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The Protégé® RX GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon lo elour porthe constrained stent self-expands to conform to the duct inner luminal surface.

The provided text is a 510(k) Premarket Notification summary and accompanying FDA correspondence for the Protégé® Rx GPS™ Self-Expanding Nitinol Stent (Biliary Indication). This document does not describe a study involving device performance metrics against acceptance criteria in the way typically associated with AI/software devices.

Instead, this is a traditional medical device submission focused on demonstrating substantial equivalence to a previously marketed device. The "device performance" referred to in the document relates to bench testing to support the substantial equivalence claim, rather than clinical performance metrics in a study with a test set, ground truth, or expert review.

Therefore, many of the requested fields cannot be filled based on the provided text, as they pertain to studies typically conducted for AI/ML or diagnostic devices where performance is measured against a ground truth.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent for an AI/ML context:

Analysis of Acceptance Criteria and Device Performance for Protégé® Rx GPS™ Self-Expanding Nitinol Stent

The provided documentation does not detail quantitative acceptance criteria or a specific study proving the device meets particular performance metrics in the way an AI/ML or diagnostic device would. This submission is for a conventional medical device (biliary stent) and relies on demonstrating substantial equivalence to a predicate device, supported by bench testing and similar design/materials.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA letter explicitly notes a limitation: "The safety and effectiveness of this device for use in the vascular system have not been established." This implies the acceptance criteria (and supporting data) were focused solely on the biliary indication.

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

• Sample Size: Not applicable. The document mentions "Performance testing (bench)" but does not specify a sample size for any clinical test set or experimental data in patients. The evaluation is based on substantial equivalence to a predicate device and bench testing for device characteristics.
• Data Provenance: Not applicable for a clinical test set. The bench testing would have been conducted by the manufacturer, ev3 Inc., likely in the USA (where the company is based).

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

• Not applicable. There is no mention of a test set requiring expert-established ground truth. This is a physical device, and its performance evaluation (for substantial equivalence) would involve engineering tests, material characterization, and comparisons to the predicate device, not expert adjudication of diagnostic outcomes.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication in the context of diagnostic or AI performance is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a medical device (stent), not an AI/ML diagnostic or assistive technology for human readers.

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

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

7. The Type of Ground Truth Used

• For the substantial equivalence claim: The "ground truth" implicitly used is the established performance and safety profile of the predicate device (Protégé® GPS™ Self-Expanding Nitinol Stent). The modified device is compared against the characteristics and performance of this existing, legally marketed device.
• For bench testing: The ground truth would be engineering specifications, material standards, and functional requirements for a biliary stent.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device (stent), not an AI/ML algorithm requiring a training set.

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

• Not applicable. No AI/ML training set is involved.

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The Protégé® GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé® GPS™ Self-Expanding Nitinol Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

The Protégé stent is a self-expanding nitimol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.

This is a 510(k) summary for a medical device, the Protégé® GPS™ Self-Expanding Nitinol Stent (Biliary Indication). It describes a modification to an already marketed device, not the initial clearance of a new device requiring extensive clinical trials for effectiveness. Therefore, many of the requested categories related to clinical study design, ground truth, and expert evaluation are not applicable or not detailed in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission is for a modification of an existing device based on substantial equivalence and bench testing, not a de novo clinical trial.
• Data Provenance: Not applicable. The "performance testing (bench)" suggests laboratory-based evaluations, not patient data.

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

• Not applicable. Ground truth from experts is typically established in clinical studies with patient data. This submission focuses on bench testing and substantial equivalence.

4. Adjudication method for the test set

• Not applicable. There is no mention of a test set with human adjudication.

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 medical device (stent) submission, not an AI/software as a medical device (SaMD) submission. No AI component is mentioned.

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

• Not applicable. This is a medical device (stent) submission.

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

• The "ground truth" for this submission is based on bench testing results demonstrating the physical and mechanical performance of the expanded stent sizes (12mm and 14mm) and the existing knowledge of the predicate device's performance, materials, and design. The "substantial equivalence" claim relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an algorithm/AI study.

