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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® 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® Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.

This document describes a 510(k) premarket notification for the "Destination® Renal Guiding Sheath." This is a medical device, and the evaluation focuses on its substantial equivalence to a predicate device, not on complex AI performance metrics. Therefore, many of the requested fields are not applicable in this context.

Here's the breakdown of what can be extracted and what cannot:

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

For a traditional medical device like a guiding sheath, "acceptance criteria" are typically related to meeting established performance standards (e.g., sterilization, biocompatibility, mechanical integrity) and demonstrating equivalence to a predicate device. Performance is shown through bench and vessel model testing, not statistical metrics like sensitivity/specificity for disease detection.

Studies that Prove the Device Meets Acceptance Criteria:

The document states:

• "The performance of the Destination® Renal Guiding Sheath is substantially equivalent to the performance of the unmodified Renal Guiding Sheath. The equivalence was shown through bench and vessel model testing."
• "Sterilization conditions have been validated in accordance with EN ISO 11135-1..."
• "Blood contacting materials were tested in accordance with the test recommendations in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993..."

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

This information is not provided in the summary. For a medical device 510(k), especially one comparing physical characteristics to a predicate, specific "test set" sample sizes or data provenance in the way one would describe for an AI/ML study are not typically detailed in this type of summary document. The "bench and vessel model testing" implies laboratory testing rather than human subject data.

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 is not applicable and not provided. The ground truth for device performance in this context would be engineering specifications, physical measurements, and biological compatibility standards, not expert consensus on medical images or diagnoses.

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

This is not applicable and not provided. Adjudication methods are relevant for studies where human interpretation (e.g., of medical images) generates a "ground truth" that needs to be resolved by multiple experts. For physical device performance, this concept doesn't apply.

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

This is not applicable. This device is a physical medical instrument (a guiding sheath), not an AI algorithm or a diagnostic tool that involves human readers interpreting data assisted by AI.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is based on established engineering and biocompatibility standards, and measurable physical properties. For example:

• Sterility: Achieves a measured Sterility Assurance Level (SAL) of 10^-6, verified by laboratory testing according to EN ISO 11135-1.
• Biocompatibility: Meets the requirements outlined in ISO 10993 for limited contact with circulating blood, verified by laboratory testing.
• Physical Performance (e.g., torqueability, pushability, trackability): Assessed through "bench and vessel model testing" against a predicate device. The ground truth here would be engineering metrics and comparison to the predicate's established performance.

8. The sample size for the training set

This is not applicable and not provided. This device does not involve a "training set" in the context of machine learning.

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

This is not applicable and not provided. This device does not involve machine learning or a training set.

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The 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 Renal 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 5 cm. It comes packaged with a dilator, a rotating hemostatic valve (or a detachable hemostatic valve), and a dilator retaining clip.

This document describes a medical device, the "Renal Guiding Sheath," and its submission for FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device, not on AI/algorithm performance. Therefore, many of the requested fields related to AI, ground truth, and expert evaluation are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify sample sizes for each performance test. The data provenance is not mentioned beyond the fact that tests were performed to demonstrate substantial equivalence. It is likely internal testing without country-of-origin specification, and it is implied to be prospective testing (performance evaluations of the new device).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a physical medical instrument, not an AI or diagnostic algorithm that requires expert-established ground truth for its performance evaluation in this context. The performance tests are engineering and biological evaluations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or clinical cases to establish ground truth for AI algorithms. For physical device performance tests, standards and objective measurements are used.

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 document describes a physical medical device, not an AI system. Therefore, no MRMC study or AI assistance effect size is relevant.

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

Not applicable. This is not an algorithm, so standalone performance is not relevant.

7. The Type of Ground Truth Used

For the performance tests:

• Engineering Standards / Objective Measurements: For tests like Penetration, Kink Resistance, Leakage, Tensile Strength, and Tortuous Path / Durability, the "ground truth" would be the successful adherence to pre-defined engineering specifications and measurable performance within acceptable limits, often compared directly to the predicate device's measured performance.
• Validated Standards: For sterilization, the ground truth is established by validation against ANSI / AAMI / ISO 11135-1994 to achieve a specified SAL.
• Biocompatibility Standards: For biocompatibility, the ground truth is conformity with test recommendations in FDA General Program Memorandum #G95-1 (ISO 10993).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is a physical device, not an AI algorithm.

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