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The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

The provided 510(k) clearance letter pertains to a Micro Catheter and describes its performance and testing to demonstrate substantial equivalence to a predicate device. This document does not discuss an AI/ML powered device, nor does it present data from a study involving human readers or the establishment of ground truth for AI model training or testing. Therefore, I cannot address most of your specific questions related to AI device evaluation.

However, I can extract the acceptance criteria and performance data for the Micro Catheter based on the provided text.

Acceptance Criteria and Device Performance for Micro Catheter

The document describes the testing performed on the Micro Catheter to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are implied by the "Results" column in the tables, indicating whether the device met the required performance standards for each test.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for a medical device like a micro catheter focuses on engineering and biocompatibility performance rather than AI-specific metrics. The "acceptance criteria" are implicitly met if the "Results" indicate compliance, comparability to a predicate, or "met the acceptance criteria."

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The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils.

The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro 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 microcatheter 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 vasculature.

The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.

Here's a summary of the acceptance criteria and the study details for the Wallaby 017 Micro Catheter, based on the provided document.

It's important to note that the document describes a medical device rather than an AI/ML powered device. Therefore, many of the typical questions for AI studies (like sample size for test/training sets, ground truth methodology with experts, adjudication, or MRMC studies) are not applicable here. The "performance" being evaluated is the physical and functional performance of the catheter itself, not the performance of an algorithm.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on passing various bench tests and biocompatibility evaluations. The full "acceptance criteria" are implied by "met all pre-defined acceptance criteria" for each test. Specific numerical thresholds for each criterion are not provided in this summary but would have been defined in detailed test protocols.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Applicable for a medical device cleared via 510(k))

1. 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 exact sample sizes (N-values) for each bench test. For example, "The device was evaluated..." doesn't indicate if this was one unit or multiple units.
   • The data provenance is from non-clinical bench testing performed by Wallaby Medical for regulatory submission in the United States (as indicated by the FDA 510(k) process). It is prospective in the sense that the testing was conducted specifically to support this regulatory submission.
   • No human-collected test sets (like medical images) are involved, so country of origin of data in that sense is not applicable.

2. 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):

   • Not applicable as this is a physical medical device, not an AI/ML algorithm. "Ground truth" for physical device performance is established through standardized engineering and biological tests against predefined specifications and industry standards (e.g., ISO standards).
   • For the "Physician Validation (Usability)" test, it states "The device was evaluated in a simulated anatomy model by physicians." The number and qualifications of these physicians are not detailed in this summary.

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

   • Not applicable. This concept pertains to expert review for AI/ML algorithm performance. For physical device testing, results are typically objective measurements or observations against predefined 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:

   • Not applicable. This is a non-AI medical device without human "readers" in the context of an AI study.

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

   • Not applicable. The device itself is standalone in the sense that it is a physical product, but the concept of "standalone algorithm performance" does not apply.

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

   • "Ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ISO 10555-1, ISO 594-1, ISO 11135:2014, ISO 10993 series, USP ), and comparison to legally marketed predicate devices. The results of the bench tests and biocompatibility evaluations, when conforming to these standards and specifications, are the "ground truth" for proving the device's safety and effectiveness.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML model for which to define a training set.

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

   • Not applicable. There is no AI/ML model or training set.

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The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vessels. The Micro Catheter and Guidewire system is also infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The system should not be used in cerebral vessels.

Micro Catheter and Guidewire System consists of a catheter, a guidewire, and accessories. The accessories include a flushing device, a shaping mandrel, an insertion tool, a torque device and a peel-able tube.

The catheter is consist of a hub, a stress relief tube and a catheter shaft. The catheter shaft has three layers. The inner layer is a PTFE tube, the middle layer is consist of stainless steel wire reinforce and platinum-iridium alloy radiopaque distal marker. And the outer layer is polyamide. There is also a hydrophilic coating on the catheter surface.

