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The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Esperance® Distal Access Catheter is a single-use, single lumen, variable stiffness, composite catheter. The device includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, and 131 cm. The device is supplied with a peelable introducer and shaping mandrel. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The Esperance® Distal Access Catheter is a non-active, surgically invasive device intended for short term use within the vasculature.

The provided document is a 510(k) Substantial Equivalence Determination letter from the FDA for a medical device called the "Esperance Distal Access Catheter." It details non-clinical performance testing but does not include information about a study proving device performance against acceptance criteria in the context of an AI/ML-driven device or human-in-the-loop performance.

Specifically, the document states:

• "Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."
• "A clinical study was not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."

Therefore, I cannot extract the requested information points related to a study proving the device meets acceptance criteria for an AI/ML device, as such a study was not performed or detailed in this submission. The tests listed are primarily engineering bench tests for a physical catheter, not AI model validation.

However, I can extract the acceptance criteria for the physical device's performance from the "NON-CLINICAL PERFORMANCE DATA" section.

Here's what I can provide based on the document:

1. A table of acceptance criteria and the reported device performance (for non-clinical bench tests):

For the remaining points, the document explicitly states that clinical or animal studies were not deemed necessary beyond the non-clinical bench testing for this specific device (a physical catheter). Therefore, the following information cannot be provided from the given text:

2. Sample sized used for the test set and the data provenance: Not applicable for an AI/ML context, as no such test set was described. Bench tests were performed on physical units, but specific sample sizes for each test are not listed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant to this physical device's non-clinical bench testing. "Physician Validation" was mentioned, but no details on the number or qualifications of physicians, nor their role in establishing a ground truth for an AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/ML system. Ground truth in this context would refer to the reference standards for the physical tests (e.g., precise measurements, material specifications, functional performance during simulated use).
8. The sample size for the training set: Not applicable, as there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.

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The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The Distal Access Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Distal Access Catheter has a radiopaque marker on the distal tip that is visible under fluoroscopy. The Distal Access Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has a straight tip. The catheter is offered in various lengths to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

The provided text describes information for a Distal Access Catheter, specifically related to its 510(k) premarket notification for FDA clearance. It details the device's characteristics, intended use, and comparisons to a predicate device, along with non-clinical performance testing (bench testing, biocompatibility, sterility, and shelf-life).

However, the prompt asks for acceptance criteria and a study that proves a device meets acceptance criteria, with specific questions related to AI/Machine Learning (ML) performance, such as:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done and its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The provided FDA 510(k) document is for a physical medical device (catheter) and does NOT describe any AI/ML components or studies. Therefore, it does not contain the information necessary to answer the questions about AI/ML acceptance criteria, test sets, ground truth establishment, or clinical studies involving AI.

Based on the provided document, here is a summary of acceptance criteria and performance for the physical device:

Acceptance Criteria and Device Performance (for the physical catheter)

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

The document lists various non-clinical (bench) tests and biocompatibility tests. The "Result" column effectively indicates whether the device met the pre-defined acceptance criteria for each test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document describes bench testing and biocompatibility testing only. It does not mention any clinical data, patient data, retrospective, or prospective studies.
• The sample sizes for these tests are not explicitly stated in numerical values (e.g., "n=X units were tested"), but implied by "test articles," "devices," or descriptions like "all bonding points."

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 question is irrelevant for the provided document as it concerns a physical catheter, not an AI/ML product requiring "ground truth" from experts interpreting medical images or data. The "ground truth" for this device's performance is established by objective engineering and biocompatibility test standards and measurements.

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

• This question is irrelevant for the provided document as it concerns a physical catheter, not an AI/ML product requiring clinical adjudication of interpretations.

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 or any clinical effectiveness studies were performed or described. The document explicitly states: "No clinical studies were deemed necessary to demonstrate substantial equivalence."

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

• Not applicable. This is a physical device, not an algorithm.

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

• For the physical device, the "ground truth" is defined by established engineering standards (e.g., ISO standards), physical measurements, chemical analyses, and biological assays. It's not based on expert clinical consensus or pathology in the context of diagnostic interpretation.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML product that undergoes "training."