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

• Not applicable.

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The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.

The X-SIZER System is a single-use, disposable medical device intended for the selective removal of thrombus from blood vessels. The device consists of a 135cm coaxial, dual lumen hydrophilic coated outer catheter shaft connected to a hand-held Control Module. The inner lumen of the catheter is composed of a hollow torque cable encapsulated in a polyamide tube (flexible drive shaft). A helical cutter is contained within the cutter housing located at the distal tip of the catheter. The outer lumen of the catheter is the path in which the excised debris is removed by vacuum. In use, the cutter is rotated at approximately 2,100 pm by the motor, which is powered by a 9-volt alkaline battery. In addition to turning the helical cutter, the inner lumen provides the space through which a coronary guidewire is placed. The hand-held Control Module contains the motor, battery, circuitry, indicators, and various valves and manifolds for the vacuum removal of thrombotic debris. The X-SIZER System is available in the 1.5mm and 2.0mm diameter models.

The provided document describes the X-SIZER® Catheter System, a thrombectomy device. However, it does not include detailed acceptance criteria or a study designed to explicitly prove the device meets these criteria in a quantitative, statistical manner as would be expected for a typical AI/software device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparative performance testing.

Therefore, many of the requested fields cannot be directly populated from the input provided. I will fill in what can be inferred or directly stated and note when information is unavailable.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance Study for X-SIZER® Catheter System

The provided documentation details the X-SIZER® Catheter System's premarket notification (510(k)) for substantial equivalence to legally marketed predicate devices. The performance data presented focuses on demonstrating that the X-SIZER® Catheter System is as safe and effective as these predicate devices, rather than meeting pre-defined quantitative acceptance criteria with specific threshold values for performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria with numerical thresholds are not provided, the table below reflects the comparative performance assessment described in the document.

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

• Sample Size (Test Set): Not explicitly stated in terms of number of samples/cases. The document refers to "a bench model simulating synthetic hemodialysis grafts" and "an in vivo animal model utilizing thrombosed hemodialysis grafts" for comparative testing. Specific numbers of grafts or experimental runs are not provided.
• Data Provenance: The studies were in vitro (bench model) and in vivo (animal model). The country of origin is not specified but is presumably overseen by the US regulatory system given the FDA submission. These appear to be prospective studies conducted specifically for this 510(k) submission.

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 this device's performance is established through direct physical measurements and observations in in vitro and in vivo models, not through expert review of data/images. The assessment of "equivalence" would involve technical experts (engineers, scientists, veterinarians) conducting and analyzing the tests. Their number or specific qualifications beyond general expertise in medical device testing are not detailed.

4. Adjudication method for the test set

Not applicable. As the performance assessment is based on physical and physiological measurements/observations in bench and animal models rather than expert interpretation of data, there is no expert adjudication method like 2+1 or 3+1.

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 mechanical thrombectomy catheter, not an AI or imaging device that involves human readers or AI assistance.

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

Not applicable. This device is a mechanical thrombectomy catheter, not an algorithm.

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

The ground truth or reference standard for this device's performance is based on:

• In vitro measurements: Direct quantitative measurements from bench tests (e.g., flow rate, output, tensile strength, battery life, corrosion resistance, clot extraction efficiency).
• In vivo observations/measurements: Direct observations and possibly post-procedure analysis (e.g., histology for vessel trauma, assessment of distal embolization, overall efficacy in thrombus removal) in the animal model.

8. The sample size for the training set

Not applicable. This device is a mechanical thrombectomy catheter, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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The 0.035'' and 0.025'' Guidewire is indicated for use in the peripheral vasculature. The 0.014'', 0.016'', and 0.018'' guidewires are indicated for use in the peripheral and coronary vasculature.

The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.

Here's an analysis of the provided text regarding the EV3 Nitrex™ Nitinol Guidewire.

