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The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 70, 80, 80, s premounted on an 80 or 135 cm working length 6F, 0.018" (or 0.014") over-the-wire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not specify a separate "test set" in the context of clinical trials or data-driven performance. The performance evaluation primarily relies on:

• Bench testing for the 6 Fr system.
• Comparison to the previously cleared 7 Fr system (K003040).

Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective) for a distinct clinical test set. The evaluation is based on device characteristics and equivalence to a predicate device.

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

This information is not applicable as the provided document describes a 510(k) submission primarily based on substantial equivalence and bench testing, rather than a clinical study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on device characteristics and substantial equivalence.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical device (a stent and delivery system), not an algorithm or AI software. There is no "standalone" performance for an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance of the predicate device, the 7 Fr Protégé™ stent system (K003040), which was previously cleared by the FDA based on its own evidence of safety and effectiveness. The current submission establishes that the 6 Fr system is substantially equivalent to this predicate.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable for the reasons stated in point 8.

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The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8, 9 and 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.

The provided text is a 510(k) summary for a medical device called "Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication)". It describes a modification to an already marketed device. This kind of document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

It is crucial to understand that 510(k) submissions, especially for devices like stents, typically do not include studies with "acceptance criteria" and "reported device performance" in the way one would describe a novel AI/software medical device (SaMD) study.

For a physical device like a stent, substantial equivalence is usually shown through:

• Bench testing: In-vitro mechanical and material property tests to ensure the modified device performs similarly to the predicate and meets design specifications (e.g., radial force, fatigue resistance, corrosion resistance).
• Biocompatibility testing: To ensure the materials are safe for use in the human body.
• Animal studies: To demonstrate performance in a living system, often focusing on deployment, patency, and tissue response.
• Clinical data (if available and necessary): Sometimes, a 510(k) might reference or provide limited clinical data, but often substantial equivalence for a modification can be established without new clinical trials.

The provided text focuses on the description of the modification and the FDA's determination of substantial equivalence based on the submission. It does not contain the detailed study results of mechanical tests, animal studies, or clinical studies. Therefore, much of the requested information about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC/standalone studies for AI performance is not applicable to this type of document or device.

This document confirms the device is substantially equivalent to a predicate device based on "intended use, materials, technological characteristics and performance." The modifications are described as:

• A stent retainer feature to enhance smoothness of deployment.
• Additional ports for enhanced contrast injection.
• A new 10mm stent diameter.

Based on the provided text, here is why most of your requested information cannot be found or is not directly applicable in the context of an AI/SaMD study:

1. A table of acceptance criteria and the reported device performance: This document does not contain this information in the context of AI performance metrics (e.g., sensitivity, specificity). For a physical stent, acceptance criteria would relate to mechanical properties, material integrity, and functionality, which are not detailed here.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI validation described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI assessment is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 stent, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI context. For a stent, "ground truth" often relates to successful deployment, patency demonstrated through imaging, and clinical outcomes, but these are not detailed in this summary.

8. The sample size for the training set: Not applicable. There is no AI training set.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is for a physical medical device (a stent) seeking 510(k) clearance based on substantial equivalence, not for an AI/software medical device. Therefore, the questions related to AI study design and metrics are not addressed in this document.

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The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8 and 9 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.

The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance. A stent retainer feature has been added to enhance the smoothness of deployment and additional ports for enhanced contrast injection.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and an FDA letter confirming substantial equivalence for a medical device (Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology for biliary indications).

The 510(k) summary states that the modified device "is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance." It does not present specific performance criteria or a study that evaluates them for the modified device. The FDA letter confirms this substantial equivalence based on the provided information, but it also doesn't detail performance studies or criteria.

Therefore, I cannot provide the requested information in the table or the subsequent numbered points based on the input text.

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