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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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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.

The acceptance criteria and study proving the device meets them are described in the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document repeatedly refers to "test samples" for each test. However, the exact number of samples used for "Simulated Use - Bench," "Simulated Use – Usability," "Vacuum Drop / Suction Connector Secure Attachment," and "Lumen Patency" tests is not explicitly stated.
• Data Provenance: The tests are described as "benchtop model" tests and "Animal testing previously conducted for the Zenith Flex System was used to support this change." This indicates:
  • Bench Tests: Performed in a laboratory setting.
  • Animal Testing: The previous animal testing for the predicate device (Zenith Flex System) was retrospectively leveraged. The original context of this animal testing (country of origin, etc.) is not detailed in this document.

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

• For "Simulated Use - Bench" and "Simulated Use – Usability," the testing was conducted "by a physician." The document specifies "a physician" (singular).
• Qualifications of the physician: Not explicitly stated beyond "physician."

4. Adjudication Method for the Test Set

• The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "Simulated Use" tests were conducted "by a physician," and the "test samples must meet predetermined user needs." It implies a direct assessment by the physician against predefined criteria rather than an adjudication process involving multiple reviewers of outcomes.

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

• No MRMC study was done. The document explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a medical aspiration system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study would not be relevant.

7. Type of Ground Truth Used

• Expert Assessment/Predicate Device Performance:
  • For the "Simulated Use" tests, the ground truth was effectively whether the "test samples met predetermined user needs" as assessed by a physician.
  • For the engineering tests (Vacuum Drop, Lumen Patency, Calculated Force at Tip), the ground truth was based on meeting "existing pressure specifications" or "existing lumen patency specifications," which are predefined technical performance standards, and comparison to the performance of the predicate device.
  • For the animal testing (leveraged from the predicate), the ground truth would have been safety and efficacy outcomes observed in the animal model.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

• Not applicable. As above, there is no training set for this type of device.

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