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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 Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery.

The Strada™ Carotid Guiding Sheath is designed to perform as an introducer and a guiding sheath. The device is a single-use system that consists of a delivery sheath with hemostatic valve and dilator. Upon removal of the dilator, the delivery sheath provides a pathway for diagnostic and interventional devices into the vasculature. The Strada™ Carotid Guiding Sheath is available in 80 and 90cm lengths. The sheath has an 8F outer diameter and 6F inner diameter. The distal end is straight, has a hydrophilic coating (20cm) and has a radiopaque marker approximately 2.5 mm from the tip. The device is provided sterile and non-pyrogenic.

The provided text describes a 510(k) submission for the Strada™ Carotid Guiding Sheath, focusing on demonstrating substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical testing and comparison to an already cleared device, rather than extensive clinical studies with specific performance metrics for the new device.

Therefore, many of the requested elements pertaining to acceptance criteria and clinical study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, and ground truth for clinical test sets) are not applicable to this 510(k) submission, as it does not present independent clinical performance data for the Strada™ device in the same way a de novo or PMA submission might.

However, I can extract the information that is present and explain why other details are missing based on the nature of a 510(k) submission for this device.

Acceptance Criteria and Device Performance (Based on 510(k) principles):

For a 510(k) submission of this nature, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device through non-clinical testing that confirms the new device meets its own product specifications and intended uses, without raising new questions of safety or effectiveness. The performance is gauged by comparison to the established predicate.

Detailed Study Information (Where applicable/deduced):

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

   • Test Set Sample Size: Not explicitly stated as a single "test set" for performance evaluation in a clinical study. The device underwent "in vitro bench testing," "animal evaluation," "biocompatibility testing," "shelf-life and package testing," and "sterilization validation." The sample sizes for these individual non-clinical tests are not provided in the summary.
   • Data Provenance: The studies are non-clinical (bench, animal, lab-based tests). There is no mention of human clinical data, and thus no country of origin or retrospective/prospective designation for human data.

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

   • Not Applicable: This was a 510(k) submission based on non-clinical testing and substantial equivalence to a predicate device. There was no clinical trial data presented that would require expert adjudication to establish ground truth for a test set.

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

   • Not Applicable: No clinical test set requiring expert adjudication was presented in this summary.

4. 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 a physical medical device (catheter introducer), not an AI-powered diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

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

   • Not Applicable: See point 4. This is not an algorithm or AI device.

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

   • Non-Clinical Standards: The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methodologies, and established safety standards (e.g., ISO standards for biocompatibility, sterility, material properties, mechanical performance). For animal studies, the "ground truth" would be observed physiological responses and outcomes in animal models.

7. The sample size for the training set:

   • Not Applicable: This is a physical medical device. There is no concept of a "training set" in the context of machine learning for this device. The device design and manufacturing processes are "trained" through iterative R&D and testing, but these are not quantified as a "training set" in the common understanding of AI/ML.

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

   • Not Applicable: See point 7.

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

The Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque marker and is hydrophilically coated on the distal 15 cm. It comes packaged with a dilator, a rotating hemostatic valve (Y-connector), and a dilator retaining clip.

The provided document describes the safety and effectiveness of the Carotid Guiding Sheath. It is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial for a novel AI device would.

Therefore, many of the requested fields cannot be directly extracted from this type of regulatory submission. This document describes a medical device (a guiding sheath), not an AI/algorithm-based diagnostic device.

However, I can extract the relevant information regarding performance and equivalence.

Acceptance Criteria and Device Performance Study (as per the 510(k) document for a medical device)

This 510(k) submission demonstrates substantial equivalence to a predicate device, the Super Arrow-Flex Percutaneous Sheath Introducer Set (K924607), manufactured by Arrow International, Inc., by showing that the Carotid Guiding Sheath performs similarly. The acceptance criteria are implicit in matching the performance characteristics of the predicate device for safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For medical devices in a 510(k), "acceptance criteria" are typically defined by meeting established performance benchmarks or demonstrating equivalence to a predicate device's performance. The "reported device performance" is the results of tests aimed at demonstrating this equivalence.

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 explicitly stated. The document refers to "the following tests were performed," implying specific test methods were used for each characteristic, but not a patient or human-subjects test set. These are likely in vitro or bench tests.
• Data Provenance: Not applicable. The tests are device performance tests, not clinical data from patients.

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. This document describes a physical medical device (guiding sheath) and its engineering performance tests, not an AI/algorithm-based diagnostic device requiring expert ground truth for imaging or clinical outcomes. The "ground truth" here is the physical measurement or outcome of the bench test (e.g., whether the device kinks, leaks, or breaks at a certain force).

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

• Not Applicable. This is not a clinical study involving human readers or interpretation of results. Results are likely determined by objective measurements from engineering tests.

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 a physical medical device, 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 a physical medical device.

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

• Bench Test Results / Engineering Standards: The "ground truth" for the performance tests (Penetration, Kink Resistance, Leakage, Tensile Strength, Tortuous Path / Durability) would be the objective measurements obtained during the execution of standardized engineering tests, compared against the performance of the predicate device or established specifications. For biocompatibility and sterilization, the ground truth is compliance with specific international standards (ISO 10993, ISO 11135-1994).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."

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

• Not Applicable. As above, there is no training set for a physical medical device.

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