Important Note: The provided document is a 510(k) summary for a medical device (guidewire). For this type of device, the "acceptance criteria" and "device performance" usually refer to engineering specifications and physical testing, not clinical performance metrics like sensitivity, specificity, or accuracy which are common for AI/diagnostic devices. Similarly, concepts like "ground truth," "experts," "adjudication," and "MRMC studies" are typically not applicable to guidewires.

The document describes a submission for substantial equivalence based on physical and dimensional testing, comparing it to predicate devices. It does not contain information about studies involving AI, human readers, or clinical outcomes that would typically have the metrics and study design elements requested in the prompt.

Given this context, I will extract the information that is present and indicate where the requested information is not applicable to this type of device submission.

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

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

• Sample Size: Not specified for dimensional or verification/validation testing.
• Data Provenance: Not specified, but likely internal testing by EV3 in the USA, as per their address. This is not a clinical study involving patient data.

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

• Not Applicable. This is a physical device, and "ground truth" in the diagnostic sense is not relevant. The "ground truth" for manufacturing would be adherence to engineering specifications and successful functional testing, typically performed by engineers/technicians.

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

• Not Applicable. Adjudication is not relevant for dimensional and functional testing of a guidewire.

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

• No. This is not an AI or diagnostic device.

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

• No. This is not an AI or algorithm-based device.

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

• Not Applicable. The "ground truth" for this device relates to its physical properties meeting design specifications and its functional performance during testing (e.g., ability to advance smoothly, tip flexibility, etc.) compared to predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI or learning-based system.

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

• Not Applicable. This is not an AI or learning-based system.

Summary of Device and Study (Based on 510(k) Summary):

The EV3 Nitrex™ Nitinol Guidewire is a Class II medical device used in peripheral and coronary vasculature. The submission (K031864) is for substantial equivalence to existing predicate guidewires. The "study" mentioned is internal "dimensional inspection" and "verification/validation testing" performed by the manufacturer, EV3. The stated outcome is that "All testing of the product yielded acceptable results" and modifications did not affect original results, leading to the FDA's finding of substantial equivalence based on intended use, materials, labeling, and principles of operation being similar to predicate devices. No clinical trial, AI component, or human reader study is described in this document.

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The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.

The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.

This document is a 510(k) summary for the Nitrex™ Nitinol Guidewire, submitted to the FDA in 2003. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for new device performance metrics in the way a modern AI/ML device submission would.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "All testing of the product yielded acceptable results." However, it does not explicitly list quantitative acceptance criteria for each specific test (e.g., "tensile strength > X N," "coating adhesion > Y score"). The acceptance criteria are implied to be adherence to internal specifications and relevant standards. This is common for predicate-based medical device submissions that focus on substantial equivalence.

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

The document does not specify sample sizes for any of the performance tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to be conducted in a laboratory setting (in-vitro and simulated conditions).

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

This information is not applicable and not provided in this type of submission. This document describes the testing of a physical medical device (guidewire), not an AI/ML algorithm that requires expert-established ground truth from a dataset.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, this is for a physical device, not an AI/ML algorithm requiring expert adjudication of data.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists, pathologists). The Nitrex™ Nitinol Guidewire is a physical interventional device, not an AI diagnostic or assistance tool.

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

There was no standalone (algorithm only) performance study done. This is not an AI/ML device. The "standalone performance" here refers to the guidewire's physical characteristics and functionality.

7. The Type of Ground Truth Used

The "ground truth" for this device's testing would be defined by engineering specifications, material science standards, and established in-vitro performance test methods. For example, the "ground truth" for tensile strength would be the measured force at which the guidewire breaks, compared against a pre-defined acceptable range. For biocompatibility, the ground truth is adherence to ISO 10993-1 guidelines and testing results.

8. The Sample Size for the Training Set

There is no training set for this device. This is a physical medical device, not an AI/ML algorithm that undergoes training.

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

This question is not applicable as there is no training set mentioned for this physical medical device.

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