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

• Not applicable. This is a physical device, not an AI/ML product.

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The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.

This document is a 510(k) summary for a medical device called the "Distal Access Catheter." It describes non-clinical performance testing and biocompatibility testing conducted to demonstrate that the device is substantially equivalent to a predicate device.

1. Table of acceptance criteria and the reported device performance:

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

The document describes non-clinical (bench and in vitro) and biocompatibility testing. It does not mention a "test set" in the context of patient data or clinical images. Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable here.

For the non-clinical and biocompatibility tests, the sample sizes are not explicitly stated for each individual test. The document generally states "test sample" or refers to the number of cycles/animals without specifying the exact number for statistical power. The tests are performed on the device itself or its extracted components, not 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 a submission for a physical medical device (catheter) based on non-clinical and biocompatibility testing, not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis.

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

Not applicable. As noted above, there is no "test set" in the context of clinical data 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:

Not applicable. This is not an AI/software device, so MRMC studies are not relevant.

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

Not applicable. This is not an AI/software device. The performance reviewed here is the physical device's standalone performance under various bench and in vitro conditions.

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

The "ground truth" for the non-clinical and biocompatibility tests are defined by the established industry standards and test methods (e.g., ISO 10555-1:2013, ISO 10993 series, ASTM F640-12). The acceptance criteria outlined within these standards serve as the "truth" against which the device's performance is measured. For example, for cytotoxicity, the ground truth is "Viability > 70%."

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/software device.

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

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

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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 Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.

The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively.

A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.

The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.

A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter.

The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.

This document describes the regulatory clearance for a medical device called a "Distal Access Catheter," not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert ground truth, MRMC studies, and human-in-the-loop performance, are not applicable.

The acceptance criteria and the study that proves the device meets them are based on bench testing (physical and mechanical properties) and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device met its acceptance criteria through a series of bench tests and biocompatibility evaluations.

Bench Test Study:

• Study Design: The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. This standard specifies requirements for sterile, single-use intravascular catheters. The tests covered various physical and mechanical properties crucial for safe and effective device function.
• Methodology: The document lists 24 distinct bench tests (e.g., Surface Inspection, Dimensional Verification, Corrosion Resistance, Peak Tensile Force, Fluid Leakage, Kink Resistance, Simulated Use, Dynamic Burst, Flow Rate, etc.). Each test had specific acceptance criteria derived from the ISO standard or established engineering specifications for the device. The results consistently concluded that the device was "suitable for intended clinical use," "met requirements," or was "equivalent to the predicate device."
• Conclusion: The bench testing demonstrated that "the in vitro behavior of the device is well characterized within design specifications."

Biocompatibility Study:

• Study Design: The biocompatibility evaluation was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
• Methodology: The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58. These tests included Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolytic Properties, Partial Thromboplastin Time (PTT), In Vivo Thrombogenicity, Pyrogen, and Complement Activity tests. Each test had specific criteria for acceptable biological response. The conclusions for these tests consistently indicated that the device was non-cytotoxic, non-sensitizing, non-irritant, non-systemically toxic, had no effect on hemolytic properties or PTT, was equivalent to control/predicate for thrombogenicity and complement activity, and was non-pyrogenic.
• Conclusion: The biocompatibility testing confirmed the device material safety for its intended biological contact.

The following information is not applicable (N/A) as this is a traditional medical device (catheter) and not an AI/ML powered device.

2. Sample size used for the test set and the data provenance: N/A (for AI/ML test sets). These are physical and biological tests, not data-driven evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (for AI/ML expert annotation). Ground truth for physical/biological tests is based on objective measurements against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (for AI/ML 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: N/A (not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI algorithm).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" or acceptance standard is derived from established international medical device standards (e.g., ISO 10555-1, ISO 80369-7, ISO 10993 series, USP ) and internal design specifications, verified through objective bench and biological testing.
8. The sample size for the training set: N/A (not an AI/ML device; no training set in this context).
9. How the ground truth for the training set was established: N/A (not an AI/ML device).

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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 Q 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 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 catheter contains a pin vise threaded on the control wire, which may be used to advance the catheter.

