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The Captus Vascular Retrieval System is intended for use in the cardiovascular system to retrieve foreign objects, including, but not limited to guide wires, coils, balloons, catheters, and filters.

The Captus Vascular Retrieval System consists of a flexible polyetheretherketone (PEEK) and Pebax shaft with a nitinol Braided Loop Snare (BLS) on the distal end. The device is designed to capture and retrieve foreign objects from the cardiovascular system. The lumen of the 120 cm long flexible snare shaft contains an inner rod that is secured to the BLS using an ultra-high molecular weight polyethylene (UHMWPE) braided suture. The external torquer is attached to the proximal end of the shaft and supports BLS manipulation. During the procedure, once the distal end has been positioned near the foreign object, the torquer can be turned clockwise (in relation to the shaft) in order to cinch the BLS. This feature allows the foreign object to be more firmly secured before its retrieval.

The provided text describes the 510(k) premarket notification for the Captus Vascular Retrieval System. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human-in-the-loop studies, multi-reader multi-case (MRMC) studies, or detailed ground truth establishment as would be expected for an AI/ML medical device.

The document primarily focuses on demonstrating the substantial equivalence of the Captus Vascular Retrieval System to predicate devices according to FDA's 510(k) process. This involves non-clinical testing to demonstrate safety and performance based on industry standards for medical devices, rather than an AI/ML algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with respect to AI/ML performance, as this information is not present in the provided text.

Specifically, the document states:

• "No FDA performance standards have been established for the Captus System." This indicates that the type of quantitative performance metrics (like sensitivity, specificity, or AUC) typically seen with AI/ML devices and their associated acceptance criteria are not relevant to this submission.
• The tests performed are biocompatibility, design verification and performance tests (e.g., total length, tensile strength, leak), corrosion resistance, and simulated use testing. These are traditional engineering and material science tests for a physical medical device.
• "A feasibility study documenting the retrieval of various foreign bodies from the vascular system was performed to demonstrate that the device is appropriate with the stated indications." This is a functional test, likely in a lab or animal model, not an AI/ML performance study.

In summary, the provided text does not contain the information required to answer your prompt because the Captus Vascular Retrieval System is a physical medical device, not an AI/ML algorithm, and its approval process does not involve the types of studies you've outlined for AI/ML performance claims.

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The DuraMax™.018 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree

The DuraMax™.018 Biliary Stent Delivery System is a balloon- expandable 316L stainless steel stent pre-mounted on a delivery catheter. The delivery catheter is an Over-the-Wire (OTW) design with a distal balloon and two radiopaque markers to aid in the placement of the stent. The proximal end of the catheter has a Y-connector that allows for the use of a guidewire ≤0.018" and the attachment of a balloon inflation device via a standard luer connector. Stents sizes include diameters of 5, 6 & 7 mm in lengths of 13, and 18 mm. The catheter is available in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103 cm are provided on the 135 cm catheter. The catheter system is provided sterile and is intended for one use only.

The DuraMax™ .018 Biliary Stent System has achieved substantial equivalence based on a comparison to a predicate device and extensive non-clinical testing. Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not mention any human clinical study or "test set" in the context of a comparative effectiveness study with human subjects. The safety and effectiveness were demonstrated using "non-clinical design verification tests and analyses" and "bench and Biocompatibility testing." Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this case.

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

This information is not applicable as the document does not describe a study involving human experts establishing ground truth for a test set. The evaluation was based on non-clinical testing and comparison to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a study involving human experts and adjudication for a test set.

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 is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers improving with AI in the provided documents. The DuraMax™ .018 Biliary Stent System appears to be a medical device (stent and delivery system), not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the DuraMax™ .018 Biliary Stent System is a physical medical device, not an algorithm, and its performance would not be evaluated in a "standalone" algorithmic context.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established through:

• Non-clinical design verification tests and analyses (Bench testing): This refers to laboratory testing to evaluate the device's physical properties, mechanical performance, and functional characteristics against predetermined specifications.
• Biocompatibility testing: This confirms that the materials used in the device are safe for contact with the human body and do not elicit adverse biological responses.
• Comparison to a predicate device: The device's characteristics and intended use were deemed "substantially equivalent" to the Cordis® PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM .018" Delivery System, implying that the predicate's established safe and effective performance serves as a benchmark for the DuraMax system.

8. The Sample Size for the Training Set

This information is not applicable. The DuraMax™ .018 Biliary Stent System is a physical medical device, not a machine learning model, and therefore did not undergo "training" with a dataset in that sense. The "training" in this context would likely refer to the design, engineering, and manufacturing processes that led to the device's creation.

