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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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SINC Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices, and provide a conduit for delivery of saline solutions or diagnostic/ therapeutics agents.

The SINC™ (Selective Interventional Navigation Catheter) Support Catheters are single lumen catheters designed to access peripheral vasculature. These catheters are available in a variety of lengths and offer a side port. Each configuration has a braided support matrix and hydrophilic coating on the distal segment of the catheter. The distal tip is clearly distinguished by a radiopaque gold coated tip.

The SINC Support Catheters will also allow for exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

The provided text is a 510(k) summary for the Reflow Medical SINC Support Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not include information about a study proving the device meets acceptance criteria related to a standalone AI algorithm's performance, human-in-the-loop performance, or the nuances of AI model development (training/test sets, ground truth establishment, expert adjudication).

The document focuses on the physical and mechanical performance of the catheter itself, demonstrating substantial equivalence to a predicate device through non-clinical laboratory testing. The types of tests mentioned are:

• Simulated Use Testing
• Dimensional Verification
• Leak Testing
• Bond Integrity
• Component Integrity
• Corrosion Testing
• Kink Resistance
• Torque Testing
• Particulate
• Catheter Flow Rate and Burst Testing
• Lubricity Characterization
• Packaging Testing
• Design Validation

These tests are standard for medical devices like catheters to ensure their mechanical safety and functionality, not for AI/ML performance.

Therefore, I cannot provide accurate answers to most of your questions as they pertain to an AI/ML device study, which is not described in the given text.

However, I can extract information relevant to the device's mechanical performance to show what "acceptance criteria" and "performance" are mentioned for this type of device:

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

The document states: "The SINC™ Support Catheter met all specified criteria and did not raise new safety and performance questions." While specific quantitative acceptance criteria and reported values for each test (e.g., "Kink Resistance: Passed 1N force without kinking") are not detailed in this summary, the general statement indicates successful performance against pre-defined criteria for each test listed.

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 applicable to the non-clinical, mechanical testing described. The "test set" here refers to the physical units of the SINC Support Catheter used for the various lab tests (e.g., a certain number of catheters were subjected to torque testing, burst testing, etc.). The document does not specify the number of units tested for each category, nor is "data provenance" (country/retrospective/prospective) relevant to lab-based mechanical tests.

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 is not applicable. "Ground truth" in this context refers to the successful completion or failure of mechanical tests according to engineering specifications, not expert interpretation of medical images or patient outcomes. The "experts" would be the engineers and technicians conducting and evaluating the specified physical/mechanical tests according to established international standards (like ISO 10555-1, referenced in the document). Their qualifications would be in engineering, materials science, or related fields, not medical imaging.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus on medical image interpretations or clinical outcomes, typically when ground truth is subjective or challenging to obtain. For mechanical tests, the results (e.g., pass/fail, measurable physical properties) are typically objective and determined by the test protocol itself.

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

Not applicable. No MRMC study was performed as this is a medical device (catheter), not an AI-assisted diagnostic tool.

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

Not applicable. No standalone algorithm performance was assessed as this is a medical device (catheter), not an AI algorithm.

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

For the mechanical tests listed, the "ground truth" is defined by the pass/fail criteria of the specified engineering and performance tests, often based on international standards (like ISO 10555-1 mentioned in the document) and the device's design specifications. For example, a "kink resistance" test would have an objective threshold for what constitutes a "kink" and the maximum force the catheter must withstand without kinking.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the machine learning sense. The "training" for such a device involves its design, manufacturing processes, and quality control.

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

Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (a catheter) and its mechanical performance testing. It does not describe an AI/ML device or a study involving AI performance metrics or human-AI interaction.

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Cora Catheters 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 delivery of saline solutions or diagnostic contrast.