The guidewire is consist of a nitinol core, a polymer jacket with PVP hydrophilic coating over its entire surface, and a spring coil at distal. It has a white marker at the proximal to indicate the length inserted into human body and its relative position with the catheter.

The provided text is a 510(k) summary for the "Micro Catheter and Guidewire System" and predominantly focuses on the regulatory submission process, device description, and a comparison to a predicate device. It briefly mentions performance testing but does not provide the detailed acceptance criteria or the specific results required to fill out a table of acceptance criteria vs. reported device performance.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or answer most of the questions about the study design, sample sizes, expert involvement, or ground truth establishment.

The document states that "Nonclinical tests demonstrate that the Micro Catheter and Guidewire System is substantially equivalent to the predicate device which is currently marketed for the same intended use." This indicates that the study was primarily a nonclinical (bench) testing and biocompatibility evaluation to demonstrate substantial equivalence, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy.

Here's what can be inferred or stated as "not provided" based on the text:

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

• Not provided in the document. The document lists types of tests (e.g., "Peak tensile force of catheter," "Coating test of guidewire," "Burst pressure under static conditions") under "Bench Testing", but it does not specify the quantitative acceptance criteria for these tests nor the numerical results achieved by the device.

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

• Sample size: Not provided. The document states that "Biocompatibility evaluation... was conducted in accordance with current standards" and lists various bench tests, but the number of units/samples tested for each is not specified.
• Data provenance: The tests are "Nonclinical tests," likely performed at Suzhou Hengrui Hongyuan Medical Co., Ltd. or a contracted lab in China, given the submitter's location. There is no mention of human subject data, so "retrospective or prospective" is not applicable in the typical sense of clinical studies.

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

• Not applicable. This device is a micro catheter and guidewire system, not a diagnostic AI device requiring expert interpretation for ground truth. The "ground truth" for this type of device would be established engineering specifications and material properties, against which the device's performance is measured in bench tests.

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

• Not applicable. This pertains to studies where human reviewers assess data, often clinical images. For bench testing of a micro catheter and guidewire, "adjudication" methods are not relevant. Test results are typically objective measurements.

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. This is a medical device, not an AI/CADe/CADx system for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• Not applicable. This is not an algorithm-based device. Its performance is intrinsic to its physical properties and design.

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

• For biocompatibility: Adherence to ISO standards (e.g., ISO 10993 series).
• For bench testing: Engineering specifications, industry standards, and predicate device performance. These would serve as the "ground truth" or acceptance criteria for mechanical and physical properties.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. (See point 8).

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The Micro Catheter is intended for selective delivery of therapeutic devices and infusion of contrast media into the peripheral and neuro vasculature.

The proposed device Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the peripheral and neuro vasculature. The proximal end of the catheter incorporates standard Luer adapter to facilitate the attachment of accessories. The outer surface of the catheter has a lubricious coating at the distal end of the Micro Catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The device is intended for single use and is provided sterile.

The provided document is a 510(k) Pre-market Notification for a medical device called "Micro Catheter". It details non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to an AI/Machine Learning model, nor does it discuss human reader performance, AI assistance, or the establishment of ground truth for such models. The document focuses on the physical and biological performance of a catheter device through standard engineering and biocompatibility tests.

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

• A table of acceptance criteria and the reported device performance: The document provides a table of test methods and results for non-clinical performance and biocompatibility, but these are for the physical device, not an AI model.
• Sample sized used for the test set and the data provenance: Not applicable as no AI/ML model testing is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: 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.

The document pertains to the regulatory clearance of a physical medical device (a micro catheter) and its performance is evaluated through standard engineering and biological compatibility tests, not through the evaluation of an AI or machine learning algorithm.

