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The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

The Zilver® 518 and 635TM Biliary Stent is a self-expandable stent made of nitinol. The special laser-cut pattern of the nitinol tube provides a construction with strong radial force and high flexibility. It is a slotted tube that is designed to provide support while maintaining flexibility in the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining constant flow in the duct. The stent has radiopaque markers (gold rivets) at both ends to assist in fluoroscopic visualization of the stent position. The delivery system for both ZIB5 and ZIB6 devices includes a handle assembly and an introducer catheter assembly. The Zilver® 518 and 635™ Biliary Stent is mounted on the inner catheter of the delivery system and is restrained by an outer sheath. The delivery system is used to deliver the stent to the appropriate location. The stent is deployed by retracting the outer sheath while holding the central metal cannula stationary. Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent is placed using fluoroscopic and percutaneous techniques.

This is a 510(k) premarket notification for a medical device, not an AI/ML-powered device. Therefore, the common acceptance criteria and study information typically associated with AI models (such as AUC, sensitivity, specificity, MRMC studies, training/test set details, and ground truth establishment) are not applicable.

The document describes the Zilver® 518™ Biliary Stent and Zilver® 635™ Biliary Stent, which are physical medical devices (self-expandable stents). The submission, K182980, is for a modification to the instructions for use of an already cleared device (K163169).

Here's a breakdown of the relevant information provided in the context of the device:

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

Since this is a submission for a modification to "Instructions for Use" and not a new device or a device with new functionality requiring performance metrics, there are no specific performance acceptance criteria or reported device performance metrics in the typical sense (e.g., accuracy, sensitivity). The "acceptance criteria" here relate to demonstrating substantial equivalence for the modified labeling.

The key "acceptance criteria" for this 510(k) appears to be:

• Substantial Equivalence: The modified device (with updated IFU) must be substantially equivalent to the predicate device (Zilver® 518™ and 635™ Biliary Stent, K163169).

Reported Device Performance:
The document explicitly states: "There were no device changes, therefore no additional testing was required to support the determination of substantial equivalence to the predicate devices." This implies that the performance of the device itself (mechanical, biological, etc.) was already established with the predicate device submission (K163169) and is implicitly considered to meet all relevant performance standards. The current submission does not present new performance data.

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of evaluating an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI model requiring "ground truth" establishment by experts.

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 not an AI-assisted device.

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.

8. The sample size for the training set: Not applicable.

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

In summary: This document is related to a Class II medical device (biliary stent), and the 510(k) submission is specifically for changes to the Instructions for Use (IFU). It asserts substantial equivalence to a previously cleared predicate device (K163169) and states that no additional testing was required because there were no changes to the device's design or materials, only to the labeling. Therefore, the questions related to AI/ML model performance evaluation do not apply to this submission.

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This device is used in palliation of malignant neoplasms in the biliary tree

The Zilver 635® Biliary Stent (ZILBS-635) consists of the following two components: a selfexpanding metal stent and stent delivery system. The stent is a laser cut self-expanding openended cylinder of nitinol. It is a slotted tube that is designed to provide support while allowing conformance to the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining flow in the duct. The ZILBS-635 has radiopaque markers at both ends to assist in fluoroscopic visualization of the stent position. This stent delivery system like the predicate devices allows for co-axial deployment of the stent delivery system accepts a 0.035 inch wire guide. The stent delivery system includes a handle assembly and an introducer assembly. The handle assembly consists of a handle, a wire guide FLLA, holding bushing, a cannula, a check flo hub FLLA/cap and a safety tab. The introducer assembly consists of an outer sheath, an inner carrier and tip. The stent delivery system has an endoscopic pusher ring located on the inner carrier near the proximal end of the loaded stent. The outer sheath has a radiopaque maker band located within the wall of the outer sheath at the distal end. The stent delivery system is supplied with a syringe for flushing through the wire guide FLLA and the check flo hub FLLA.

This document is a 510(k) premarket notification for the Zilver 635® Biliary Stent, seeking substantial equivalence to previously cleared predicate devices. Since this is a submission for a medical device and not an AI/ML product, the information you've requested (acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, etc.) is not applicable or present in the provided text.

The document focuses on demonstrating that the Zilver 635® Biliary Stent (ZILBS-635) is substantially equivalent to existing predicate devices (Zilver® 635™ Biliary Stent and Zilver® Biliary Stent) for the palliation of malignant neoplasms in the biliary tree.