The coraForce and coraFlex Support Catheters are devices intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature. The device consists of a support catheter body with a luer end and a polymer tip (coraFlex) or metallic tip (coraForce). The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it relates to performance metrics like sensitivity, specificity, or F1-score which are typically found in AI/ML device studies. The document describes a medical device called "coraForce and coraFlex Support Catheters" and its substantial equivalence to predicate devices, focusing on technological characteristics and bench testing.

Therefore, I cannot provide the requested table or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies.

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The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided text is a 510(k) summary for the ReFlow Medical, Inc. Wingman 14C Crossing Catheter. It describes the device, its intended use, and comparison to a predicate device, as well as a list of performance tests conducted.

However, the document does not contain the kind of information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details about a multi-reader multi-case (MRMC) study for an AI/device. The device described here is a physical medical catheter, not an AI-powered diagnostic device.

Therefore, I cannot fulfill the request using only the provided text. The questions posed are specifically for a study that proves an AI medical device meets acceptance criteria, which this document does not describe.

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The Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman 35 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you requested.

Here's why:

• This document is an FDA 510(k) clearance letter and its summary. It primarily focuses on demonstrating "substantial equivalence" of a new device (Wingman 35 Crossing Catheter) to a previously cleared predicate device.
• The "Performance Data" section (VII) lists categories of tests but explicitly states: "The Wingman 35 Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 35 Crossing Catheter was found to be substantially equivalent to the predicate device." It does not provide details about specific acceptance criteria or the numerical results of these tests.
• The document is about a mechanical catheter, not an AI/ML-driven device. Therefore, concepts like "AI assistance," "human readers," "ground truth," "training set," "test set," "number of experts," and "adjudication methods" as they pertain to AI development and validation are irrelevant to this specific device and are not mentioned in the text.

The information you are asking for (acceptance criteria and study details with respect to AI/ML performance) would typically be found in a more detailed clinical study report or a specific section of a regulatory submission for an AI/ML medical device, not a 510(k) summary for a mechanical catheter.

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The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided document is a 510(k) summary for the speX Support Catheter, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI-driven device meets specific acceptance criteria.

As such, the information requested in the prompt, which is typically relevant for AI/ML medical devices, is largely absent from this document. The document describes a physical medical device (a support catheter), and the "performance data" refers to physical and mechanical tests of the catheter, not the performance of an algorithm.

Therefore, I cannot provide most of the requested information based on the provided text.

Here is what I can extract:

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

Based on the document, specific numerical acceptance criteria and reported device performance are not explicitly detailed in a table format. The document states:

• "The modified speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
• "Based on the performance testing the modified speX Support Catheter was found to be substantially equivalent to the predicate device."

The types of tests performed were:

• Simulated Use Testing
• Component/Assembly Integrity Testing
• Corrosion Resistance Testing
• Lubricity Testing

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

• This information is not available in the provided text, as the study involves physical device testing, not AI data analysis.

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/not available, as the study pertains to physical device performance and not diagnostic or interpretive tasks requiring expert ground truth in the context of AI.

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

• This information is not applicable/not available for this type of physical device 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:

• This information is not applicable. This document describes a physical medical device, not an AI system that assists human readers.

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

• This information is not applicable. This document describes a physical medical device, not an algorithm.

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

• This information is not applicable. For physical device testing, "ground truth" would typically refer to established engineering specifications, mechanical properties, and functional requirements, as opposed to medical diagnoses.

8. The sample size for the training set:

• This information is not applicable/not available as this is a physical medical device, not an AI model requiring a training set.

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

• This information is not applicable/not available as this is a physical medical device, not an AI model.

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The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents. The Wingman 14C Crossing Catheter has an OD of ~ 0.035" with an ID compatible with 0.014" guidewires. The Wingman 14C Crossing Catheter is available in 90cm, 135cm and 150cm lengths.

The provided text describes a 510(k) premarket notification for a medical device called the "Wingman 14C Crossing Catheter." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria in a clinical or analytical setting.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details about training sets.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size.
5. Whether a standalone (algorithm-only) performance was done.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
7. How the ground truth for training or test sets was established.

