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The Cora Microcatheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions of diagnostic contrast.

The CoraFlex and CoraForce Microcatheters (Cora Microcatheters) are single lumen catheters designed to access the peripheral and coronary vasculature. Each configuration has a hydrophilic coated coiled catheter with a braided support matrix, radiopaque distal tip, proximal luer, and "spin-friendly" strain relief. The Cora Microcatheters will also allow for the exchange of guidewires and provide a conduit for delivery diagnostic or therapeutic agents.

This document is a 510(k) clearance letter for medical microcatheters, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, ground truth, and expert involvement for AI device performance is not applicable to this submission.

The FDA clearance is based on non-clinical (bench) testing demonstrating substantial equivalence to a predicate device, as indicated by the following sections:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in a table format. The document states:
"The Cora Microcatheters met all specified criteria and did not raise new questions regarding safety and effectiveness compared to the predicate."
And
"Based on the performance testing, the Cora Microcatheters were found to be substantially equivalent to the predicate."

The specific criteria and direct performance metrics are not detailed in this summary, but the types of tests performed indicate the areas of performance evaluated:

• Simulated Use
• Dimensional Verification
• Radiopacity
• Leak Testing
• Kink Resistance
• Corrosion Resistance
• Component Integrity
• Bond Integrity
• Particulate Testing
• Torque Testing
• Burst Testing
• Lubricity and Coating Integrity Testing
• Design Validation/Usability
• Sterility Testing
• Biocompatibility Assessment

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not explicitly stated in the provided document. The study was non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a non-clinical device clearance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a non-clinical device clearance.

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 a non-clinical device clearance and does not involve AI or human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a non-clinical device clearance and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device would be established by engineering specifications and industry standards for medical device performance, as evaluated through bench testing.

8. The sample size for the training set:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

9. How the ground truth for the training set was established:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

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The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

The provided text is a 510(k) summary for a medical device (Excelsior XT-27 Microcatheters) and details its acceptance criteria and the study performed to demonstrate substantial equivalence, but it does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and data provenance) are not applicable to this document.

However, I can provide the acceptance criteria and study information that is available for this mechanical microcatheter from the document.

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

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

• Sample Size for Test Set: The document does not specify the exact number of samples (e.g., number of microcatheters tested) used for each bench test. It mentions testing with "ancillary devices that represent worst-case sizes" for the Guide Catheter Compatibility test and "worst-case sized ancillary devices and interventional devices" for the Tensile Strength test.
• Data Provenance: The study is described as "Bench testing," indicating it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects.

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):

• Not applicable as this is a mechanical device performance study, not an AI/ML diagnostic or prognostic study requiring expert opinion for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

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

• Not applicable for the same reason as point 3. Bench testing results are typically adjudicated by meeting predefined engineering specifications and criteria, not by expert consensus in the same way as diagnostic reads.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices, which is not what this device is.

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

• Not applicable. This is a physical medical device (microcatheter), not an algorithm.

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

• The "ground truth" in this context is based on engineering specifications and performance criteria for the physical device. For example, for tensile strength, the ground truth would be a defined minimum force the joints and marker band must withstand without failure. For compatibility, it would be the ability to successfully deliver and retrieve the microcatheter within the specified guide catheter with acceptable force.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable for the same reason as point 8.

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The COREPASS FLEX/CONTROL microcatheters are indicated for:
· supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature).
· exchanging guidewires in the coronary and peripheral vasculature.
· the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

The COREPASS FLEX/ CONTROL microcatheters are singe lumen catheters, offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135cm or 150cm, designed for use in coronary, peripheral, and abdominal vasculature. The COREPASS FLEX/CONTROL share identical shaft profile 2.5F (0.032'') but different distal profile, including 2.2F (0.028'') for the 2.2F configuration (COREPASS FLEX) and 2.5F (0.032'') for the 2.5F configuration (COREPASS CONTROL). The catheter consists of five sections: hub with a female luer connector, catheter body shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

The provided text is a summary of a 510(k) premarket notification for a medical device (COREPASS Modular Microcatheter) and does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic tool. The document focuses on the regulatory clearance process for a physical medical catheter device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance (in the context of an AI device)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The "Performance Data" section in the document lists various physical and material-related tests conducted on the microcatheter (e.g., Sterilization, Shelf-Life Performance, Particulate Evaluation, Dimension Inspection, Media Flow Rate, Shaft Burst Pressure, Guidewire Compatibility, Coating Integrity, Flexibility and Kinking, Corrosion Resistance, Torque Strength, Tensile Strength, Radiopacity, and a range of Biocompatibility tests). It simply states:

"The test results of COREPASS Modular Microcatheter met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of COREPASS Modular Microcatheter are suitable for its intended use."