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

This information is not applicable for the same reasons as #8. The "ground truth" for the device's design and manufacturing would be established through engineering principles, material science, and quality control processes to ensure it meets its specifications.

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The DuraMax™ .035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

The DuraMax™ .035 Biliary Stent Delivery System is a balloon- expandable 316L stainless steel stent pre-mounted on a delivery catheter. The delivery catheter is an Over-the-Wire (OTW) design with a distal balloon and two radiopaque markers to aid in the placement of the stent. The proximal end of the catheter has a Y-connector that allows for the use of a guidewire ≤ 0.035" and the attachment of a balloon inflation device via a standard luer connector. Stents sizes include diameters of 7, 8, 9 & 10 mm in lengths of 18, 28 and 28 mm. The catheter is available in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103 cm are provided on the 135 cm catheter. The catheter system is provided sterile and is intended for one use only.

The provided text describes the 510(k) premarket notification for the DuraMax™ .035 Biliary Stent System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove predetermined acceptance criteria through specific performance metrics.

Therefore, many of the requested sections about explicit acceptance criteria and a detailed study proving performance against them cannot be extracted directly from this document. The submission is based on comparison and non-clinical testing.

Here's an analysis of the provided text in relation to your request:

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

This information is not explicitly stated in the provided document in the form of a table with specific performance metrics and acceptance criteria. The document states:

• "Performance Standards Have not been established for this device."
• "The safety and effectiveness of the DuraMax™ .035 Biliary Stent Delivery System have been demonstrated with data collected form non-clinical design verification tests and analyses."

The conclusion of the safety and effectiveness is presented as:

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

This information is not provided in the document. The document mentions "non-clinical design verification tests and analyses," which typically refer to bench testing, not clinical studies with human subjects or a defined test set of patients/data. Therefore, there's no "sample size" in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/not provided. The document describes non-clinical testing for design verification and analyses, not a clinical study requiring expert ground truth establishment for a test set of cases.

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

This information is not applicable/not provided. There is no mention of a test set with adjudicated ground truth, as the study was non-clinical.

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

This information is not applicable/not provided. The device is a physical medical device (a stent system), not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided. The device is a physical medical device, not an algorithm.

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

This information is not applicable/not provided. Ground truth in the clinical sense is not relevant for the described non-clinical design verification tests. These tests would typically compare device performance against engineering specifications or established standards for components.

8. The sample size for the training set

This information is not applicable/not provided. The document describes a traditional medical device, not a machine learning model that requires a "training set."

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

This information is not applicable/not provided, as there is no training set mentioned in the context of this device's evaluation.

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The Admiral™ .035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.

The Admiral™ .035 Dilatation Catheter is an Over-the-Wire, Coaxial, dual lumen design with a inflatable balloon on the distal end and compatible with 0.035" guidewires. Two radiopaque markers indicate the dilating portion of the balloon and aid in balloon placement. The device is available with balloon diameters of 7.0 - 10.0 mm, balloon lengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm.

The provided text describes the 510(k) summary for the Admiral™.035 Dilatation Catheter, a Peripheral Transluminal Angioplasty (PTA) Catheter. The document outlines performance testing conducted to demonstrate its safety and effectiveness, and for comparison to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for specific performance tests (e.g., how many catheters were tested for burst strength, fatigue, etc.). It only states that "Performance testing was conducted." The data provenance is also not detailed regarding geographical origin or whether the tests were retrospective or prospective, though bench testing implies a controlled, prospective lab environment. However, the study is a bench study, meaning it was conducted in a laboratory setting using physical specimens of the device, not on human or animal subjects.

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

This information is not applicable to this type of device submission. This is a medical device, and the evaluation is based on engineering and materials performance, not on interpretation of medical images or patient data by human experts for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as there are no human interpretations or judgments to adjudicate in the described bench testing.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a physical medical device (catheter), not an AI diagnostic or assistive technology for human readers.

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

No, this is not an algorithm or AI technology. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Engineering specifications and standards: The device's physical properties are measured against established engineering requirements and industry norms for catheters.
• Predicate device characteristics: The predicate device serves as a benchmark for comparison in terms of materials, design, dimensions, and intended use.
• Biocompatibility standards: International and national standards for biological safety of medical devices are used as the ground truth for biocompatibility testing.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI or machine learning device requiring a training set.

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

This information is not applicable as this is not an AI or machine learning device requiring a training set.

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