The "Performance Data" section (Page 5) lists various types of engineering and materials performance testing conducted (e.g., Sterilization Validation, Biocompatibility Testing, Simulated Use Testing, Component/Assembly Integrity Testing, Corrosion Resistance Testing, Lubricity Testing). It states that the device "met all specified criteria" for these tests, implying that there were pre-defined acceptance criteria for these engineering and material properties. However, the document does not provide the specific numerical acceptance criteria or the reported results for each of these tests.

In summary, this document is a regulatory submission demonstrating substantial equivalence based on technological characteristics and engineering/material testing, not a clinical study report with detailed performance metrics and ground truth establishment as would be common for AI/ML or diagnostic devices.

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The Wingman 18 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

The Wingman 18 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

This document is a 510(k) Premarket Notification from the FDA regarding the "Wingman 18 Crossing Catheter." It focuses on demonstrating substantial equivalence to predicate devices, not on proving new clinical effectiveness or safety in a comprehensive standalone study like an AI algorithm would require.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those pertaining to AI algorithms, clinical trials with human readers, and detailed ground truth establishment) are not applicable to this type of medical device submission.

Here's an attempt to answer the questions based on the provided document, highlighting where information is not available or not relevant to a 510(k) for a physical medical device like a catheter:

Acceptance Criteria and Device Performance for Wingman 18 Crossing Catheter (K160848)

As this is a 510(k) submission for a physical medical device (catheter) and not an AI algorithm, the "acceptance criteria" discussed are primarily related to demonstrating substantial equivalence to legally marketed predicate devices through engineering and performance testing, rather than complex clinical outcomes or AI performance metrics.

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

The document states:
"The Wingman 18 Crossing Catheter met all specified criteria and did not raise new safety or performance questions."
"Based on the performance testing the Wingman 18 Crossing Catheter was found to be equivalent to the predicate device."
"The design testing performed for the Wingman 18 Crossing Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices."

However, the specific quantitative acceptance criteria and detailed reported performance metrics are not provided in this summary document. Typically, these would be detailed in the full submission, but only the types of performance data are listed.

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

The document does not specify the sample sizes for the "Particulate Characterization," "Simulated Use," or "Predicate Device Comparison Evaluation."

Regarding data provenance: These are likely laboratory/engineering tests performed by the manufacturer, Reflow Medical, Inc., in the United States, as the company is based in San Clemente, California. The studies are prospective in the sense that they are conducted specifically to support this regulatory submission, testing the device under controlled conditions. This is not clinical data provenance in the sense of patient cohorts.

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. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or AI algorithms that interpret medical images/data. For a physical device like a catheter, performance is evaluated through engineering bench testing and simulated use, not through expert interpretation of clinical "truths."

4. Adjudication method for the test set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials, especially for medical imaging or AI studies, where human expert disagreement on interpretation needs a defined resolution process. For physical device performance testing, predefined engineering specifications and measurement techniques are used.

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, an MRMC comparative effectiveness study was not conducted and is not applicable for this device. This type of study is specifically designed for diagnostic aids, particularly AI algorithms, to measure their impact on human reader performance. The Wingman 18 Crossing Catheter is a physical interventional tool, not a diagnostic aid or AI.

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

No, a standalone algorithm performance study was not done and is not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance relies on pre-defined engineering specifications, material properties, and functional benchmarks established through testing and comparison with predicate devices. This involves:

• Engineering specifications: Meeting dimensions, material strength, radiopacity, and other design parameters.
• Performance metrics: Demonstrating successful navigation, guidewire support, fluid delivery capability, and resistance to kinking or damage during simulated use.
• Predicate device equivalence: Showing that its performance is comparable to an established, legally marketed device for the same intended use.

It is not based on expert consensus, pathology, or clinical outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set

This concept is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product, not an AI, so there is no training set.

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

This concept is not applicable as there is no training set for this physical device.

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