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The Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

The Q Distal Access Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The proximal portion of the device is a stainless-steel control wire. The distal portion of the device is a coiled/braided catheter shaft with hydrophilic coating along the entire length to reduce friction during use. The Q Distal Access Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The pin vise may be used to advance the catheter. The syringe and flush tool components may aid in the flushing of the Q Distal Access Catheter.

The medical device described, the Q Distal Access Catheter, is not an AI/ML powered device, therefore, the requested information regarding AI/ML related aspects (such as effect size, standalone performance, training set details, and expert qualifications for ground truth) is not applicable. The provided text details the non-clinical performance testing for a physical medical catheter.

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Q Distal Access Catheter are derived from various non-clinical performance tests, including bench testing and biocompatibility testing. The "Results" column from the provided tables serves as the reported device performance, indicating that the device "Pass"ed each criterion.

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

The document does not explicitly state the sample sizes used for each specific bench or biocompatibility test. The evaluation involved "design verification testing" and "additional biocompatibility testing." The provenance of the data is from internal testing conducted by MIVI Neuroscience, Inc., as part of their 510(k) submission. This is considered retrospective for the purpose of the submission, as the tests were performed to demonstrate compliance of an already designed and manufactured device.

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

This question is not applicable as the Q Distal Access Catheter is a physical medical device, not an AI/ML powered device that relies on expert interpretation for "ground truth" establishment in its performance evaluation. The "ground truth" in this context refers to established engineering specifications, material science standards, and biocompatibility guidelines.

4. Adjudication Method for the Test Set

This question is not applicable for a physical medical device. The "adjudication method" concept is typically used for subjective assessments in clinical or AI/ML studies where human interpretation of ambiguous data is involved. For engineering and scientific testing of a physical device, results are typically objective and determined by established protocols and measurement techniques.

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

This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve AI assistance for human readers.

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

This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not have a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Q Distal Access Catheter's performance evaluation is based on a combination of:

• Design Specifications: Predefined engineering requirements and dimensional tolerances for the catheter.
• Established Industry Standards: Such as ISO 11135:2014 for sterilization, ISO 10993-7 for biocompatibility residuals, ASTM F756 for hemolysis, and USP 24 chapter 85 for bacterial endotoxins.
• Visual and Mechanical Inspection Criteria: Standardized methods to assess physical integrity, coating uniformity, and functional performance.
• Physiological Response Criteria: For biocompatibility, established thresholds for cytotoxicity and hemolysis.

8. The Sample Size for the Training Set

This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.

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

This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.

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The MIVI Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

The MIVI Q Distal Access Catheter (Q Catheter) is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MIVI Q Distal Access Catheter:

The document provided is a 510(k) Summary for the MIVI Q Distal Access Catheter, which is a premarket notification to the FDA for a medical device seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than proving novel effectiveness.

Given the nature of a 510(k) submission for a catheter, the "acceptance criteria" and "device performance" in this context refer to the ability of the device to meet specified engineering and biocompatibility standards, and to perform its intended function without significant differences from the predicate. There is no clinical study in the traditional sense (e.g., patient trials with efficacy endpoints) described for this device, as it's a substantially equivalent determination based on non-clinical testing.

Here's the information extracted and organized according to your request:

Acceptance Criteria and Device Performance for MIVI Q Distal Access Catheter

1. Table of Acceptance Criteria and Reported Device Performance

For Bench Testing (Non-Clinical Performance):

For Biocompatibility Testing:

For Sterilization and Shelf Life:

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

The document does not specify the exact sample sizes used for each individual non-clinical (bench and biocompatibility) test. Such details are typically found in the full test reports, not in the summary document.

Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting (in vitro or in animal models), not on human subjects. Therefore, there is no country of origin for human patient data. The provenance of the data is the laboratory where the tests were performed. The studies are prospective in the sense that they were designed and executed to test the characteristics of the MIVI Q Distal Access Catheter.

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

This question is not applicable to the provided document. The "ground truth" in this context is established by objective measurements and standardized test methods (e.g., ISO standards for biocompatibility, engineering specifications for bench tests), not by expert consensus on clinical data. No human "experts" were used to establish ground truth for this type of non-clinical testing.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for interpreting imaging or clinical outcomes where there might be inter-reader variability. For non-clinical bench and biocompatibility tests, results are typically objective (e.g., a tensile strength value, a cytotoxicity rating) and do not require expert adjudication in this manner.

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

This is not applicable. The MIVI Q Distal Access Catheter is a physical medical device (a catheter), not an AI algorithm, and therefore does not involve human readers interpreting output from an AI system. The submission is for substantial equivalence of a physical device.

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

This is not applicable. As explained above, this device is a physical catheter, not an AI algorithm.