Here's an overview of the information that is available in the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of AI/ML or a clinical study evaluating effectiveness against specific performance metrics for the device in vivo. Instead, it refers to "Performance Data" which includes:

• Biocompatibility evaluation: Conducted in accordance with FDA's Use of International Standard ISO 10993-1.
• Performance testing: "simulated use, deployment testing, dimensional testing, joint strength testing, MRI and shelf life testing were performed as per Cook's design control system."

The specific quantitative results or acceptance criteria for these tests are not provided in this summary. The general conclusion is that "The non-clinical data supports the safety of the subject device and demonstrates that the Zilver 635® Biliary Stent (ZILBS-635) is safe and effective and should perform as intended in the specified use conditions."

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

This information is not applicable and is not present in the document. The document describes non-clinical performance testing (e.g., biocompatibility, simulated use, mechanical testing) rather than a clinical study with a test set of patient 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 and is not present in the document, as it pertains to medical devices and not an AI/ML diagnostic or prognostic tool.

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

This information is not applicable and is not present in the document.

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 and is not present in the document, as it pertains to medical devices and not an AI/ML diagnostic or prognostic tool.

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

This information is not applicable and is not present in the document.

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

This information is not applicable and is not present in the document. For a medical device like a stent, "ground truth" would typically refer to the physical and mechanical properties meeting engineering specifications, and evidence of safety and performance in simulated and potentially clinical environments. The document refers to "biocompatibility evaluation," "simulated use, deployment testing, dimensional testing, joint strength testing, MRI and shelf life testing" as the basis for demonstrating safety and effectiveness.

8. The sample size for the training set

This information is not applicable and is not present in the document.

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

This information is not applicable and is not present in the document.

In summary, the provided text is a regulatory submission for a medical stent, focusing on demonstrating substantial equivalence to predicate devices through engineering and non-clinical performance testing. It does not contain any information related to AI/ML device performance or the specific criteria and studies you've asked about in that context.

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The Cook Zilver® 635" Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 635" Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The Zilver® 635" Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent's interconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 and 80 mm. The 100, 120, and 140 mm length stents are an addition to this product line.

The provided text is a 510(k) summary for a medical device (Zilver® 635™ Biliary Stent System), not an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to an AI/ML study.

The document discusses the substantial equivalence of the Zilver® 635™ Biliary Stent to predicate devices based on intended use, materials, and technological characteristics. It also details physical tests performed on the device to ensure reliable design and performance.

Here's an attempt to answer the questions based on the physical device testing mentioned, acknowledging that it's not an AI/ML study:

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

The document does not explicitly list quantitative acceptance criteria in a table format. It states that the device was subjected to tests "to assure reliable design and performance under the specified testing parameters." The "results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." This implies that the device met the unstated acceptance criteria for each test.

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

The document does not specify the sample sizes (number of stents) used for each physical test. It only mentions "The Zilver® 635" Biliary Stent was subjected to the following tests..." This is typical for physical device testing where a sufficient number of units are tested to demonstrate consistency and compliance.

The data provenance is internal to Cook Incorporated, likely conducted in their facilities in the USA. These would be prospective physical tests, not data from patients.

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 question is not applicable to the provided document. Ground truth, in the context of AI/ML, refers to labels derived from expert review of patient data. Here, the "ground truth" would be the engineering specifications and performance requirements for the physical stent, established by Cook's engineering and quality teams, not by medical experts reviewing patient data.

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

Not applicable. Adjudication methods are used in clinical studies or expert review of data. These were physical engineering tests, where results are measured against predefined specifications, not adjudicated by a panel.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for these physical tests would be the engineering specifications and performance requirements set for the device. For example, a stent must deploy within a certain profile, have a specific radial force, and maintain integrity. These are not derived from expert consensus on medical images, pathology, or patient outcomes, but from design documents and industry standards for medical devices.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and thus no training set.

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

Not applicable. There is no AI/ML model, and thus no ground truth for a training set.

In summary: The provided 510(k) summary is for a physical medical device (a stent) and details physical performance tests against design specifications, not an AI/ML system's diagnostic or predictive performance. Therefore, most of the requested information regarding AI/ML study design and metrics is not present in the document.

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The Cook® Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Zilver® 635 " Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 and 80 mm. The 9, 10, 12, and 14 mm diameter stent with a cannula outside diameter of 1.6 mm is an addition to this product line.