Acceptance Criteria and Study for MIVI Q Distal Access Catheter

This document describes the acceptance criteria and study proving the MIVI Q Distal Access Catheter meets these criteria, based on the provided FDA 510(k) summary (K192558).

It's important to note that this device is a medical catheter and not an AI/ML powered device, so many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, data provenance) are not directly applicable in the context of this traditional medical device submission. The study focuses on bench testing (non-clinical performance testing) to demonstrate substantial equivalence to a predicate device, rather than clinical trials or AI model validation.

1. Table of Acceptance Criteria and Reported Device Performance

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

1. Sample Size: Not explicitly stated for each test. For medical devices undergoing bench testing, samples are typically chosen based on statistical methods to ensure representativeness and confidence in the results, though the exact numbers are not detailed in this summary.
2. Data Provenance: This is bench testing conducted by the manufacturer, MIVI Neuroscience, Inc., at their facilities. It is inherently prospective for the specific design verification of the modified device. Country of origin for the data is implicitly the United States, given the company's location (Eden Prairie, Minnesota).

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

Not applicable. For this type of medical device submission focused on physical properties and performance, "ground truth" is established by engineering specifications, validated test methods, and industry standards, not by expert medical consensus on human-generated data. The "experts" would be the engineers and quality control personnel designing and executing the tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and quantitative (e.g., measuring dimensions, observing corrosion, measuring tensile strength). There is no "adjudication" in the sense of resolving disagreements between human observers. The outcomes are determined by adherence to pre-defined engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The MIVI Q Distal Access Catheter is a physical medical device (catheter) with no AI/ML components or human diagnostic interpretation associated with its direct function.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, this is not applicable. The MIVI Q Distal Access Catheter is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

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

• Engineering Specifications: Pre-defined dimensional requirements, material properties, and functional performance targets derived from the device's intended use and comparison to the predicate device.
• Industry Standards: Relevant ISO or ASTM standards governing medical device testing (though not explicitly listed in this summary, they are implicitly followed in such submissions).
• Predicate Device Performance: The established performance and safety profile of the legally marketed predicate device (MIVI Mi-EXT Extension Catheter, now branded as the MIVI Q Distal Access Catheter K163233) serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. There is no training set for this device.

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The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostasis Valve (RHV), Tuohy Borst Valve with Sideport, and two peel away introducer sheaths. The RHV and Tuohy Borst valve with sideport are used for flushing, insertion of catheters, and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.

The provided document describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the AXS Catalyst 7 Distal Access Catheter to its predicate devices, rather than proving it meets specific acceptance criteria for a new, non-predicate device. The entire submission focuses on establishing substantial equivalence for 510(k) clearance.

Here's an analysis of the provided information, framed around the requested categories:

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

The document does not explicitly provide a table of "acceptance criteria" alongside specific numerical "reported device performance." Instead, for each test, it outlines the "Purpose" (which implicitly defines the acceptance criteria) and a "Conclusion" stating whether the device "meets acceptance criteria" or was "acceptable."

Here's a summary derived from the "Performance Data – Bench Testing" section:

Biocompatibility Testing (Table 3):

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The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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) or who failed IV t-PA are candidates for treatment.

The AXS Catalyst 7 Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in the removal of thrombus from the neuro vasculature using continuous aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostasis Valve (RHV), Tuohy Borst Valve with Sideport, and two peel-away introducer sheaths. The RHV and Tuohy Borst valve with sideport are used for flushing, insertion of catheters, and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.

When used as part of the aspiration system, the AXS Catalyst Distal Access Catheter requires a minimum vacuum pressure of -68 kPa [-20.08 in Hg] from an external device (Medela Dominant Flex Pump). Bench and Animal testing utilizing the Medela Dominant Flex Pump and Suction Jar, AXS Universal Aspiration Tubing, and AXS Universal Liner Set were conducted to successfully demonstrate aspiration.

The provided document is a 510(k) summary for the AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter). It details the device's characteristics, comparison to predicate devices, and a summary of performance data (bench, animal, and clinical) to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document presents its "acceptance criteria" implicitly through the "Conclusions" column in Table 2 (Performance Data - Bench Testing), Table 3 (Performance Data - Animal Testing), and Table 4 (Biocompatibility Studies). The acceptance criteria are "meets acceptance criteria," "acceptable," "equivalent," or "PASS."

