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The Pruitt F3 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 Carotid Shunt is used in patients with carotid artery disease in instances where removal of vascular occlusions is the therapeutic objective. The Pruitt F3 Carotid Shunt is employed in Carotid Endarterectomy (CEA), where the shunt is used as a short-term conduit for blood flow between the common carotid and the internal carotid arteries. The Pruitt F3 Shunt is provided sterile for single use, and is provided with two 3 ml syringes used to inflate the balloons (accessory syringes have been previously cleared in K051067).

The Pruitt F3 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 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 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 K182916 document for the Pruitt F3 Carotid Shunt is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.

The document primarily describes bench test data for engineering parameters, not clinical performance metrics tied to specific acceptance criteria.

Here's what can be extracted, and what is explicitly not available:

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

• Not Available directly in the provided text. The document lists "Bench Test Data" items like "Main Lumen Flow Test," "Inflated Common Balloon Diameter," "Deflation Time," etc. However, it does not provide the specific acceptance criteria (e.g., "Deflation Time shall be < X seconds") nor the reported device performance values against these criteria. It only states that these tests were performed to support substantial equivalence.

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

• Not Available. The document refers to "engineering studies" and "bench test data" but does not specify sample sizes for these tests or the provenance of any data (e.g., if any clinical data was indirectly used, which it doesn't appear to be for performance metrics).

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 Available. This device is a mechanical shunt, and its performance is evaluated through engineering bench tests, not clinical image interpretation or diagnosis that would require expert ground truth.

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

• Not Applicable / Not Available. Similar to point 3, adjudication methods are relevant for subjective assessments, typically in clinical studies involving human interpretation. Bench tests for mechanical devices do not use such methods.

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 diagnostic device. It is a physical medical device (carotid shunt). MRMC studies are not relevant for this product.

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

• Not Applicable. This is not an algorithm-based device.

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

• Not Applicable. For the bench tests performed, "ground truth" would be established by direct measurement against engineering specifications or known physical properties, not clinical outcomes or expert consensus.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary, the provided K182916 document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and bench test data for a physical medical device. It does not provide the type of detailed performance criteria and study results that would be expected for an AI/CADe device or a device requiring extensive clinical outcome data for a PMA.

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

The Pruitt F3-S Polyurethane 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. 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 Polyurethane 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 Pruitt F3-S Polyurethane Carotid Shunt is not made of natural rubber latex.

This document is a 510(k) premarket notification for a medical device (Pruitt F3-S Polyurethane Carotid Shunt) and does not contain information about the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted.

The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This involves comparing the new device's technological characteristics, indications for use, and performance data (e.g., sterilization, biocompatibility, functional testing) to those of the predicate device. The functional testing described is for the physical device itself (shunts and balloons), not an AI algorithm.

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