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The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.

The Destination® Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Destination® Guiding Sheath is a 3-layer tubing with a Stainless-Steel coil reinforcement sandwiched between layers of PTFE Teflon and Nylon Pebax, a hemostatic valve at the proximal end, a radiopaque marker near the distal end, and a hydrophilic coating on the distal portion of the tubing of varying lengths based on the product code. The sheath is available in multiple French sizes, useable lengths and distal shape configurations. The Destination® Guiding Sheaths are packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (only available with codes that contain the Tuohy-borst valve).

This is not an AI review. The document is for a medical device called "Destination Guiding Sheath" and pertains to its 510(k) premarket notification to the FDA. The submission seeks to establish substantial equivalence to previously marketed predicate devices, not an AI or algorithm. Therefore, the questions related to AI acceptance criteria, training sets, test sets, and expert adjudication are not applicable to this document.

However, I can provide the available information regarding the device's performance criteria and testing based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The Destination® Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence." Specific numerical acceptance criteria are not detailed in the summary, but the types of tests performed and the general outcome are provided.

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

• Sample Size: Not specified in the provided text for non-clinical performance tests.
• Data Provenance: The tests were conducted internally ("In-house standard") or against FDA guidance documents. The document doesn't specify country of origin for the test data, but the manufacturer is Terumo Medical Corporation with locations in Somerset, NJ and Elkton, MD, suggesting U.S.-based testing or oversight. The studies were non-clinical (laboratory/bench testing).

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

This question is not applicable as the document describes a traditional medical device (catheter introducer), not an AI/ML device that requires expert ground truth for image or data interpretation. Performance was evaluated against engineering standards and regulatory guidelines.

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

Not applicable, as this refers to adjudication for expert-labeled ground truth in AI/ML studies.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for the non-clinical tests was established by predefined engineering specifications, applicable FDA guidance documents, and international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization).

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and thus does not involve a training set.

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

Not applicable, as this is not an AI/ML device and thus does not involve a training set or its ground truth establishment.

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The Destination Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

The Destination® Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Carotid Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (dilator retaining clip is only available with codes containing the touhy-borst valve).

This document is a 510(k) summary for the Destination® Carotid Guiding Sheath, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against predefined acceptance criteria for a novel AI device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI-specific details cannot be extracted from this document.

However, I can extract information relevant to the performance section as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, but the testing involved "bench and cadaver testing." This suggests a mix of laboratory and pre-clinical data. No mention of human clinical data or country of origin.
• Retrospective or Prospective: Not indicated.

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 as this is not a diagnostic AI device requiring expert-established ground truth.

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

• Not applicable. This document describes physical device testing.

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 device is a guiding sheath, not an AI diagnostic tool.

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

• Not applicable. This is not an algorithm. The device "is operated manually or by a manual process."

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

• Not applicable in the typical sense for an AI device. The "ground truth" here would relate to the successful performance of the device in bench and cadaver testing, likely against established engineering and physiological parameters for catheter introducers.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device.

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