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

The document does not explicitly state the numerical sample sizes (e.g., number of catheters tested) for each bench test. It mentions qualitative assessments like "Visually inspect" or "Prepare sample for test." For the animal study, it mentions "porcine test subjects" but does not give the exact number.

• Provenance: The studies were conducted by Stryker Neurovascular ("Submitter Name, Address, and Content" section) and likely took place at their facilities or certified labs. The animal study was conducted "in compliance with applicable requirements in the GLP regulation (21 CFR Part 58)," which specifies good laboratory practices, but not geographic provenance. The clinical data was not from a study conducted by the submitter but rather a "review was conducted considering published clinical study articles that featured the Predicate devices." This implies that the clinical data is retrospective from existing literature, and its origin would vary based on those publications.

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

This information is not provided in the document. The studies described are primarily bench and animal tests, along with a review of published clinical articles. There's no mention of expert consensus or human readers being used to establish ground truth for a test set in the context of device performance, as one might find for an AI/imaging device. The "In-vitro Usability Study" mentions "multiple physician users" but doesn't specify their number or qualifications, nor is it described as establishing "ground truth" for the device's technical performance, but rather "evaluat[ing] aspiration integrity, ability to restore flow and the durability and kink resistance."

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

This information is not applicable/not provided. Adjudication methods are typically used in studies involving human readers or expert panels evaluating diagnostic outputs (like images), especially in the context of establishing ground truth where there might be disagreement. The studies described here are primarily engineering (bench) and animal model tests, where outcomes are determined by physical measurements or biological responses, not human interpretation requiring 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

This is not applicable. The device is a "Percutaneous Catheter" (specifically, a distal access catheter for stroke treatment), not an AI-based diagnostic or assistive software. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance would not be relevant to this device's submission.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

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

For the bench and animal tests, the "ground truth" is established through physical measurements, established engineering test methods (e.g., EN ISO 10555-1, EN 1707, EN ISO 14971), and biological evaluations (histopathology in the animal study). For the biocompatibility tests, it's based on established ISO standards (EN ISO 10993-1 and sub-parts) and analytical chemistry results. There is no mention of expert consensus or pathology reports serving as "ground truth" in the way it might for a diagnostic imaging AI. The "clinical performance" relies on a review of published clinical outcomes of predicate devices, leveraging their established safety and efficacy rather than generating new outcomes data for the subject device.

8. The sample size for the training set

This is not applicable/not provided. The device is a physical medical device, 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. As there is no training set for a physical device, there's no ground truth established for one.

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The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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) or who failed IV t-PA are candidates for treatment.

The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The AXS Universal Aspiration System is designed for use within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries. The AXS Universal Aspiration System is composed of the following components:

• AXS Catalyst™ Distal Access Catheter ●
• AXS Universal Aspiration Tubing
• . Medela Dominant Flex Pump
• AXS Universal Liner Set
  The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter. The catheter shaft has a hydrophilic coating to reduce friction during use, includes a radiopaque marker on the distal end for angiographic visualization, and includes a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostastic Valve (RHV), Tuohy Borst Valve with Sideport, and Peel Away Introducer. The Rotating Hemostastic Valve and Tuohy Borst valve with sideport are used for flushing, insertion of catheters, and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst. The AXS Catalyst Distal Access Catheter is the only component of the AXS Universal Aspiration System that is used intravascularly.
  The AXS Universal Aspiration Tubing serves as a conduit to supply vacuum from the Medela Dominant Flex Pump to the distal tip of the AXS Catalyst Distal Access Catheter. The AXS Universal Aspiration Tubing provides a connection between the sterile and nonsterile environments. The proximal end of the AXS Universal Aspiration Tubing is connected to the AXS Universal Liner Set (outside of the sterile environment) while the distal end of the AXS Universal Aspiration Tubing is connected to the AXS Catalyst Distal Access Catheter (inside the sterile environment). The AXS Universal Liner Set is connected to the Medela Dominant Flex Pump (also outside of the sterile environment).
  The Medela Dominant Flex Pump is designed to generate vacuum for the AXS Universal Aspiration System. When used as part of the AXS Universal Aspiration System, the AXS Catalyst Distal Access Catheter requires a minimum vacuum pressure of -68 kPa [-20.08 in Hg] from the Medela Dominant Flex Pump. The Medela Dominant Flex Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.
  The AXS Universal Liner Set is provided non-sterile and consists of an individually packaged canister liner and a ClotFinder specimen cup. The AXS Universal Liner Set is offered with and without a desiccant. The AXS Universal Liner Set is single-use and the repository for aspirated material.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding the AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System. This type of document is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.

