrated...") and are retrospective for most tests as they leverage previous device submissions (K172167 and K181354). The animal study, for instance, was also performed to support previously cleared devices.

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

Not applicable. This device is a physical medical catheter, and the evaluation involves engineering and performance testing, not analysis of medical images or data requiring expert interpretation for ground truth.

4. Adjudication Method:

Not applicable. See point 3.

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

No. This is a physical medical device (catheter), not an AI/ML system that would involve human readers.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is defined by compliance with established engineering design specifications, international standards (e.g., EN ISO 10993-1), and acceptable performance in simulated use models. For example:

• Particulate Characterization: Acceptable levels of particulates.
• Simulated Use: Meeting applicable user needs and design specifications in an in vitro neurovascular model.
• Shelf Life/Sterilization: Meeting established acceptance criteria for shelf life and achieving a specific sterility assurance level.
• Biocompatibility: Compliance with EN ISO 10993-1.

8. Sample Size for the Training Set:

Not applicable. 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:

Not applicable. See point 8.

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The Zenith Flex Aspiration System, including the 046 Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The InNeuroCo 046 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Nitinol to provide support. The proximal section has an embedded nitinol flat wire cross coil that transitions to a nitinol round wire sinqle coil in the distal end. It has a radiopaque Platinum/Iridium marker band on the distal end. The 046 Zenith Flex Catheter is available with an internal diameter of 0.046 inches. The outer diameter is 0.058 inches along the proximal shaft and 0.056 inches at the distal tip. The 046 Zenith Flex Catheter is available in two working lengths: 153 cm, and 160 cm. The 046 Zenith Flex Catheter has a PTFE-lined lumen to reduce friction as it travels over a guidewire. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and peel-away introducer. The 046 Zenith Flex Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The other system components are: the Aspiration Tubinq Set and the VC-701 Cliq Aspirator Pump. The Aspiration Tubing Set is provided sterile and is intended for single use only. The aspiration pump is provided non-sterile and is used in multiple procedures.

The provided document is a 510(k) premarket notification for a medical device, the Zenith Flex Aspiration System (046 Zenith Flex Catheter). It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Penumbra 3 Max) and a reference device (071 Zenith Flex System).

The document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers or the establishment of ground truth in the context of diagnostic AI. Instead, it details the physical and mechanical performance testing of a catheter and its accessories. Therefore, many of the requested details, such as those related to AI algorithm performance, ground truth, expert adjudication, or MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and performance information as presented for the physical device.

Here's a breakdown of the requested information based on the provided document:

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

The document provides a comprehensive table of non-clinical tests, their methods, acceptance criteria, and conclusions. Since the "performance" for all these tests is simply stated as having "met the acceptance criteria" or "passed," this table effectively serves as the performance report. I will summarize key categories, as a direct copy of the entire table would be extensive.

• Reactivity grade 0 and that enough samples were tested to demonstrate compliance.

• Data Provenance:
  • Non-Clinical (Bench) Testing: This was conducted by InNeuroCo, Inc. (location: Sunrise, Florida, USA). The testing was done in a controlled lab environment.
  • Animal Testing: Conducted in swine, implying a prospective study design for the animal component. The document does not specify the country of origin for the animal study, but given the company's US location and FDA submission, it's likely primarily US-based or conducted under equivalent regulatory standards.
  • Clinical Data (Literature Review): A review of "published clinical study articles" was conducted. This refers to existing, likely retrospective, clinical data from external sources and studies. No new clinical trials were performed for this submission.

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

• Not applicable. This document describes a physical medical device (catheter system) and its performance validation through bench and animal testing. It does not involve diagnostic imaging or AI for which ground truth established by experts would be relevant. The "ground truth" for this device's performance is objective measurements (e.g., dimensions, burst pressure, tensile strength, successful thrombi removal in models) and histopathological/angiographic assessments in animal models.
• A "physician" was involved in "simulated use testing," but this was for usability and performance in a benchtop model, not for establishing a diagnostic ground truth. Their qualifications are not specified beyond being a "physician."

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

• Not applicable. As an AI/ML related concept, adjudication by multiple experts is not relevant to the physical and mechanical testing of a catheter system.

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, not applicable. This document is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes.

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

• No, not applicable. This is not an AI/ML device.

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

• For non-clinical bench testing: The "ground truth" for acceptance was based on predefined physical, mechanical, and performance specifications (e.g., measurements being within specified ranges, successful functional outcomes like thrombi removal, absence of leaks or degradation).
• For animal testing: The "ground truth" for effectiveness and safety was based on angiographic assessment of revascularization and histopathological assessment.

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. As there is no AI/ML component, there is no training set or associated ground truth establishment process in that context.

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The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - MI and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The Stryker AXS Vecta Aspiration System includes an aspiration catheter and its accessories, including the Scout Introducer, the Peel-Away Introducers, the Hemostasis Valve, the AXS Universal Aspiration Tubing, the Medela Dominant Flex Pump, and the AXS Universal Liner Set.

This document is a 510(k) summary for the AXS Vecta Aspiration System, which is a percutaneous catheter used for revascularization in patients with acute ischemic stroke. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (K190212).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document provides a "Performance Testing Summary" table (Table 2) which includes the "Test" conducted and the "Conclusion". While it states "All units met the acceptance criteria and passed," the specific acceptance criteria values for each test are not explicitly listed in this document. The table implicitly states that the device met the unlisted criteria.

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

The document states, "All units met the acceptance criteria" or "All samples met acceptance criteria" for each test, implying that the acceptance criteria were met by all tested units/samples. However, the specific number of samples used for each non-clinical bench test is not explicitly mentioned.

No animal or clinical studies were performed for the current submission. The document states that animal testing previously conducted for the AXS Vecta Aspiration System was leveraged (from K190212, K172167, and K181354). The provenance of this leveraged animal data (country of origin, retrospective/prospective) is not specified in this 510(k) summary.

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 510(k) summary primarily relies on non-clinical bench testing. Therefore, there are no human experts establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for bench tests is defined by engineering specifications and test protocols.

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

Since no clinical or human-reader studies were conducted for this submission, an adjudication method for a test set is not applicable.

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

No MRMC comparative effectiveness study was done as this is a medical device (catheter) and not an AI-assisted diagnostic tool.

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

This refers to an algorithm's performance without human interaction. This is not applicable as the device is a physical catheter, not an algorithm.

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

For the non-clinical bench tests (e.g., tensile strength, burst pressure, dimensions), the ground truth is based on engineering specifications and established test methods that define what constitutes acceptable performance for a medical device of this type.

8. The sample size for the training set

This is not applicable as the device is a physical medical device (catheter) and not a machine learning or AI 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 above.

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