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The Wingman Extendable Tip 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 exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman Extendable Tip Support 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. The Wingman Extendable Tip Support Catheter product line is being extended to add a .035 diameter device configuration.

The provided text describes a medical device, the "Wingman Extendable Tip Support Catheter," and its 510(k) premarket notification for substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria related to AI or machine learning performance.

The document is a regulatory submission for a physical medical device (a catheter), not a software or AI/ML-driven device. Therefore, the questions regarding ground truth, expert adjudication, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance are not applicable to this document. The "performance data" section refers to engineering tests on the physical catheter, not AI performance metrics.

Here's the breakdown based on the provided text, indicating what information is not available for an AI/ML context:

1. Table of acceptance criteria and reported device performance:

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

• Not applicable for AI/ML. The document states "All testing was performed on test units representative of finished devices." This refers to physical catheter units, not a dataset for an AI model.

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

• Not applicable. There is no "ground truth" in the context of AI/ML for this physical device.

4. Adjudication method for the test set:

• Not applicable. This relates to AI/ML ground truth establishment.

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 medical device, not an AI-driven one.

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

• Not applicable. This refers to AI algorithm performance.

7. The type of ground truth used:

• Not applicable. There is no "ground truth" as it pertains to AI/ML for this device. The "truth" for the physical device tests would be conformance to engineering specifications and performance as intended.

8. The sample size for the training set:

• Not applicable. This refers to AI model training.

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

• Not applicable. This refers to AI model training.

Summary regarding the provided text's limitations for your request:

The provided document is a 510(k) clearance letter for a physical medical device (a catheter). It details the regulatory approval process based on substantial equivalence to a predicate device and outlines various engineering and biocompatibility tests performed on the physical product.

It does not involve any AI or machine learning components, and therefore, all questions related to acceptance criteria, study design, ground truth establishment, or performance metrics for an AI/ML device are not present and cannot be inferred from this document.

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The Wingman Extendable Tip 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 exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman Extendable Tip Support 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.

The provided text describes a 510(k) summary for the ReFlow Medical Wingman Extendable Tip Support Catheter. It outlines the device's characteristics, intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size for each test or the overall test set. The data provenance is not explicitly mentioned but can be inferred as originating from internal testing conducted by ReFlow Medical, a US-based company, as part of their 510(k) submission to the FDA. The testing is prospective as it's for a new or modified device to demonstrate performance.

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

This information is not applicable or provided in the context of this device. The tests performed are engineering and material science-based, not clinical studies requiring expert interpretation of medical images or data for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable or provided for the type of engineering and material performance tests described. Adjudication methods are typically relevant for clinical studies with subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of an AI system on human reader performance, which is not relevant to the physical performance testing of a catheter.

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

No, a standalone performance study was not done. This device is a physical medical device (catheter), not an AI algorithm. The performance evaluation is based on its physical properties and function.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed is the pre-defined acceptance criteria or specifications for each engineering and material test (e.g., a specific tensile strength value, acceptable pressure resistance, etc.). The device's performance was compared directly against these established criteria.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is. The device's design and manufacturing likely involved iterative development and testing, but not in the context of machine learning training data.

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

This information is not applicable or provided as there is no "training set" in the context of this device's development and testing. The "ground truth" for the design and performance specifications would have been established through engineering principles, regulatory requirements, and industry standards for similar medical devices.

Ask a specific question about this device

The Wingman Extendable Tip 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 exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman Extendable Tip Support 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.

The provided text describes a 510(k) summary for the Wingman Extendable Tip Support Catheter, focusing on demonstrating substantial equivalence to a predicate device. It details the device's characteristics and the performance testing conducted.

Here's an analysis of the requested information based on the provided text:

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

The document lists several tests conducted and states that the updated device "met all specified criteria." However, specific numerical acceptance criteria (e.g., minimum tensile strength value, maximum torque value, cytotoxicity limits, etc.) are not explicitly provided in this document. The table below represents the tests performed and the general performance statement provided.

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

The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests conducted. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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 section is not applicable to the provided document. The tests performed are related to the physical and biological characteristics of a medical device (catheter), not to diagnostic image interpretation or expert-driven clinical assessment where ground truth would be established by human experts.

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

This section is not applicable. The type of testing performed (simulated use, tensile strength, biocompatibility, etc.) does not involve adjudication by multiple experts in the sense of clinical decision-making.

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 section is not applicable. The document describes the technical and biological testing of a physical medical device (catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was conducted.

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

This section is not applicable. The device is a physical catheter, not an algorithm, so standalone algorithm performance is not relevant.

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

For the performance tests described (e.g., tensile strength, torque, biocompatibility), the "ground truth" or reference values are typically established by recognized industry standards, internal design specifications, and regulatory requirements (e.g., ISO standards for medical devices, ASTM standards for material properties, or specific FDA guidance documents for biocompatibility). The document implies that these tests were conducted against such "specified criteria." It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This section is not applicable. The device is a physical catheter, not a machine learning model, so there is no "training set."

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

The Wingman Extendable Tip 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 exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman Extendable Tip Support 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.

The provided text describes the Wingman Extendable Tip Support Catheter and its substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria, device performance metrics, detailed study designs, or ground truth establishment relevant to AI/ML device evaluation.

Instead, the document focuses on the regulatory submission for a medical device (a catheter) and aims to demonstrate its substantial equivalence to existing legally marketed predicate devices, which is a different evaluation paradigm than that for AI/ML-driven diagnostic or assistive tools.

Therefore, most of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance for Wingman Extendable Tip Support Catheter

Unavailable Information (Not present in the provided text):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "comparative simulated use testing" and "all necessary verification and validation testing" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data used.
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): This is not relevant to a medical device (catheter) substantial equivalence submission, which relies on engineering and performance testing rather than expert-labeled image data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device submission.
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 device is not an AI/ML diagnostic or assistive tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical catheter, "ground truth" would relate to its physical properties, mechanical performance, and safety in simulated use, not diagnostic outcomes based on expert consensus or pathology. The text implies performance against engineering specifications and comparison to predicate device performance.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable for the same reason as above.

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