The document does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance. Instead, it details bench testing and animal studies to demonstrate the substantial equivalence of the mechanical device (catheter and aspiration system) to existing predicate devices.

Therefore, many of the requested information points regarding AI/algorithm performance, such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this document. The document focuses on the physical and functional characteristics of a medical device intended for mechanical thrombectomy in stroke patients.

Nonetheless, I will extract and present the information that is available in the document, framed within the context of the device's mechanical performance and substantial equivalence.

Device Acceptance Criteria and Performance (Based on Mechanical/Physical Testing)

The acceptance criteria for this device are demonstrated through various bench tests and animal studies, showing that the AXS Catalyst Distal Access Catheter, when used as part of the AXS Universal Aspiration System, performs similarly to its predicate devices concerning its physical properties, functionality, and safety. There is no AI component in this device.

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

Since this is a 510(k) submission for a mechanical device, formal "acceptance criteria" are not listed in terms of numerical thresholds for clinical outcomes in the same way they would be for an AI device. Instead, the "acceptance criteria" are implicit in the conclusion that "All test samples met acceptance criteria" or "met established criteria," demonstrating parity or superiority to predicate devices in specific bench and animal tests. The device's performance is reported as meeting these (unspecified) criteria.

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

• Bench Testing: The document states that "All test samples met acceptance criteria" for various bench tests, but the specific numerical sample sizes for each test (e.g., number of catheters tested for aspiration flow rate, tip buckling, etc.) are not explicitly provided in this summary. The tests were likely conducted in a controlled laboratory environment.
• Animal Study: "Porcine test subjects" were used. The exact number of animals is not specified in this summary. The studies were conducted in compliance with GLP regulation (21 CFR Part 58), typically implying rigorous, controlled experimental settings. Data provenance would be from these controlled in-vivo studies.

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 as the device is mechanical and its evaluation does not involve image interpretation or AI-driven diagnostic tasks requiring expert ground truth for a test set in the traditional sense. The "ground truth" for mechanical properties is established by physical measurement, and for biological response by expert pathological/angiographic assessment. The "usability study" mentions "Multiple User evaluation," but does not detail their qualifications or roles in "ground truth" establishment beyond performing the procedure.

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

• This information is not applicable. Adjudication methods are relevant for subjective assessments, typically in AI or interpretive diagnostic studies. The testing here is largely objective mechanical/biological evaluation.

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

• No, an MRMC study was not done. This type of study is typically performed for diagnostic imaging devices or AI systems where human readers interpret cases. This submission is for a mechanical medical device (catheter and aspiration system).

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

• No. This is not an algorithm-based device. "Standalone" performance would refer to the mechanical operation of the device in a bench or animal model without direct human intervention in the data results (e.g., measuring flow rate via automated systems), which is implied in the bench testing.

7. The type of ground truth used:

• Bench Testing: Physical measurements, engineered models (e.g., tortuous anatomical models, neurovascular challenge path model), and established laboratory testing standards.
• Animal Study: Vascular response assessed by contrast angiography and histopathology. These are considered objective, often expert-interpreted, assessments of the biological effects of the device.

8. The sample size for the training set:

• Not applicable. This document describes the testing and validation of a mechanical medical device, not an AI/machine learning model. Therefore, there is no "training set" in the context of data for model development.

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

• Not applicable. As there is no AI/ML training set, this question is irrelevant to the provided document.

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