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KDL Micro catheter is used to provide support, to facilitate the placement of guidewires in the peripheral and coronary vasculature, and can be used to exchange one guidewire for another. It is also intended to assist in the delivery of diagnostics, embolic, or therapeutic materials into peripheral and coronary vessels

The KDL Micro catheter is available in two French configurations, 2.3F (proximal)/1.6F (distal) and 2.5F (proximal) /1.8F (distal), 110cm, 130cm, 180cm of effective lengths. The proposed device consists of Hub with luer connector, strain relief, catheter shaft, a radiopaque marker and soft tip. The catheter shaft and radiopaque marker consist of 3 layers, an outer layer of Eurelon or pebax tube containing BaSO4, a middle layer of stainless steel braid mesh and an inner layer of PTFE tube, in addition, the middle layer of radiopaque marker consist of Platinoiridium. The radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The soft tip consists of 2 layers, an outer layer of pebax tube containing BaSO4, an inner layer of PTFE tube. The outer surface of the micro catheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the micro catheter into the vasculature.

The distal tip of micro catheter is offered in straight (MCS) and swan neck (MCM) configurations.

All models of the catheter are designed to accept a maximum guidewire diameter of 0.010 inch or 0.014 inch.

The provided text is a 510(k) summary for the KDL Micro catheter. It describes the device, its intended use, comparison to predicate devices, and performance data from bench and biocompatibility testing. However, it does not contain information about an AI/ML powered device or a study involving human readers, expert ground truth adjudication, or statistical metrics like sensitivity, specificity, or AUC. Therefore, I am unable to fulfill the request based on the provided input.

The document pertains to a Class II medical device (percutaneous catheter) and its substantial equivalence determination to previously cleared predicate devices. The performance data presented are for the physical and biological characteristics of the catheter, not the performance of an AI/ML algorithm.

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The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Rebar" Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.

The provided text does not describe a study involving a device that uses AI or machine learning. Instead, it describes a 510(k) premarket notification for a medical device called the "Rebar™ Micro Catheter." This submission is focused on demonstrating substantial equivalence to an existing predicate device based on material changes (e.g., to the hub material and adhesive) and associated non-clinical bench testing.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided document pertains to a traditional, non-AI medical device clearance.

The document discusses:

• Device: Rebar™ Micro Catheter (a vascular microcatheter)
• Purpose: Delivery of interventional devices or contrast media into the vasculature.
• Regulatory Pathway: 510(k) premarket notification, aiming for substantial equivalence to a previously cleared Rebar™ Micro Catheter (K093750).
• Changes: Primarily changes to the material of the catheter hub (from Polypropylene to Trogamid) and the adhesive used.
• Proof of Equivalence: Non-clinical bench testing and biocompatibility data, rather than clinical trials or AI/ML performance studies.

The acceptance criteria listed are for physical and functional properties of the catheter (e.g., hub integrity, pressurization, tensile strength) and not related to AI/ML performance metrics like accuracy, sensitivity, or specificity. There is no mention of a test set, ground truth acquisition involving experts, MRMC studies, or training sets, as these concepts are not applicable to the type of device and study described.

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The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

The Marathon™ Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet, guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the guiding catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Marathon™ Flow Directed Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and bench testing.

However, the provided text DOES NOT contain information regarding:

• AI/Algorithm performance: This document is for a physical medical device, not an AI or algorithmic diagnostic tool.
• Acceptance criteria for an AI model: The acceptance criteria listed are for physical characteristics and performance of a catheter.
• Sample size for a test set or training set for an AI model: No AI model is being evaluated.
• Data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance: These are all concepts relevant to the evaluation of AI/ML-based medical devices or diagnostic algorithms, which are not the subject of this document.
• Effect size of human reader improvement with AI assistance: Not applicable.
• Type of ground truth used (pathology, outcomes data, etc.): Not applicable in this context.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI/ML model, nor can I answer the specific questions about AI model testing that were asked.

The document instead focuses on demonstrating the substantial equivalence of the Marathon™ Flow Directed Micro Catheter to a predicate device (K093750) through bench testing and biocompatibility assessments.

Here's the relevant information about the device's acceptance criteria and proven performance based on the provided text, re-framed to address the questions where applicable, but noting when the question is not relevant to this document.

