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The Pruitt F3-S Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

The Pruitt F3-S Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. The Pruitt F3-S Shunts are multi-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon.

The provided document describes the LeMaitre Vascular Pruitt F3-S Carotid Shunt (K143454) and its substantial equivalence to a predicate device. This is a medical device submission, not a study of an AI algorithm, so many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or do not directly translate. However, I can extract information related to the device's performance testing and acceptance criteria as described in the summary.

Acceptance Criteria and Device Performance for Pruitt F3-S Carotid Shunt

The document focuses on demonstrating substantial equivalence to a predicate device (Pruitt F3 Carotid Shunt K051067) by comparing technological characteristics and performing functional/safety testing. It does not provide explicit numerical acceptance criteria values or specific performance results for each test in a table format, but rather states that the device "meets the product performance requirements of the device specifications."

However, based on the "Summary of Product Testing," we can infer the aspects of performance that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" for a statistical study in the way an AI algorithm might. The testing described is pre-clinical functional and safety testing on the device itself.

• Sample Size: Not explicitly stated for each test, but typically these tests involve a representative sample of devices.
• Data Provenance: The tests are performed by the manufacturer, LeMaitre Vascular, Inc., likely at their facilities in Burlington, MA, USA, as part of their internal verification process. The data is prospective, generated specifically for this submission.

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

This concept is not directly applicable. The "ground truth" for a medical device's functional integrity is established by engineering specifications, recognized industry standards (like ISO 11135-1 for sterilization), and comparison to predicate devices, rather than expert consensus on a diagnostic outcome. The "experts" involved would be the engineers and quality assurance personnel at LeMaitre Vascular.

4. Adjudication Method for the Test Set

Not applicable. This type of testing relies on objective measurements against predefined engineering specifications, not subjective interpretation requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., images) with and without AI assistance. The Pruitt F3-S Carotid Shunt is a physical medical device, not a diagnostic AI algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable, as this is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on engineering specifications, design requirements, and established performance characteristics of the predicate device. For biocompatibility, it's the known biocompatibility profile of the materials used in the predicate device. For sterilization, it's compliance with an international standard (ANSI/AAMI/ISO 11135-1:2007).

8. The Sample Size for the Training Set

Not applicable, as this is not an AI algorithm requiring a training set.

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

Not applicable, as this is not an AI algorithm requiring a training set.

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