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The Adelante® Breezeway Delivery Sheath 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. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.

The provided text is a 510(k) summary for a medical device called the Adelante® Breezeway Delivery Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices for expanded indications. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI performance, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document explicitly states: "This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels."

This means the submission focuses solely on expanding the stated uses for a device that was previously cleared (K101497) and has not undergone any changes itself. Therefore, it relies on the previous clearance and the substantial equivalence to existing predicate devices for the expanded indications, rather than new performance studies with specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document does not describe a study involving performance metrics, sample sizes, expert adjudication, or AI.

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The Adelante Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

The Adelante® Breezeway Delivery Sheath is designed to facilitate the introduction of catheters to any r from heart chambers, including the left atrium via a transseptal puncture. This introducer delivery sheath of the nearl chambere, moldarity the ide port with a three-way stopcock, hemostatic valve, and a dilator. The distal tip of the sheath has side flush portholes. The dilator can be locked on to the sheath. The sheath is supplied in 10 F and two overall lengths, 63 cm and 81 cm, and dilator is supplied in two r rie sheath is oupplied in 10 r and the dilator profile curves are 55, 70, 90, 120 degrees. There are no accessories supplied with this device.

The provided text describes the acceptance criteria and the results of the functional and performance testing for the Adelante® Breezeway Delivery Sheath. However, it does not describe a study involving an AI/Machine Learning device or any human-in-the-loop performance. This document is a 510(k) premarket notification for a medical device (a catheter introducer), not an AI algorithm.

Therefore, many of the requested items related to AI/ML studies are not applicable or cannot be extracted from this text.

Here's a breakdown of the information that can be extracted, along with explanations for the missing AI-specific details:

Acceptance Criteria and Device Performance

Study Details (as applicable to a medical device, not an AI study)

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

   • The document does not specify the sample sizes (number of devices tested) for the functional and performance tests. It mentions "Functional and performance testing was conducted" but provides no numerical details.
   • Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are lab/bench tests on manufactured devices, not clinical data.

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

   • Not applicable. Ground truth, in the context of device performance, is established by adherence to engineering specifications and regulatory standards, not expert consensus on interpretations. The tests appear to be physical and chemical characterizations.

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

   • Not applicable. This concept is for clinical data interpretation, not for objective physical/chemical device testing.

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:

   • No MRMC study was done. This device is a physical medical instrument (a delivery sheath), not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This device is not an algorithm.

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

   • The ground truth for this device's performance tests is based on engineering specifications, manufacturing standards, and regulatory requirements. For example, a bond must withstand a "designated pull force," and residual levels "must be within limits."

7. The sample size for the training set:

   • Not applicable. This is not an AI/Machine Learning device, so there is no "training set."

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

   • Not applicable.

Summary regarding AI/ML aspects:
The provided document is a 510(k) summary for a traditional medical device (Adelante® Breezeway Delivery Sheath) and details its functional and performance testing against established acceptance criteria. It does not involve any AI or Machine Learning components, therefore, questions related to AI studies, training/test sets, expert adjudication, or reader studies are not applicable to the information presented. The "study" referenced is a series of benchtop and lab tests to ensure the device meets its design specifications and safety requirements.

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