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

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

• This document is for a physical medical device and discusses bench testing, not an AI model's test set.
• Sample Size for Bench Testing:
  • Specific sample sizes for each bench test are not explicitly stated in this summary table, only the results. However, typical regulatory submissions for physical devices involve testing a statistically representative number of units.
• Data Provenance: Not applicable in the terms used for AI. The data originates from internal laboratory bench testing conducted by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).
• Retrospective/Prospective: Not applicable in this context. These are lab tests.

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

• Not applicable. This device is evaluated through engineering bench tests and biocompatibility testing, not through expert-labeled diagnostic data for an AI model.

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

• Not applicable. This is for a physical device, not an AI test set requiring human 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 document is about a physical medical device (catheter), not an AI system that assists human readers. No MRMC study was conducted or is relevant.

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 consensus, pathology, outcomes data, etc.):

• For the biocompatibility tests, the "ground truth" is established by standard biological assays and the observation of cellular and blood responses against established safety thresholds.
• For the bench performance tests, the "ground truth" is the physical properties and performance characteristics of the catheter as measured against predefined engineering specifications and international standards (e.g., ISO 10555-1, ISO 80369). These are objective measurements.

8. The sample size for the training set:

• Not applicable. There is no AI model requiring a training set described here.

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

• Not applicable. There is no AI model or training set described here.

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The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.

The Odyssey Micro Catheter is a single lumen catheter constructed using a PTFE liner inside of metallic coil and a polymer outer layer. The distal tip is a radiopaque polymer material and the distal 30 cm to 60 cm of the micro catheter has a hydrophilic coating. The key components of the catheter are the core, coil(s), tip, and coatings.

The provided text describes a 510(k) premarket notification for a medical device called the Odyssey Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study in the typical sense of a novel AI/software medical device.

Therefore, the information requested for AI/software-centric studies (like sample sizes for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission, as it concerns a physical medical device and its performance in in vitro bench tests.

However, I can extract the acceptance criteria (inferred from the tests performed) and summarize the study's findings:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria values for each test but states that the Odyssey Micro Catheter "met all predetermined acceptance criteria." The "reported device performance" is essentially that the device performed comparably or favorably to the predicate and met established standards.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The testing involved in vitro bench tests on the device itself. The number of units tested for each specific bench test is not detailed.
• Data Provenance: Not applicable in the context of human data. The "study" here refers to "Performance in vitro bench tests" conducted by the manufacturer, Heraeus Medical Components, LLC.

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

• Not Applicable. Ground truth, in this context, would refer to the validated methods and standards used for in vitro testing (e.g., ISO standards, internal validation of test equipment). This isn't about expert consensus on clinical data.

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

• Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or when establishing ground truth from expert readings. This was in vitro bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a physical micro catheter, not an AI/software device that would assist human readers.

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

• Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's functional performance against engineering and safety specifications in vitro.

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

• The "ground truth" for the performance "study" was established by validated international standards (ISO 10555-1:2013, ISO10993-1:2009) and FDA guidance (G95-1) for in vitro functional performance and biocompatibility. The specific outcomes were measurements of physical and biological properties.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set."

Summary of the Study:

The "study" described in the 510(k) summary involves a series of in vitro bench tests designed to demonstrate the safety and effectiveness of the Odyssey Micro Catheter by proving its substantial equivalence to a legally marketed predicate device (ASAHI Corsair Microcatheter, K151103).

The key aspects of the study include:

• Tests Conducted: Biocompatibility testing (cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, in-vivo thrombogenicity, chemical characterization), particulate testing, corrosion resistance, dimensional inspection, sterile package integrity, tensile strength, torque strength, kink resistance, radiopacity, flow rate, and burst pressure/freedom from leakage.
• Standards Followed: ISO 10555-1:2013 (Intravascular catheters - sterile and single-use catheters - Part 1: General requirements) for functional testing, and ISO10993-1:2009 and G95-1 (FDA guidance) for biocompatibility testing.
• Outcome: The Odyssey Micro Catheter "met all predetermined acceptance criteria and compared favorably with the predicate device." The study supported claims of substantial equivalence based on indications for use, physical and technological characteristics, and comparative device testing, without raising new questions of safety and effectiveness.

