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The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.

The subject Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.

This document is a 510(k) Summary for a medical device called the "Neurovascular Access System Family." It details the device's characteristics, intended use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.

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

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

Biocompatibility Tests:

Sterility Testing:

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 lists "Performance Data" in Section VII and "Biocompatibility" in Section VIII.

• Performance Data: The specific sample sizes for each performance test (e.g., visual, dimensional, burst, fatigue) are not explicitly stated in this summary table. The document only indicates "Pass" for each test. The methods refer to ISO standards and FDA guidance documents, which typically define appropriate sample sizes for such tests.
• Biocompatibility Data: Similarly, the sample sizes for the various biocompatibility tests (e.g., number of cells, animals for in vivo tests) are not explicitly stated.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. These are typically bench and laboratory tests performed by the manufacturer or contract labs.

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)

• For the "Simulated Use and Usability" test, the objective states an "usability assessment with multiple physicians." The exact number of physicians and their specific qualifications are not provided in this summary.
• For all other tests, ground truth is established by objective measurements against specified standards (ISO, ASTM, FDA guidance), rather than expert consensus on images or outcomes. Therefore, "experts" in the sense of clinical reviewers establishing ground truth for diagnostic accuracy are not applicable here.

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

Not applicable. This device is an access catheter, and the performance criteria are based on engineering, mechanical, and biological testing, not on interpretation of clinical data requiring adjudication by experts.

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 (catheter), not an AI diagnostic algorithm. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant to this submission.

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

Not applicable. This is a medical device (catheter), not an algorithm or AI system.

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

The ground truth for this device's performance testing is based on:

• Established Industry Standards: ISO 10555-1, ISO 10993 series, ASTM standards.
• FDA Guidance Documents: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions."
• Objective Measurements: Such as dimensional measurements, pressure thresholds, tensile strength, flow rates, visual inspection for corrosion or particulates, and biological responses in biocompatibility tests.
• Simulated Use: Involving usability assessment (implied to be clinical feedback from physicians during simulated use).

Essentially, the ground truth is adherence to predefined physical, chemical, mechanical, and biological specifications and performance metrics.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model that requires training data.

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

Not applicable. There is no training set for this type of medical device submission.

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072 Aspiration Catheter: As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated for use 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 therapy are candidates for treatment.

Aspiration Tubing: As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump.

The 072 Aspiration Catheter is a single lumen, variable stiffness catheter. The catheter has a hydrophilic coating to reduce friction during use. The catheter includes radiopaque markers on the distal end for angiographic visualization and a Luer hub on the proximal end allowing attachments for flushing and aspiration. The Delivery Tool is an optional accessory for use with the 072 Aspiration Catheter and should be removed prior to aspiration. The 072 Aspiration Catheter, Delivery Tool. Rotating Hemostasis Valve, and Flow Switch are included in the package. The Aspiration Tubing is provided in a separate package. For the aspiration source, the 072 Aspiration Catheter is used in conjunction with a compatible suction pump with prespecified performance parameters that is connected using the Aspiration Tubing.

Here's a breakdown of the acceptance criteria and study information for the Q'Apel Medical, Inc. 072 Aspiration System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally phrased as meeting "predetermined acceptance criteria" or specific ISO standards. The reported device performance for all bench tests and animal studies is "Pass," indicating that all samples met the defined criteria.

Note: For bench tests, specific numerical acceptance criteria are not detailed in the provided summary, only the general statement that "All samples met the predetermined acceptance criteria." For biocompatibility, the specific numerical acceptance criteria are listed.

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

• Bench Testing: The document consistently states "All samples met the predetermined acceptance criteria" for each bench test. However, the exact numerical sample size for each specific bench test is not provided.
• Animal Study: The study involved a "porcine model." The exact number of animals used is not specified. The study was conducted "according to Good Laboratory Practices (GLP) per 21 CFR Part 58," which indicates controlled experimental conditions.
• Data Provenance:
  • Bench Testing: In-house testing by Q'Apel Medical, Inc.
  • Animal Study: Experimental, prospective study in a porcine (animal) model.

