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Carotid Shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

The Flexcel™ Carotid Shunt is designed to serve as a temporary blood conduit connecting one section of a vessel to a second area of the same vessel. This allows blood to continuously flow to the patient's brain during an endarterectomy procedure. The Flexcel Carotid Shunt is a straight design shunt packaged in 5-unit packages providing a variety of sizes from 8-14 French.

Here's an analysis of the provided text regarding the Flexcel™ Carotid Shunt:

The document is a 510(k) Summary for the Flexcel™ Carotid Shunt, submitted by LeMaitre Vascular, Inc. to the FDA. The core of this submission is to demonstrate substantial equivalence to previously marketed predicate devices, not to prove meeting specific, novel acceptance criteria through a clinical study. Therefore, many of the requested categories about acceptance criteria, detailed study design, and reader performance are not directly applicable or explicitly stated in this type of regulatory document.

However, based on the information provided, here's what can be extracted and inferred:

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

Since this is a 510(k) submission focused on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined performance targets for a clinical study. Instead, the device's performance is demonstrated through bench tests and analyses to show it is comparable to predicate devices. The "reported device performance" is implicitly that it functions as a temporary blood conduit during carotid endarterectomy without introducing new safety or effectiveness concerns compared to the predicates.

2. Sample size 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: Not applicable. The document states "data collected from bench tests and analyses." This indicates laboratory or engineering testing, not a clinical study on patient samples.
• Data Provenance: Not explicitly stated beyond "bench tests and analyses." It would be assumed these tests were conducted by LeMaitre Vascular, Inc., likely at their facilities in the US or Germany.

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)

• Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" refers to engineering specifications, material properties, and functionality under simulated conditions, not expert interpretation of patient data.

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

• Adjudication Method: Not applicable. This concept applies to clinical studies where different experts interpret data. Bench tests would follow engineering and quality control protocols.

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

• MRMC Study: No. This is not an AI/software device. The Flexcel™ Carotid Shunt is a physical medical device (a temporary blood conduit).

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

• Standalone Performance: Not applicable. This is not an AI/software device.

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

• Type of Ground Truth: For the "bench tests and analyses," the ground truth would be based on engineering specifications, material science standards, and functional performance metrics established prior to testing, and compared against the performance of the predicate devices. This is not biological ground truth from patient data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/software device that undergoes machine learning training.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary Conclusion:

The provided document describes a 510(k) submission for a physical medical device, the Flexcel™ Carotid Shunt. The primary method for demonstrating safety and effectiveness is through proving substantial equivalence to existing predicate devices. This is done via bench tests and analyses, not through human-in-the-loop clinical studies, AI performance evaluations, or extensive multi-reader studies with patient data. Therefore, many of the questions related to clinical study design, expert involvement, and AI performance are not relevant to this specific regulatory submission. The "study" proving the device meets the (inferred) acceptance criteria is the undisclosed set of bench tests and analyses that LeMaitre Vascular performed to support their claim of substantial equivalence.

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