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The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Reverse™ Micro Catheter is a single lumen catheter designed to be introduced over a steerable guide wire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate vessel navigation. The micro catheter incorporates a PTFE liner to facilitate movement or introduction of devices passed through its lumen. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability. The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID.

The document you provided describes a medical device, the Reverse™ Micro Catheter, and its non-clinical performance evaluation for substantial equivalence to a predicate device. It does not describe a study involving an AI model or a specific algorithm. Therefore, I cannot provide information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, or comparative effectiveness studies in the context of AI.

The document focuses on demonstrating that the modified Reverse™ Micro Catheter is substantially equivalent to a previously cleared device (Reverse™ Medical Microcatheter, K130858) based on non-clinical performance data.

Here's a breakdown of what the document does provide, structured to address the spirit of your request where possible, but re-contextualized for a medical device rather than an AI study:

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

The document states that "All testing passed the acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. The performance results are reported as successful completion of tests without new safety or effectiveness issues.

• Dimensional requirements
• Lubricity/friction
• Particulates
• Coating characterization
• Simulated use device compatibility
• Simulated use navigation and delivery
• Shelf-life verification (1 year accelerated aging) | "All testing passed the acceptance criteria."
  "Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness." | Implicitly, meeting specifications and predicate equivalence. |
  | Biological Safety | - MEM Elution Cytotoxicity
• Guinea Pig Maximization Sensitization
• Intracutaneous Reactivity
• Acute System Injection
• Materials Mediated Rabbit Pyrogen
• Hemolysis Direct Contact
• Hemolysis Indirect Extract Method
• Complement Activation
• In vivo Thrombogenicity
• Genotoxicity (Ames Assay, in vitro Mouse Lymphoma, in vivo Mouse Micronucleus)
• USP Physicochemical | "Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use." | Compliance with ISO 10993-1 and related standards. |
  | Microbial Assessments | - Bioburden
• Endotoxin
• Sterility assurance | "Sterilization has been validated and is controlled... to provide a minimum SAL of 10-6." | Minimum SAL of 10-6; compliance with ISO 11135-1. |
  | Packaging Validation | - Visual Inspection
• Bubble Leak
• Seal Strength | "To evaluate integrity of the packaging configuration." (Implied successful evaluation) | Implicitly, maintaining package integrity after sterilization, environmental conditioning, and simulated shipping. |

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

The document does not specify sample sizes for individual bench tests, biological safety tests, or packaging validation. It refers broadly to "comprehensive verification and validation activities." The data provenance is internal testing by the manufacturer, Medtronic Neurovascular, for a new medical device. This is prospective testing of the device being submitted for clearance.

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

This concept is not applicable to this type of device submission. There isn't "ground truth" established by experts in the context of an AI algorithm's performance. Instead, the "truth" is determined by established engineering specifications, biocompatibility standards, and functional performance requirements for a physical medical device.

4. Adjudication method for the test set

Not applicable. There's no human-in-the-loop performance or diagnostic adjudication involved for this physical device's non-clinical testing.

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 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 device. The testing described is "standalone" in the sense that it's the device itself being tested, not an algorithm.

7. The type of ground truth used

For this medical device, the "ground truth" for the non-clinical tests would be:

• Engineering Specifications: Conformance to pre-defined dimensional, material, and performance requirements (e.g., inner diameter, lubricity, navigation).
• International Standards: Adherence to established standards for biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), and packaging integrity.
• Predicate Device Performance: Demonstrating that the subject device performs "at least as safe and effective as the predicate device."

8. The sample size for the training set

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device.

