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The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.

The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh. This submission modifies the current UnBalloon Non-Occlusive Modeling Catheter by expanding the product family line with additional nitinol mesh cage sizes and catheter lengths.

This medical device is a modeling catheter used in conjunction with self-expanding endoprostheses in large diameter vessels. The provided text contains information about its acceptance criteria and the studies conducted.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify sample sizes for the "Radial outward force," "Apposition Length," or "Simulated Anatomical Use" tests.
The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned. These tests appear to be laboratory-based engineering performance tests rather than clinical studies with patient data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable and therefore not provided in the document. The device verification activities ("Radial outward force," "Apposition Length," "Simulated Anatomical Use") are technical performance evaluations, not diagnostic studies requiring expert-established ground truth.

4. Adjudication Method for Test Set

This information is not applicable and therefore not provided in the document. As mentioned above, the tests are technical performance evaluations.

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

A MRMC comparative effectiveness study was not conducted. This device is a medical instrument (catheter), not a diagnostic or AI-driven imaging tool that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done. The document states, "The following tests have been completed to evaluate the performance of the catheter with shorter cage: Radial outward force, Apposition Length, Simulated Anatomical Use." These tests assess the intrinsic performance of the device without human-in-the-loop performance being a variable.

7. Type of Ground Truth Used

The ground truth used for the performance tests appears to be engineering specifications and established laboratory testing protocols. For biocompatibility, the ground truth is adherence to ISO 10993 guidelines. For sterilization, the ground truth is adherence to ANSVAAMI/ISO 11135-1:2007. These are objective, measurable standards rather than subjective expert consensus, pathology, or outcomes data typically associated with diagnostic algorithms.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This document describes a medical device, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable and therefore not provided, as there is no "training set" for this type of medical device.

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The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of selfexpanding endoprostheses in large diameter vessels.

The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.

The provided text describes a 510(k) summary for the UnBalloon Non-Occlusive Modeling Catheter, focusing on its substantial equivalence to a predicate device and product testing. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical or algorithmic performance. The document is a regulatory submission for premarket notification, demonstrating that the device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested information points, particularly those related to a study proving device performance against acceptance criteria, cannot be extracted from this document, as such a study is not detailed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document mentions "product performance requirements of the device specifications" and lists various tests, but it does not explicitly define specific numerical or qualitative acceptance criteria for each test (e.g., a specific tensile strength value, or a specific duration for fatigue testing without failure). It only states that the device "meets the product performance requirements."

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

Not provided. The document refers to "product characterization and validation" and "verification activities" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

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/Not provided. This type of information is typically relevant for studies involving human interpretation or clinical outcomes, often in the context of AI/ML device evaluations. The reported testing is primarily in-vitro/bench testing for a physical catheter, not an AI diagnostic device.

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

Not applicable/Not provided. As noted above, this is not relevant for the type of product testing described.

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 device is a physical catheter, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical catheter.

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

The "ground truth" for the engineering performance tests (like fatigue, tensile strength, etc.) would be established by engineering specifications, industry standards, and validated testing methodologies against which the device's performance is measured. The document implies compliance with these without detailing them. For biocompatibility, it refers to "ISO 10993 guidelines."

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. See point 8.

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