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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 Protége™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20 - 150 mm) and diameters (6 - 12 mm). The stent is electropolished. The stent is premounted on a 6 or 7 Fr delivery catheter 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.

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

The FDA clearance is based on the device being substantially equivalent to a predicate device already on the market, not on new clinical trial data demonstrating performance against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided text. The document primarily focuses on:

• Device Identification: Product name, common name, class, submitter information.
• Intended Use: Palliative treatment of malignant neoplasms in the biliary tree.
• Device Description: Self-expanding nitinol stent, delivery catheter, "StarPort Delivery Technology" system.
• Modification: Increased radiopacity compared to a previously marketed version of the same device.
• Substantial Equivalence: The primary basis for clearance, stating it is substantially equivalent to the currently marketed Protégé™ stent in intended use, materials, technological characteristics, and performance.
• FDA Conditions: Specific labeling requirements regarding the limitation of use to the biliary system and the unestablished safety/effectiveness in the vascular system.

There is no mention of a study with specific performance metrics, sample sizes, expert ground truth establishment, or comparative effectiveness studies with human readers.

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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 - 80 mm) and diameters (6 - 12 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" 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.

The provided document is a 510(k) Premarket Notification Summary for a medical device, the Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication). It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and some regulatory aspects. This document does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way a clinical trial or performance study report would.

The document states:

"The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is substantially equivalent to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K012066) in intended use, materials, technological characteristics and performance. Stent lengths > 80 mm have been added to further expand the product offering."

This indicates that the manufacturer is claiming equivalence to an already approved device rather than presenting a performance study for this specific modified device against new, defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth cannot be extracted from this summary.

Here's what can be inferred or explicitly stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Reasoning: The summary does not provide specific quantitative acceptance criteria (e.g., success rates, complication rates, patency rates) for the modified stent or a detailed performance report. The entire premise of this 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device rather than fulfilling new, specific performance criteria through a dedicated study.

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

• Sample Size: Not applicable / Not mentioned. This document does not describe a clinical performance study with a test set.
• Data Provenance: Not applicable / Not mentioned. As there's no clinical performance study detailed, there's no data provenance information.

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

• Not applicable / Not mentioned. No clinical performance study is described with a test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable / Not mentioned. No clinical performance study is described with a test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect size of human readers with AI vs. without AI assistance: Not applicable. This device is a physical medical device (stent), not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Not applicable. This device is a physical medical device (stent), not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable / Not mentioned. No clinical performance study requiring ground truth is described. The basis for approval is substantial equivalence to a predicate device.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. This document does not describe a machine learning algorithm or a training set.

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

• Not applicable / Not mentioned. This document does not describe a machine learning algorithm or a training set requiring ground truth.

Conclusion:

The provided 510(k) Summary pertains to a physical medical device (a biliary stent) and focuses on demonstrating "substantial equivalence" to a previously cleared product. It does not contain information about a dedicated performance study with specific acceptance criteria, test sets, ground truth establishment, or expert involvement as would be found in a clinical trial report for an AI/diagnostic device. The primary "proof" of meeting safety and effectiveness for this submission is its likeness to the predicate device.

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The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.

The IntraCoil Stent is a self-expanding nickel-titanium (Nitinol) coil premounted on a delivery catheter. The stent is provided in diameters 4 to 8 mm, and lengths of 40 and 60 mm. The stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms. Upon deployment the stent expands to conform to the bronchial lumen surface.

The provided text is a 510(k) premarket notification letter for a medical device called the "IntraCoil® Peripheral Stent." It details the device's classification, indications for use, and a summary. However, this document does not contain the specific information needed to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document states:

• Device Name: IntraCoil® Peripheral Stent
• Indication For Use: The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.
• Regulatory Class: II, Product Code: JCT, Regulation Number: 21 CFR 878.3720 (Tracheal prosthesis)
• Substantial Equivalence: Claimed to the IntraCoil® Self-expanding Peripheral Stent, K990221/K001257.
• Modification Covered by this 510(k): Addition of the 8 x 60 mm stent.
• Testing Mentioned: "A subset of the in vitro performance tests conducted for K990221/K001257, and relevant to the modification, were repeated for design verification and product validation."

This brief mention of "in vitro performance tests" is the only reference to testing. There is no detailed description of:

1. Acceptance criteria and reported device performance table: Not present.
2. Sample size, data provenance (test set): Not present. The "subset of in vitro performance tests" implies bench testing, not a clinical study with patients.
3. Number/qualifications of experts for ground truth (test set): Not applicable as it's not a clinical study based on expert interpretation.
4. Adjudication method (test set): Not applicable.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable as it's not a clinical study requiring ground truth derived from patients/images. "In vitro performance tests" likely refer to engineering measurements and material properties.
8. Sample size for training set: Not applicable as this is a physical medical device, not an AI algorithm.
9. How ground truth for training set was established: Not applicable.

In summary, the provided document is a regulatory approval letter and a 510(k) summary for a physical medical device. It attests to substantial equivalence based on prior approvals and in vitro (bench) testing, but it does not contain the kind of detailed study information (especially clinical study details, human reader performance, or AI algorithm validation) that your questions are asking for.

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The IntraStent® Mega™ LD (Large Diameter) Stent - Biliary Indication and the IntraStent® Max™ LD (Large Diameter) Stent - Biliary Indication are intended as a palliative treatment of malignant neoplasms in the biliary tree.

The IntraStent Mega and Max LD Stents are balloon expandable stainless steel stents with an open lattice design. The device is provided unmounted, to be manually crimped onto a noncompliant PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

Medical Device: IntraStent Mega LD and IntraStent Max LD Stents

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify any sample sizes for a human-based test set or any clinical data provenance. The study described is entirely based on bench testing of the devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was a bench test study, not a clinical study involving experts establishing ground truth from patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device modifications and bench testing for substantial equivalence, not clinical effectiveness studies comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical implant (biliary stent), not a software algorithm or AI. The performance reviewed is mechanical/physical, not algorithmic.

7. Type of Ground Truth Used

The "ground truth" for this submission was the performance characteristics, materials, indication for use, and technological characteristics of the predicate devices (IntraStent™ Stent, K991929, and IntraStent DoubleStrut LD, K993904). The modified devices were compared against these established characteristics of the legally marketed predicate devices to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This submission concerns physical medical devices, not an AI or algorithm that would require a training set.

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

Not applicable. There was no training set in the context of an AI or algorithm.

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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 - 80 mm) and diameters (6 - 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-the-wire delivery catheter designed promountou on an over of Ipon 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 (Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology for Biliary Indication) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically found for an AI or diagnostic device.

This document describes a stent, which is a physical implant used for palliative treatment of malignant neoplasms in the biliary tree. The 510(k) process for such a device focuses on demonstrating substantial equivalence to a previously marketed device, rather than proving performance against specific acceptance criteria for an AI algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily discusses:

• Device Description: What the stent is, its materials, sizes, and delivery system.
• Intended Use: Palliative treatment of malignant neoplasms in the biliary tree.
• Substantial Equivalence: Claims that the modified device is substantially equivalent to previously marketed versions with the addition of a 12mm stent diameter.
• Regulatory Information: Classification, regulation number, product code, and specific labeling limitations imposed by the FDA (e.g., limitation on vascular use and prominent display of biliary indication).

There is no mention of an AI algorithm, diagnostic performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

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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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Ask a specific question about this device