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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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The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.

The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:

• . 087 Balloon Guide Catheter
• 1cc Inflation Syringe ●
• 8Fr Peel Away Introducer ●
• Hub Extension
• Three Way Stopcock ●
  The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.

The provided document is a 510(k) Premarket Notification from the FDA for the 087 Balloon Guide Catheter System. This document outlines the regulatory review of a medical device, focusing on demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on your request:

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

The document presents a "Nonclinical Performance Testing Summary" which serves as the primary evidence for meeting acceptance criteria. Each "Study Name" implicitly defines an acceptance criterion (e.g., "Conditioning, Distribution, and Shelf Life Aging Verification" implies a criterion for packaging strength and integrity). The reported device performance for all tests is simply "Pass" with the statement "All samples met the pre-determined acceptance criteria."

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

The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence." The entire submission relies on non-clinical performance bench test data.

• Sample Size: The document does not specify the numerical sample size for any of the individual bench tests. It consistently reports "All samples met the pre-determined acceptance criteria," implying that a specific sample size was tested for each criterion, but the exact number is not provided.
• Data Provenance: The data is from non-clinical bench testing. There is no information about the country of origin of the data as these are laboratory tests. It is inherently retrospective in the sense that the testing was performed and then reported for this submission.

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

This information is not applicable to this submission. The "ground truth" for the non-clinical performance bench tests is established by technical standards and pre-determined acceptance criteria (e.g., ASTM, ISO standards, or internal specifications). There's no indication that human experts were used to establish ground truth for these device performance metrics.

4. Adjudication method for the test set

This is not applicable. Since the ground truth for the bench tests is based on objective measurements against pre-defined numerical or qualitative criteria (e.g., "Pass/Fail" based on whether a specification is met), there is no need for expert 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

There was no MRMC comparative effectiveness study done. This device is a physical medical instrument (catheter), not an AI/software device that assists human readers with interpretation. Therefore, questions regarding AI assistance and effect size are not relevant here.

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

This is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI.

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

The ground truth for the non-clinical performance bench tests is based on established engineering and material science standards (e.g., ISO and ASTM standards) and pre-determined internal acceptance criteria. For example:

• ASTM F88 for Seal Strength
• ASTM F2096 for Detecting Gross Leaks
• ISO 10555-1 for General requirements of intravascular catheters
• ISO 10555-4 for Balloon Dilatation Catheters
• ISO 80369-7 for Small-bore connectors
• AAMI TIR42 and **USP ** for particulates
• DIN EN 13868 for kink resistance
• FDA CTQ: Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices, August 2015 (for particulates)

These standards define the methodologies and acceptable limits for various physical and functional characteristics of catheters.

8. The sample size for the training set

This is not applicable. The device is a physical catheter, not a machine learning model. Therefore, there is no "training set."

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

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

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The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access to target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, a 7Fr Peel Away Introducer, and Hub Extension Line. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 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 072 Catheter has a hydrophilic coating.

The provided document is a 510(k) summary for the SelectFlex 072 Neurovascular Access System, asserting its substantial equivalence to a predicate device (SelectFlex 072 Neurovascular Access System K181000). The summary focuses on comparing the new device to the predicate and presenting nonclinical bench test data. It does not detail a study proving the device meets acceptance criteria for an AI/ML-based medical device. The documentation pertains to a traditional medical device (a catheter system), not an AI-enabled device.

Therefore, the following information cannot be extracted from the provided text for an AI/ML-based device:

• A table of acceptance criteria and the reported device performance: The document lists bench tests and states "PASS" for all, meaning all samples met "pre-determined acceptance criteria," but it does not specify the numerical or qualitative acceptance criteria for each test in a detailed table that would be typical for an AI/ML performance summary (e.g., sensitivity, specificity, AUC thresholds). The acceptance criteria for the new device are implicitly that they perform equivalently to the predicate device in the listed bench tests.
• Sample size used for the test set and the data provenance: No information on test set sample size or data provenance in the context of an AI/ML study is provided. The bench tests would have their own sample sizes, but these are not for an AI model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML study requiring expert-derived ground truth.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, based on the document, I can provide information relevant to a traditional medical device's nonclinical performance evaluation:

1. Table of Acceptance Criteria and Reported Device Performance (Nonclinical Bench Testing):

The document states that all tests resulted in "PASS," meaning all samples met "pre-determined acceptance criteria." The specific numerical acceptance criteria themselves are not listed in this summary, only the outcome.

2. Sample sized used for the test set and the data provenance:

The document mentions "All samples met the pre-determined acceptance criteria" for various bench tests, but does not specify the sample size (n) for each test set used in the nonclinical bench testing. Data provenance is not applicable in the context of clinical data for an AI/ML device, as these are bench tests.

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

For the "Simulated Use/Usability" test, the document states it "includes a usability assessment with multiple physicians." The specific number and qualifications of these physicians are not provided. This is not establishing "ground truth" in an AI/ML context, but rather assessing usability.

4. Adjudication method for the test set:

Not applicable in the context of bench testing for a traditional medical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, this type of study was not conducted as this is a non-AI/ML device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used:

Not applicable, as this is not an AI/ML device. For the bench tests, the "ground truth" is defined by established international and national standards (e.g., ISO, ASTM, USP) and the device's own specifications.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device.

