Search Results

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 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 Modeline Catheter to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen). this device modification increases the outer diameter of the thoracic models from 14 Fr to 16 Fr.

Here's a breakdown of the acceptance criteria and study information for the UnBalloon Non-Occlusion Modeling Catheter, based on the provided text:

Important Note: The provided text is a 510(k) summary and FDA clearance letter for a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical trial or AI model validation study. Therefore, many of the typical acceptance criteria and study details for AI/software-as-a-medical-device (SaMD) are not applicable or not present in this type of submission. The device described is a physical catheter, not an AI model.

Acceptance Criteria and Reported Device Performance

Given that this is a physical medical device and not an AI/software device, the "acceptance criteria" are related to its physical performance, safety, and functional equivalence to a predicate device. There are no explicit, quantifiable acceptance criteria presented in the format often seen for AI model performance (e.g., sensitivity, specificity thresholds). Instead, the document summarizes various tests performed to ensure the device meets its specifications and is substantially equivalent.

Study Details (Applicable to a Physical Medical Device Submission)

1. Sample size used for the test set and the data provenance:

   • The document mentions "Animal testing (ovine study)" as one of the completed tests. However, the specific sample size (number of animals) for this study is not provided.
   • Data provenance for the animal study is "ovine" (sheep), which is a common animal model for cardiovascular devices. It would be considered prospective for the purposes of the animal study itself.
   • For the other listed tests (e.g., dimensional analysis, fatigue), these are typically in-vitro (benchtop) tests, and the "sample size" would refer to the number of devices or components tested. This information is not specified in the summary.

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

   • This question is not applicable as the device is a physical catheter, not an AI/software device that generates outputs requiring expert interpretation to establish ground truth (e.g., image classifications). The "ground truth" for a physical device is its measurable physical properties and performance in specified tests.

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

   • This is not applicable to a physical device submission of this nature. Adjudication methods are typically used for establishing ground truth in human-AI studies or for resolving discrepancies in expert interpretations, neither of which is relevant here.

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:

   • This is not applicable. This device is a physical catheter, not an AI assistance tool for human readers. No MRMC study was performed.

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

   • This is not applicable. This device is a physical catheter, not an algorithm.

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

   • For this physical medical device, the "ground truth" is established by:
     • Physical measurements and engineering specifications: For tests like dimensional analysis, radial outward force, apposition length, and force at break.
     • Standardized test methods/protocols: For tests like freedom from leakage, fatigue and simulated use, interaction with stent graft materials, sterilization, and biocompatibility.
     • Physiological observation/measurement in animal models: For the ovine animal study.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is a physical device, not a machine learning model.

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

   • This is not applicable for the same reason as above.

Ask a specific question about this device