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

• Bench Testing: Not applicable in the context of expert ground truth. These tests likely involved technicians or engineers following standardized protocols.
• Animal Study: The document doesn't specify the number or qualifications of experts (e.g., veterinarians, pathologists) involved in establishing ground truth (e.g., assessing vessel histology or clot aspiration results). It mentions that "Sub-chronic and chronic time points were assessed" and that "Clot aspiration and wedge assessment were comparable between the test and control catheters, and both were shown to be safe in porcine vessels via angiography and vessel histology." This implies expert assessment of the outcomes, but details are absent.

4. Adjudication Method for the Test Set

• Bench Testing: Not applicable. Bench tests typically rely on objective measurements against predefined specifications.
• Animal Study: Not specified. While the results were declared "comparable" and "safe," it's not explicitly stated if multiple experts reviewed the outcomes and how any discrepancies were resolved.

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 done. The document explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes and to support the substantial equivalence of the 072 Aspiration System." Therefore, there is no effect size reported for human readers with and without AI assistance.

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

• Not applicable. The device is a physical medical instrument (an aspiration catheter system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance reviewed is the device's physical function.

7. The Type of Ground Truth Used

• Bench Testing: Reference standards (e.g., ISO standards), design specifications, and comparison to a reference device (K211564 for simulated use particulates) were used to establish "ground truth" (i.e., expected performance).
• Animal Study: Angiography and vessel histology were used as ground truth for assessing safety and effectiveness (clot aspiration, wedge assessment, tissue response) in the porcine model. These are objective measures collected during and after the animal procedures.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical instrument, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used to train an AI model.

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

• Not applicable. As stated above, this is not an AI device, so there is no training set or ground truth for a training set.

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The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The subject SelectFlex Neurovascular Access System Family is a line extension to expand the previously cleared device (K211893) by offering a new SelectFlex III 064 Neurovascular Access Catheter with a diameter of 6F, a 6F dilator, an introducer sheath, and a 4.5F Access Tool that can be used with the catheter to access the desired anatomy. The 4.5F Access Tool is an accessory provided with the SelectFlex III 064 Neurovascular Access Catheter and is packaged in the same sterile pouch with the SelectFlex III 064 Neurovascular Access Catheter and accessories as part of the SelectFlex Neurovascular Access System Family.

The provided text is a 510(k) Summary for a medical device (SelectFlex Neurovascular Access System Family) and does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop diagnostic system. Instead, it describes nonclinical performance testing (bench testing) and biocompatibility testing conducted to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested items (e.g., sample sized for the test set in an AI study, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract the acceptance criteria (goals) and reported performance (results) from the nonclinical performance data section.

Here's the information based on the provided text:

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

For the SelectFlex Neurovascular Access System Family (including the SelectFlex III 064 Neurovascular Access Catheter, 6F Dilator, and 4.5F Access Tool where applicable):

Biocompatibility Testing:

2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for each particular test, only stating "All samples" or providing a conclusion based on the samples tested. The data provenance is "bench testing" and "biocompatibility testing," which are laboratory-based tests of the device itself, not clinical data or data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device performance and biocompatibility study, not an AI diagnostic study relying on expert ground truth. However, for "Simulated Use/Usability," it states "usability assessment with multiple physicians," but specific numbers or qualifications are not provided.

4. Adjudication method for the test set
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
Not applicable. No AI component is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No AI component is mentioned.

7. The type of ground truth used
For nonclinical performance, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 10555-1, FDA guidance documents, ASTM D4332, AAMI TIR42, ISO 10993 series for biocompatibility). The device's physical properties and interactions are measured against these objective criteria.

8. The sample size for the training set
Not applicable. There is no AI training set as this is a device performance study.

9. How the ground truth for the training set was established
Not applicable. There is no AI training set.

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