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The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.

The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:

• 087 Balloon Guide Catheter
• 1cc Inflation Syringe
• 8Fr Peel Away Introducer
• Hub Extension
• Three Way Stopcock

The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Neurovascular Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.

The provided document is a 510(k) Premarket Notification summary for the Q'Apel Medical LLC 087 Balloon Guide Catheter System. It describes the device, its indications for use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The entire submission focuses on demonstrating the substantial equivalence of a new medical device (a catheter system) to an already legally marketed predicate device, rather than proving the efficacy of a new AI/software-based medical device. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth adjudication, and training set details are not applicable to this document. The "studies" here are primarily benchtop and biocompatibility tests on a physical medical device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Pass" indicating that "All samples met the pre-determined acceptance criteria" for each listed test. The reported performance is a statement of compliance with these criteria.

Biocompatibility Testing Summary:

Study Details (Applicability to a Physical Medical Device, Not AI/Software)

1. Sample sizes used for the test set and the data provenance:

   • The document states "All samples met the pre-determined acceptance criteria" for each test. However, the specific number of samples tested for each benchtop performance or biocompatibility test is not explicitly provided in the summary.
   • Data provenance: These are laboratory/benchtop tests and in vitro biocompatibility tests, not data derived from patients or clinical sources. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable. The tests are conducted in a controlled lab environment.

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

   • Not applicable. For a physical device like a catheter, "ground truth" is established by adherence to engineering specifications and international standards (e.g., ISO, ASTM) through objective physical testing, not by expert consensus on interpretations of data.
   • Experts, if involved, would be internal engineers, quality control personnel, or third-party testing labs specializing in medical device testing, not typically medical experts like radiologists establishing diagnostic "ground truth."

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading, clinical diagnoses) where multiple experts might disagree. These are objective engineering and biological tests with defined pass/fail criteria.

4. 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, an MRMC study was not done. This type of study is specifically for evaluating the impact of AI algorithms on human performance in diagnostic tasks (e.g., radiology). This submission is for a physical catheter, not an AI software. The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."

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

   • Not applicable. This relates to the performance of an AI algorithm alone. The device is a physical catheter system, not a software algorithm.

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

   • Ground truth for this device is based on engineering specifications, physical measurements, and adherence to established international standards (e.g., ISO 10555-1, ASTM F88, ISO 10993 series). It's objective, quantitative data from benchtop and in vitro (laboratory) tests.

7. The sample size for the training set:

   • Not applicable. This concept pertains to machine learning models (AI). There is no "training set" for a physical medical device. The device itself is manufactured to specifications.

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

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

In summary, the provided document details the testing and acceptance criteria for a physical medical device (a catheter system) to demonstrate its substantial equivalence to a predicate device for FDA 510(k) clearance. It does not involve AI or software, and therefore, many of the questions related to AI validation methodologies (e.g., MRMC studies, expert adjudication, training/test sets) are not relevant to this specific submission.

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The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, and a 7Fr Peel Away Introducer. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 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 072 Catheter has a hydrophilic coating.

This document, a 510(k) summary for the SelectFlex 072 Neurovascular Access System, describes various performance tests conducted to demonstrate the device's suitability for its intended use, rather than a clinical study evaluating an AI algorithm's performance.

Therefore, many of the requested fields regarding AI algorithm evaluation are not applicable (N/A) in this context. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological performance testing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test in a table, but rather indicates that all samples "met the pre-determined acceptance criteria" or "passed" the tests. The acceptance criteria are implicitly defined by the referenced ISO/ASTM standards and internal product specifications.

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 does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flex fatigue). It generally states "All samples met the pre-determined acceptance criteria," implying that a sufficient number of samples were tested per the relevant standards.

• Sample Size for Test Set: Not explicitly stated for each test, but implied to be adequate for standard compliance.
• Data Provenance: Not specified. This typically refers to data like patient images or clinical records, which are not relevant to these engineering and biocompatibility tests. The tests themselves are laboratory-based.

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

• Number of Experts: For the "Simulated Use/Usability" test, it states "a usability assessment with multiple physicians." The exact number or qualifications are not provided beyond "physicians."
• Qualifications of Experts: "Multiple physicians" for usability assessment. For other tests, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and internal product specifications, carried out by qualified testing personnel, but not "experts" in the sense of clinical specialists interpreting results.

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

Not applicable. This is not a clinical study involving interpretation of data by multiple readers. The assessment of performance tests is based on objective measurements against pre-defined criteria in laboratory settings.

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 document pertains to the performance and safety testing of a neurovascular access system, not an AI or imaging diagnostic device. No AI component is mentioned.

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

Not applicable. This is not an AI algorithm.

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

For the performance and biocompatibility tests, the "ground truth" is established by:

• Compliance with international standards: ISO, ASTM, AAMI, USP.
• Adherence to internal product specifications: Dimensional verification.
• Comparison to predicate/reference devices: For tip deflection, flow rate, and device removal forces.
• Usability assessment: By "multiple physicians" in a simulated environment.

No pathology or outcomes data are referenced as this is a pre-market notification for a device and not a clinical trial.

8. The sample size for the training set

Not applicable. This is not an AI algorithm, so there is no training set.

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

Not applicable. There is no AI training set.

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