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The Penumbra Balloon Guide Catheter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature.

The Penumbra Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque markerband on the distal end and bifurcated Luer hub on the proximal end. A semi-compliant balloon is flush mounted on the distal end. During use, the balloon may be inflated to temporarily occlude blood flow, and the catheter lumen may be used to provide a conduit for passage of vascular devices. The design combines the features of a guide catheter with the features of a semi-compliant balloon catheter.

Materials used in the Penumbra Balloon Guide Catheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.

This is a 510(k) summary for a medical device (Penumbra Balloon Guide Catheter), not a study analyzing AI/ML device performance. Therefore, most of the requested information (acceptance criteria, study design, expert involvement, etc.) typical for AI/ML device evaluations is not present in this document.

The document states that the Penumbra Balloon Guide Catheter is substantially equivalent to a predicate device (Concentric Balloon Guide Catheter, K021899). Substantial equivalence is the primary acceptance criterion in these types of submissions, rather than specific performance metrics against a defined dataset.

Here's what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This document describes a traditional medical device (catheter) submission, not an AI/ML device requiring a test set for performance evaluation against a dataset. The "testing" mentioned refers to engineering and preclinical validation of the physical device.

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

• Not applicable. Ground truth establishment by experts for an AI/ML test set is not part of this device submission.

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

• Not applicable.

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-assisted device.

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

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

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

• Not applicable. The "ground truth" for this type of device is its physical and functional performance according to established engineering and medical device standards, and its equivalence to a predicate device.

8. The sample size for the training set:

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

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

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

Summary of the Study/Testing that Proves the Device Meets Acceptance Criteria:

The document states that "Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications."

The primary "study" for this submission is implicitly the demonstration of substantial equivalence to the predicate Concentric Balloon Guide Catheter (K021899). This means that Penumbra presented data (likely from the aforementioned bench, in vitro, and in vivo tests) to show that their device is as safe and effective as the predicate device for its intended use. The FDA's letter confirms that they have reviewed the submission and determined that the device is substantially equivalent.

Without the specific test reports from the bench, in vitro, and in vivo testing, the detailed methodology and results of these tests cannot be described further. However, the FDA's clearance indicates that these tests were deemed sufficient to support the claim of substantial equivalence.

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