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The FluidiTube® 2.7F Infusion Micro Catheter is intended to facilitate infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels and all coronary vessels. It is also intended for drug infusion in intra-arterial therapy and embolic materials for hemostasis. The FluidiTube® 2.7F Infusion Micro Catheter is not to be used in cerebral blood vessels.

The FluidiTube® 2.7F Infusion Micro Catheter is a tapered 2.7F/2.9F single lumen catheter with a luer lock hub designed to facilitate the access of distal vasculature over a guidewire. The FluidiTube® has a semi-rigid proximal shaft that becomes progressively more flexible towards the distal end. The shaft is reinforced with braided stainless steel wire for kink resistance. The inner lumen is lined with a lubricious material to facilitate the movement of a guidewire. The outer surface of the catheter has a hydrophilic coating that becomes lubricious when wet with saline or blood. The FluidiTube® catheter is introduced to the target location through a guiding catheter 0.038" (0.97 mm) or larger and is compatible with 0.021" (0.53 mm) guidewires or smaller. Device configurations consist of one profile size (2.7F) with two different usable lengths (110cm, 130cm). The final device is packaged in a Tyvek pouch and sterilized by ethylene oxide (EO). The device is for single use only.

The document provided is a 510(k) premarket notification for the Callisyn FluidiTube® 2.7F Infusion Micro Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than full clinical trials for novel devices. Therefore, the "acceptance criteria" and "device performance" are typically framed in terms of equivalence to the predicate and meeting established engineering and biocompatibility standards, rather than specific performance metrics like sensitivity/specificity for diagnostic devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical device (infusion micro catheter), "acceptance criteria" and "device performance" are defined by the comprehensive non-clinical testing and a comparative animal study demonstrating equivalence to the predicate device. The performance is assessed against established engineering standards and functional requirements relevant to the device's intended use.

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

• Test Set Sample Size: For the simulated use environment (animal study), the document states the study was conducted in "a healthy male Yorkshire swine." This indicates a sample size of one animal.
• Data Provenance: The animal study was prospective, conducted in a simulated use environment using an animal model (Yorkshire swine). The country of origin of the data is not explicitly stated, but it's part of a submission to the U.S. FDA.

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

• Number of Experts: Two operators (presumably veterinarians or interventional specialists/researchers experienced in animal models for medical device testing) participated in the animal study.
• Qualifications of Experts: Their specific qualifications (e.g., years of experience, specific board certifications) are not detailed in the document. They are referred to as "Operators."

4. Adjudication Method for the Test Set

The document states: "Both Operators rated all test and control microcatheters as acceptable for:" followed by a list of performance criteria. This implies that:

• There was no explicit adjudication method described beyond the consensus or agreement of the two operators on the "acceptable" rating for all performance features.
• It appears to be a 100% agreement or shared determination approach, as both operators individually rated them as acceptable, and the conclusion mentions "both Operators determined that all study protocol specified acute performance requirements...were successfully met."

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

No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where reader performance is a key metric. For an infusion microcatheter, the focus is on device function, safety, and equivalence to established products.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical instrument, an infusion microcatheter, not an algorithm or AI system. Therefore, a standalone performance study in the context of an algorithm is not relevant.

7. Type of Ground Truth Used (for the animal study / simulated use)

For the animal study, the "ground truth" was established by the direct observation and qualitative assessment by the two experienced operators during and after the procedure in the swine model. This included visual inspection for tracking success, fluoroscopic visualization, compatibility with other devices, functional performance (infusion), and post-procedure integrity assessment of the catheter and animal vasculature. This falls under expert observation/assessment in a simulated environment.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning. The non-clinical testing (biocompatibility, physical/mechanical) establishes the device's inherent properties and performance against specifications.

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

Not applicable. As stated above, there is no "training set" in the machine learning sense for this medical device. The "ground truth" for the non-clinical testing is based on established engineering standards, ISO standards, and other recognized methodologies (e.g., ASTM, USP).

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