The Cook Zilver® 635™ Biliary Stent is a medical device and thus does not involve AI/ML. Much of the requested information (e.g., sample size for training set, number of experts, adjudication method) is not applicable to this type of medical device as it is not an AI/ML device.

Here's a breakdown of the acceptance criteria and study information provided for the Cook Zilver® 635™ Biliary Stent, based on the provided text:

1. Table of acceptance criteria and reported device performance:

The provided text generally describes the types of tests performed rather than specific numerical acceptance criteria or detailed results for each test. The summary states that the results "provide reasonable assurance that the device has requirements for its use as a biliary stent," indicating that acceptance criteria were met.

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

• Sample Size: Not explicitly stated for each test. The document mentions "tests" in plural, implying multiple units were tested, but no specific count is given.
• Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer (Cook Incorporated) as part of their design verification and validation process in a controlled lab setting. It is not patient data.

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

• Not Applicable. This is a hardware medical device (stent). The "ground truth" for its performance is established through physical and mechanical testing against engineering specifications, not expert consensus on diagnostic images or clinical outcomes in the same way an AI/ML algorithm's ground truth would be established.

4. Adjudication method for the test set:

• Not Applicable. As this is a mechanical device, there is no expert adjudication of results in the context of diagnostic interpretation. Results are typically based on objective measurements and established engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Not Applicable. This is a physical medical device. The concept of an "algorithm-only" performance does not apply.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on engineering specifications and performance metrics defined by the manufacturer and relevant industry standards for biliary stents (e.g., measurements of deployment accuracy, radial force, crimped profile).

8. The sample size for the training set:

• Not Applicable. This is a hardware medical device. There is no "training set" in the context of machine learning. The device design is based on engineering principles and materials science, not data-driven training.

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

• Not Applicable. As there is no training set for a machine learning model, this question does not apply. The design of the stent (e.g., Z-shaped segments, nitinol material) is based on established engineering and biomedical knowledge to achieve desired mechanical properties.

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The Cook Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Zilver® 635™ Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum. The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 mm. The 80 mm length stent is an addition to this product line.

This is a
510(k) premarket notification for a medical device, not an AI/ML device. The provided text is a summary of the device, its predicate devices, and the tests performed to assure its design and performance. There is no mention of acceptance criteria related to AI/ML performance metrics, studies involving human readers, or ground truth establishment for AI model training. Therefore, I cannot generate the requested information about acceptance criteria and study details for an AI/ML device.

The document discusses "Test Data" for the Zilver® 635™ Biliary Stent, which includes:

• Deployment
  • Profile
  • Deployment Accuracy
  • Stent length and Change due to Deployment
  • Stent Diameter
  • Uniformity of Expansion
  • Stent Integrity

However, these are performance tests for a physical medical device (a biliary stent), not a study assessing the performance of an AI/ML algorithm.

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The Cook Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Zilver® 635" Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped seqments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver" 635 " Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum. The Zilver® 635" Biljary Stent comes prefoaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9,and 10 mm and in lengths of 20, 30, 40, 50 and 60 mm.

This device is a medical implant, and the provided text describes its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a study against a pre-defined acceptance criteria for diagnostic/AI performance. The information you requested, particularly regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies, is not typically part of a 510(k) submission for this type of device (a biliary stent).

However, I can extract the relevant information pertaining to the device's functional performance testing as described in the submission.

Here is the information based on the provided text, heavily inferring where direct answers to your questions are not present due to the nature of the submission (device not AI/diagnostic):

1. Table of Acceptance Criteria (Inferred Functional Performance) and Reported Device Performance

Note: The submission states "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." This implies that the device met the pre-defined acceptance criteria for each of these functional tests, without detailing the specific numerical thresholds for those criteria in this summary.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not applicable in the context of device functional testing described. These are laboratory/bench tests, not clinical 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, in the diagnostic sense, is not established for these functional device performance tests. These tests are based on engineering specifications and measurements.

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

• Not applicable. This concept pertains to expert review in diagnostic studies, not functional device 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. This is a medical device (stent), not an AI/diagnostic software.

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

• No. This is a medical device (stent), not an AI/diagnostic software.

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

• For the functional tests described, the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring stent diameter, deployment accuracy against a defined target, tensile strength against a known material property standard). It's based on physical measurements and material science, not clinical ground truth.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device. The design and manufacturing processes are likely informed by engineering principles and previous device designs, but there isn't a "training set" in the AI sense.

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

• Not applicable. See point 8.

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