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

For the non-clinical tests described:

• Bench Testing: Ground truth is defined by engineering specifications and objective physical measurements (e.g., specified dimensions, force thresholds, pressure integrity).
• Biocompatibility Testing: Ground truth is established by standardized biological assays and observation in animal models and in vitro systems, as per recognized international standards (e.g., ISO 10993 series). The results are objective measurements against defined pass/fail criteria.

8. The sample size for the training set

This is not applicable. There is no AI algorithm involved that requires a training set. The "study" here consists of non-clinical performance and biocompatibility testing of the physical catheter.

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

This is not applicable, as there is no AI algorithm or training set.

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The MIVI Mi-EXT Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Not Found

There is no information in the provided text about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) clearance letter for the MIVI Mi-EXT Catheter, indicating it has been found substantially equivalent to a predicate device. It specifies the intended use of the catheter but does not detail performance metrics, study design, or any of the other requested information.

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The MIVI Mi-Axus™ Guide Catheter is indicated for use in facilitating the insection and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

The MIVI Mi-Axus 8F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary, or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. Additionally, the distal segment of the PEBAX shaft of the 8F device is impregnated with Barium Sulfate (BaS04) for increased radiopacity. A luer hub on the proximal end allows attachments for flushing, insertion of catheters, and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MIVI Mi-Axus Guide Catheter has a straight distal tip and is available in lengths of 80 or 90 cm and an 8F diameter.

The provided text describes a 510(k) summary for the MIVI Mi-Axus™ Guide Catheter. It does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML medical device. Instead, it details the functional, biocompatibility, and sterilization testing performed for a guide catheter.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence for a medical device (a guide catheter) based on its physical properties, materials, intended use, and comparison to predicate devices, rather than on the performance metrics of an AI/ML algorithm.

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The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.

The Viradius™ Neurowire consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The distal section of the guidewire is coated with a hydrophilic coating and the proximal portion of the device is coated with a hydrophobic coating. The guidewire is inserted into a polyethylene hoop and then placed along with a torque device into a labeled poly/tyvek pouch and ethylene oxide sterilized. The pouch, along with an Instruction for Use paper insert is placed into a labeled shipping box.

The Viradius™ Neurowire is a guidewire intended for selective placement of catheters within the neuro and peripheral vasculature. The information provided outlines the acceptance criteria and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device (NeuroScout Steerable Guidewire, K100351).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Viradius™ Neurowire are generally that the device "meets acceptance criteria" or performs comparably to the predicate device or selected competitor guidewires, or that the results are adequate/acceptable. The reported device performance indicates that all devices met these criteria for all tested parameters.

2. Sample Size and Data Provenance (Test Set)

The document does not explicitly state the sample sizes (number of units or iterations) used for each specific bench test mentioned. However, for all performance tests, it states that "All devices met acceptance criteria." This implies that a sufficient number of devices were tested to draw this conclusion based on the test methods used.

The data provenance for the test set is retrospective/bench (laboratory) data, generated from direct testing of the Viradius™ Neurowire and comparison to the predicate device or competitor guidewires. There is no indication of country of origin as it applies to clinical data, as no clinical studies were performed.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

This section is not applicable. The studies described are primarily bench (laboratory) performance tests and biocompatibility testing, not studies that involve human interpretation of medical images or diagnoses requiring expert ground truth in the traditional sense. The "ground truth" for these tests is the objective physical and chemical properties and performance of the device relative to established standards or a predicate device.

4. Adjudication Method (Test Set)

This section is not applicable. As the studies were bench tests demonstrating physical performance and material safety, there was no adjudication method involving multiple human reviewers to establish a consensus or resolve discrepancies, which is typical for clinical or imaging studies.

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

No MRMC comparative effectiveness study was performed. The submission explicitly states: "No clinical studies were performed as there are no change to the indications for use or the fundamental scientific technology of the device." Therefore, there is no information on the effect size of human readers improving with or without AI assistance. This device is a medical instrument, not an AI or imaging diagnostic tool.

6. Standalone (Algorithm Only) Performance

No standalone performance study was done. This device is a medical guidewire, a physical instrument, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this submission.

7. Type of Ground Truth Used

The "ground truth" for the performance testing was based on:

• Engineering/Performance Standards: Adherence to established ISO standards (e.g., ISO 11070:2014, ISO 11135-1:2007) and internal company specifications.
• Comparison to Predicate Device: Performance (e.g., torque response, push track force) comparable to the NeuroScout Steerable Guidewire (K100351).
• Objective Laboratory Measurements: Direct measurements of physical dimensions (diameter, length), visual inspection (surface integrity, corrosion), and chemical tests (biocompatibility).
• Simulated Use Models: Performance in simulated anatomical models (e.g., push track test, particulate testing in tortuous model).

8. Sample Size for the Training Set

No training set was used. This device is a physical medical instrument, not a machine learning model or AI algorithm that requires a training set.

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

Not applicable, as no training set was used.

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