This confirms that acceptance criteria exist for these physical properties and that the device met them, but the document does not elaborate on what those specific criteria are nor does it describe a study design in the way one would for an AI/software as a medical device (SaMD).

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The Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

The Access25 Delivery Microcatheter (Access25) is a single lumen medical device designed to aid a physician in accessing distal vasculature when used in conjunction with a guide catheter and micro guidewire. The Access25 Delivery Microcatheter is supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired.

This document pertains to the Access25™ Delivery Microcatheter by Penumbra, Inc. This is a medical device and not an AI/ML powered device, therefore some relevant sections of the query will not be applicable.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML algorithm, there is no training set or its associated ground truth establishment process. The "ground truth" in the device development context refers to the established performance requirements and standards against which the device is tested.

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The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.

The pNOVUS 21 Microcatheter (pNOVUS 21) is a single use microcatheter, supplied sterile using ethylene oxide (EtO), in a packing hoop, within a sealed pouch and shelf carton configuration. An introducer sheath and shaping mandrel are supplied on a backing card inside the pouch. The packaging is designed to facilitate ease of handling and aseptic presentation of the device.

The pNOVUS 21 Microcatheter is a variable stiffness single lumen catheter. The pNOVUS 21 has a radiopaque marker on the distal end to facilitate fluoroscopic visualization, and a luer hub on the proximal end to facilitate the infusion of diagnostic agents and the smooth transfer of other devices (e.g., guidewires) into the inner lumen of the microcatheter. The distal end of the microcatheter's external surface has a hydrophilic coating applied for increased lubricity during use. The pNOVUS 21 has a straight tip. Steam shaping of the distal tip allows for one-time customizing of the tip shape. There are two models of the pNOVUS 21 Microcatheter, the device model # are:

• PNOV-21-160
• PNOV-21-150

The pNOVUS 21 Microcatheter is intended for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. pNOVUS 21 is generally inserted either through a sheath or guide-catheter.

The provided text is a 510(k) summary for the pNOVUS 21 Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and biocompatibility), rather than a study involving an AI/software component with specific acceptance criteria related to accuracy, sensitivity, or human-in-the-loop performance.

Therefore, many of the requested elements for describing the acceptance criteria and study that prove an AI/software device meets acceptance criteria are not present in this document. This document describes a traditional medical device (microcatheter), not an AI-powered diagnostic or therapeutic software.

However, I can extract the general "acceptance criteria" and "reported device performance" in the context of this traditional device clearance, which are primarily based on meeting defined specifications and demonstrating comparable performance to a predicate device through bench testing.

Here's an attempt to answer the prompt based on the provided text, acknowledging the limitations due to the nature of the device:

This document describes the 510(k) clearance for the pNOVUS 21 Microcatheter, which is a physical medical device, not an AI software. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating the device's physical and functional performance and biocompatibility through non-clinical testing, rather than metrics like sensitivity, specificity, mAP, FROC, or human reader improvement with AI assistance.

The overarching acceptance criterion for substantial equivalence for this device is that it performs as intended and is as safe and effective as a legally marketed predicate device. This is demonstrated through a comprehensive suite of bench tests and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes numerous bench tests conducted to ensure the pNOVUS 21 Microcatheter performs as intended and is substantially equivalent to its predicate. The "acceptance criteria" for each test are typically that "All samples met the acceptance criteria," "performance is comparable to the predicate," or "conforming to specifications." The "reported device performance" is essentially that these criteria were met.

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

The document does not explicitly state the numerical sample size for each specific non-clinical bench test. It consistently reports "All samples met the acceptance criteria," indicating that a sufficient number of devices were tested to provide statistical confidence for the relevant acceptance criteria and demonstrate performance.

