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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 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.

Ask a specific question about this device