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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

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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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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 Modeling Catheter consists of 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 medical device, the "UnBalloon Non-Occlusive Modeling Catheter," and its premarket notification (510(k) summary). It focuses on demonstrating the device's substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria for performance as an AI/ML product.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to performance testing of AI/ML devices.

However, I can extract information related to the device's functional performance and safety as described in the "Summary of Product Testing" and "Summary of OUS Post Market Surveillance" sections.

Here's the breakdown of what can be populated based on the provided text:

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

The document does not explicitly state "acceptance criteria" with numerical targets in the same way an AI/ML device would have for metrics like sensitivity, specificity, etc. Instead, it lists various assessments performed and their outcomes, indicating successful performance or minimal issues.

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: 13 cases (OUS Post Market Surveillance).
• Data Provenance: Retrospective collection of data from 13 cases attended by LeMaitre Vascular in Brazil and the European Union. Dates: June 14, 2011 to August 16, 2011.

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 information is not provided. The "Summary of OUS Post Market Surveillance" describes direct observation and recording of outcomes by LeMaitre Vascular staff during cases rather than a formal expert-adjudicated ground truth process. The clinicians performing the procedures are the "evaluative experts" in a practical sense, but their specific qualifications are not detailed.

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

Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies, which is not the nature of this device's evaluation. The data seems to be collected directly from the surgical cases by LeMaitre Vascular personnel.

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 not an AI/ML device, and no MRMC study was conducted. The evaluation is a direct assessment of the device's performance in clinical use, and a comparison to human readers with/without AI assistance is irrelevant.

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

Not applicable. This is not an AI/ML device.

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

For the "OUS Post Market Surveillance," the "ground truth" is operational and clinical outcomes observed directly during surgical procedures, reported by LeMaitre Vascular personnel attending the cases. This includes observations on technical success, device performance (e.g., resheathing, non-occlusion), and adverse events, as well as subjective assessments like "radiopacity" and "appropriate modeling force."

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable. This is not an AI/ML device.

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