• Data Provenance: The tests were conducted internally by phenox Ltd or by their designated testing partners (e.g., sterilization in Trier, Germany by Rose GmbH). The data is prospective in the sense that it was generated specifically for this regulatory submission through controlled bench testing and laboratory studies.

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

This section is not applicable as this submission is for a physical medical device (microcatheter) and does not involve AI software requiring expert-established ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for these tests are objective, measurable physical properties and performance characteristics (e.g., leak/no leak, pass/fail for specific forces, material properties).

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described because the testing involves objective measurements against predefined specifications, not subjective interpretations requiring consensus from adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement

No MRMC study was done. This is a physical medical device, not an AI software intended to assist human readers. Therefore, there is no discussion of human reader improvement.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective physical and functional measurements and performance specifications, as defined by relevant ISO standards, ASTM standards, and FDA guidance documents. Examples include:

• Absence of cytotoxic effect, sensitization, irritation, systemic toxicity.
• Measured burst pressure, friction force, particulate count, torque strength, flow rate.
• Visual inspection for defects, kinks, or damage.
• Confirmation of specific dimensions (ID, OD, length).
• Compliance with standard requirements for luer fittings, packaging, etc.

These are not "expert consensus" or "pathology" in the sense of a diagnostic interpretation, nor are they "outcomes data" from clinical trials, as clinical trials were not deemed necessary.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. As this is not an AI model, there is no training set or ground truth in that context.

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The CrossFAST™ Integrated Microcatheter Guide Extension System is intended to be used in conjunction with quide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

CrossFAST™ Integrated Microcatheter Guide Extension System (GES) ("Device" or "CrossFAST" (GES") is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. It is intended for use in a cardiac catheterization laboratory by physicians trained in percutaneous, intravascular techniques and procedures. CrossFAST™ GES consists of two catheters: an Inner Catheter. The Outer Catheter is intended to act as an extension to a traditional guide catheter (i.e., "guide extension") and to facilitate delivery of interventional devices within the target vasculature. The Inner Catheter is intended to be pre-loaded into the user and to provide additional support to the Outer Catheter during delivery. Once assembled, the Inneyond the Outer Catheter tip. After the Outer Catheter has been delivered to the target vasculature, the Inner Catheter is removed from the passage of interventional devices. The Device is designed for use in vessels larger than 2.5mm and is not for use in the venous system. The Device is single use and provided sterile via Ethylene Oxide (EO) sterilization. The Device is compatible with standard, off-the-shelf 0.014" lumen inner diameter (ID) and minimum 180cm length guidewires and a minimum 100cm length 6F guide is intended for use with a hemostasis valve.

The provided text does not contain information about the acceptance criteria and study proving device performance for a device involving AI or machine learning. The submission is for a "CrossFAST™ Integrated Microcatheter Guide Extension System," which is a physical medical device (catheter) used in interventional procedures. The performance testing outlined is for mechanical, material, and biocompatibility properties of the catheter, not for an algorithm's performance.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.

The provided text is a 510(k) summary for the SENDERO Microcatheter, a medical device. This document describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

However, the request asks for information typically associated with a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, including details about a test set, expert ground truth establishment, MRMC studies, standalone performance, and training set information.

The provided FDA 510(k) summary for the SENDERO Microcatheter does NOT contain information about an AI/SaMD, nor does it describe a study involving human readers, expert adjudication, or AI performance metrics.

The SENDERO Microcatheter is a physical medical device (a microcatheter) used for infusion, and its clearance relies on non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request as the necessary information regarding AI/SaMD acceptance criteria and study details (test set, ground truth experts, MRMC, training set, etc.) is not present in the provided text.

The document explicitly states: "No clinical studies were required." This further indicates that the type of study described in the prompt (involving human readers, AI performance, etc.) was not conducted for this device's regulatory clearance.

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The Soldier Microcatheter is indicated for use in the blood vessels of the peripheral vasculature. It is intended to assist in the delivery of diagnostic agents and therapeutic agents into the target treatment area.

The Soldier Microcatheter is intended for Prescription Use Only.

The Soldier is a single lumen catheter designed to access small, tortuous vasculature. It is available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal tip of the catheter is radiopaque to aid in visualization under fluoroscopy.

