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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:

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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.

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

The SelectFlex Neurovascular Access System Family consists of sterile, single-use intravascular catheters used to facilitate access to target vasculature during interventional procedures. The system is composed of a SelectFlex Neurovascular Access Catheter, a 3cc Mode Control Syringe, a 7Fr Peel Away Introducer, Luer Activated Valve and a Dilator (only for versions with a Long Hydrophilic coating to ease dermal entry). The SelectFlex Neurovascular Access Catheter comes in usable lengths of 95, 105 or 115cm. The SelectFlex Neurovascular Access Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex Neurovascular Access Catheter comes in two options of a short hydrophilic coating length of 11.5cm or a long hydrophilic coating length of 30cm.

The provided FDA 510(k) summary for the SelectFlex Neurovascular Access System Family describes non-clinical performance data (bench testing) to demonstrate substantial equivalence to a predicate device, rather than a study involving human subjects or AI performance metrics. Therefore, many of the requested elements pertaining to AI studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted and a clear indication where the requested information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All samples met the pre-determined acceptance criteria" for each test, implying that the acceptance criteria were defined prior to testing, but the specific quantitative or qualitative criteria for each test (e.g., maximum allowable particulate count, specific tensile strength values, specific pass/fail conditions for visual inspection) are not explicitly detailed in this summary.

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

The document does not specify the exact sample size for each bench test beyond "All samples." It states "Simulated use testing includes a usability assessment with multiple physicians" but does not give a number for the physicians or the number of simulated cases.

Data Provenance: The data is from non-clinical bench testing and simulated use conditions, not from human clinical data or retrospective/prospective studies on patient data.

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

Not applicable. This is not an AI performance study requiring ground truth established by experts. For the "Simulated Use/Usability" test, it mentions "multiple physicians," but their specific number or qualifications are not provided as they are assessing usability, not establishing ground truth on patient data.

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

Not applicable. This is not an AI performance study requiring adjudication of expert readings.

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. This document describes the substantial equivalence of a physical medical device (catheter system) based on bench testing, not an AI software.

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

Not applicable. This document does not describe an AI algorithm.

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

Not applicable. For the non-clinical bench tests, "ground truth" would be objective measurements against engineering specifications and industry standards (e.g., ISO 10555-1: 2013, ISO 80369-7) rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document does not describe an AI system that requires a training set.

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

Not applicable. This document does not describe an AI system.

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