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The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.

The Silk Road Medical ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a standard rapid exchange (RX) 0.014" Percutaneous Transluminal Angioplasty (PTA) catheter with a proximal single lumen and distal coaxial lumen tubing with a dilatation balloon, and an atraumatic, tapered tip. The proximal luer lock hub allows for connection with a balloon inflation device for inflation with diluted contrast medium. The second lumen in the distal shaft permits the use of an 0.014" guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has two radiopaque marker bands to aid in positioning the balloon in the stenosis, located either 25 or 35 mm apart as indicated on the package label. An external position marker is located 32.5 cm from the distal tip to indicate the relative position of the catheter tip to the guiding catheter/introducer sheath. The total working length of the catheter is 75 cm. The Silk Road Medical ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter will complement the TCAR procedure.

The provided text describes a medical device called the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter and its substantial equivalence submission to the FDA. The document outlines acceptance criteria and the studies conducted to prove the device meets these criteria.

Here's the breakdown of the requested information based on the provided text:

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

The document details various tests performed and states that the device "met all established requirements" and "all tests passed successfully." While specific quantitative acceptance criteria or exact performance values are not explicitly listed in a comparative table within the provided text, the document indicates that the device met the pre-determined acceptance criteria for each test.

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

The text does not specify the sample sizes used for the test sets in any of the biocompatibility, design verification, sterilization, packaging validation, or shelf life studies. It also does not provide information about the country of origin or whether the data was retrospective or prospective, as these were all bench-top and lab-based tests.

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)

This information is not applicable and not provided in the document. The studies conducted (biocompatibility, bench-top engineering tests, sterilization/packaging validation) do not involve expert interpretation or ground truth establishment in the way clinical studies or image analysis algorithms would. The "ground truth" for these tests is based on established scientific and engineering principles, and validated test methods.

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

This information is not applicable and not provided. Adjudication methods are typically relevant for clinical studies or studies involving human readers/interpreters, which is not the nature of the tests described for this device.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. This device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The device is a physical medical device, not an algorithm. Therefore, "standalone" algorithm-only performance is not relevant to this submission.

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

The "ground truth" for the tests performed is based on established scientific principles, consensus standards (e.g., ISO, FDA guidance documents), and engineering specifications. For biocompatibility, it's the biological response to materials; for design verification, it's the physical and mechanical performance characteristics against predefined specifications; for sterilization, it's the efficacy of the sterilization process according to standards. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This information is not applicable and not provided. The development and testing of this physical medical device do not involve "training sets" in the context of machine learning or AI. The design and manufacturing processes are validated against specifications and standards, not "trained" on data.

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

This information is not applicable for the reasons stated in point 8.

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