This document is a 510(k) summary for the Embolx Soldier Microcatheter, seeking substantial equivalence to a predicate device (Progreat catheter). As such, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through non-clinical testing. It does not contain information about an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, I am unable to provide information on acceptance criteria and study details for an AI/ML device from this document.

The document primarily details the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device through bench testing and biocompatibility assessments, rather than an AI/ML study.

Here's an analysis of the provided text, focusing on the available information regarding the "Soldier Microcatheter" as a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML context):

The document does not present a formal table of "acceptance criteria" versus "reported device performance" in the typical sense of numerical thresholds met by specific metrics from a study. Instead, it lists various non-clinical tests performed and states that "Results from each test met the defined acceptance criteria" for biocompatibility and "All tests met the pre-defined performance criteria" for shelf-life. For design verification, it states "Performance testing was conducted to ensure the safety and effectiveness of the Soldier Microcatheter and to demonstrate substantial equivalence to the predicate device: Progreat catheter."

Below is a summary of the types of tests conducted and the general performance statement, as the specific numerical acceptance criteria and results are not detailed in this public summary.

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

The document describes non-clinical bench testing. Therefore, the concept of "test set" in the context of data (images, records) for an AI/ML algorithm is not applicable. The sample sizes would refer to the number of physical devices tested for each bench-top, biocompatibility, and sterilization test. These specific numbers are not provided in this summary.

• Data Provenance: Not applicable in the context of this non-AI/ML device. The "data" comes from laboratory bench testing of physical devices, not from patient-derived data (e.g., medical images). The testing was for a physical medical device (microcatheter).

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

This is not applicable for a physical medical device. Ground truth, in the context of AI/ML, refers to expert-labeled data for training and evaluating algorithms. For this microcatheter, performance is evaluated through objective physical and chemical tests, not human expert interpretation of data.

4. Adjudication Method for the Test Set:

This is not applicable as there is no human review of "data" from the test set for an AI/ML system. The tests are bench-top, objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to a physical medical device (microcatheter), not an AI/ML-driven device or diagnostic tool that would involve human readers interpreting cases.

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

No, this is not applicable. The Soldier Microcatheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For this physical device, "ground truth" doesn't refer to clinical outcomes or expert consensus on patient data. Instead, it refers to:

• Established laboratory standards and validated test methods (e.g., ISO 10993, ASTM F1980) for evaluating physical and chemical properties.
• Engineering specifications and design requirements for the device, against which performance is measured (e.g., burst pressure, flow rate, dimensions).

8. The Sample Size for the Training Set:

This is not applicable. There is no software algorithm or "training set" for a physical microcatheter.

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

This is not applicable as there is no training set for a physical microcatheter.

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The Teleport XT microcatheters are indicated for:

• supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
• exchanging guidewires in the coronary and peripheral vasculature.
• the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

Teleport XT Microcatheter is a single lumen OTW catheter offered in one size (2.1F, distal OD) with working lengths of 90cm, 135cm or 150cm, designed for use in the coronary and peripheral vasculature. The shaft profile gradually changes from 2.8F (0.0370") to 2.1F (0.0280"). The catheter consists of five primary sections: hub, body shaft, proximal section, distal section, and a radiopaque tip. The distal most 60cm of the outer surface is coated with hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014-inch (0.36mm) guidewire.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Teleport XT Microcatheter." This document does not contain information about acceptance criteria and study results for an AI/ML device. Instead, it outlines the regulatory approval process for a physical medical device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document discusses performance data for a microcatheter, which includes physical tests such as:

• Sterilization
• Shelf-Life Performance Testing
• Particulate Evaluation
• Visual Inspection
• Dimension Inspection
• Media Flow Rate
• Simulated Use
• Vacuum Leakage
• Shaft Burst Pressure
• Guidewire Compatibility
• Coating Integrity
• Flexibility and Kinking
• Corrosion Resistance
• Torque Strength
• Tensile
• Radiopacity
• Pouch Integrity
• Pouch Burst
• Seal Strength

The document states: "The Teleport XT microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices." However, it does not detail what those specific acceptance criteria were or provide the reported performance values. It also does not discuss any of the AI/ML specific criteria you requested (sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

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