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The steerable guiding sheath, model Adelante Destino is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Do not use this device for neural placements.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use.

There is no modification to the device itself. The Adelante Destino Steerable Guiding Sheath has been cleared in K120459 and will remain intact and no modification to product labels.

This 510(k) summary describes a modification to the Indications for Use (IFU) statement for the Adelante Destino Steerable Guiding Sheath (K122960). The submission explicitly states that there was no change in the device itself or its method of use. Therefore, the information typically associated with acceptance criteria and a study proving a device meets these criteria (such as performance metrics, sample sizes, ground truth establishment, or clinical study designs) is not applicable in this context.

The summary focuses on demonstrating substantial equivalence to predicate devices for the expanded indications, rather than proving performance against specific acceptance criteria through a study.

Here's a breakdown of why many of your requested points are not present in this document:

• No change in device design or performance: The core of this 510(k) is an administrative change to the IFU, not a hardware or software modification that would necessitate new performance testing.
• Focus on substantial equivalence to predicates: The justification for the expanded indications relies on the similarity of the proposed uses to existing cleared predicate devices, implying that the device's inherent performance characteristics, established in its original clearance (K120459), are sufficient for the broader indications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as this information is not part of this specific 510(k) submission.

Summary of available information based on your request:

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

   • Not applicable. This 510(k) is for an expanded Indications for Use statement for an existing, unmodified device. There are no specific new acceptance criteria or reported performance data presented for this submission, as the device's performance was presumably established during its original clearance (K120459). The rationale for the expanded IFU is based on comparison to predicate devices for similar indications.

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

   • Not applicable. No new test set data or clinical studies were conducted for this IFU modification.

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. No new ground truth establishment was performed, as no new clinical data was generated for this submission.

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

   • Not applicable. No test set or clinical study was conducted.

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 steerable guiding sheath, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device or this type of submission.

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

   • Not applicable. This is a hardware device, not an algorithm.

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

   • Not applicable. No new ground truth was established for this submission.

8. The sample size for the training set:

   • Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."

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

   • Not applicable. As above, no training set for a machine learning model is relevant here.

In summary, this 510(k) submission is solely focused on expanding the labeled indications for use of an already cleared and unmodified device, based on substantial equivalence to predicate devices with similar, broader indications. It does not contain information about new performance studies or acceptance criteria.

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The steerable guiding sheath, model Adelante Destino is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

The steerable guiding sheath, model Adelante® Destino, is designed to assist with the introduction of intravascular devices into the heart using a steerable feature to provide better maneuverability and easier access to hard-to-reach places in the heart. On the steerable handle there is a side port for aspiration and flushing. The guiding sheath comprises of: shaft, steerable handle and side port. The dilator is included with each sheath.

The provided text describes a 510(k) submission for the Adelante® Destino steerable guiding sheath. This document focuses on demonstrating substantial equivalence to predicate devices through functional and performance testing, rather than a clinical study evaluating AI performance or human reader improvement. Therefore, many of the requested points, such as AI-specific sample sizes, expert qualifications for ground truth in AI, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

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

• The document does not explicitly state the sample sizes used for each functional and performance test.
• The data provenance is not specified beyond indicating "Functional and performance testing was conducted." This implies in-house laboratory testing, not human subject data.

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

• Not applicable. The ground truth for these engineering performance tests would be established by the test procedures and objective metrics, not by expert consensus in a clinical context.

4. Adjudication method for the test set:

• Not applicable. These are objective engineering tests with defined acceptance criteria.

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 510(k) submission for a medical device (steerable guiding sheath), not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• The ground truth for the functional and performance tests is derived from established engineering and manufacturing specifications and test standards. These are objective, measurable outcomes.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable. This is not an AI algorithm.

In summary: The submission for the Adelante® Destino describes a set of engineering and performance tests to demonstrate the safety and effectiveness of the device against predefined acceptance criteria. All tests passed, supporting the claim of substantial equivalence to predicate devices. The document does not involve AI, human reader studies, or clinical data.

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