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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 Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent is placed using fluoroscopic and percutaneous techniques.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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The Cook Zilver® 518 TM Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Zilver® 518™ Biliary Stent with a diameter of 10 mm is a self-expanding, nitinol stent designed for superior 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® 518" Billary Stent, along with radiopaque markers on the delivery system, allow precise positioning of the stent's interconnected Zshaped seqments also keep foreshortening to a minimum.

The Zilver® 518" Biliary Stent comes preloaded in a 5 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is currently available in unrestrained outer diameters of 4, 5, 6, 7, 8, and 9mm and in lengths of 20, 30, 40, 50 and 60 mm. The 10 mm diameter stent is an addition to this product line.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zilver® 518™ Biliary Stent.

It's important to note that this document is a 510(k) summary for a medical device (stent), not a diagnostic AI/ML device. Therefore, the concepts of "experts establishing ground truth," "adjudication methods," "MRMC studies," "standalone algorithms," "training sets," and "data provenance" (in the context of clinical images/data for AI) are not directly applicable to this type of device submission. Instead, the "acceptance criteria" here refer to engineering and performance specifications, and the "study" is a series of mechanical and physical tests demonstrating these specifications are met.

Device: Zilver® 518™ Biliary Stent

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list numerical acceptance criteria with corresponding numerical performance results in a table format. However, it indicates the types of tests performed to assure reliable design and performance. The "performance" is implicitly stated as having "conformance to the requirements for its use as a biliary stent."

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

• Sample Size: The document does not specify the exact number of stents or test iterations used for each test. It refers to "the Zilver® 518™ Biliary Stent was subjected to the following tests."
• Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory/bench tests.

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 this device is established by engineering specifications, physical measurements, and possibly simulated use, not by clinical expert consensus on interpreting images or patient conditions.

4. Adjudication method for the test set

Not applicable. This concept applies to expert review of clinical cases, not mechanical 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

Not applicable. This is a medical device (stent), not an AI-assisted diagnostic tool.

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 AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and physical-mechanical measurements. For example, the "ground truth" for radial force would be a specific predefined value or range that the stent must demonstrate in a laboratory setting. Similarly, for deployment accuracy, the "ground truth" would be the measured deviation from the intended deployment location.

8. The sample size for the training set

Not applicable. This concept applies to AI/ML models. For medical devices, there isn't a "training set" in the computational sense, but rather a design and development process that involves iterative testing and refinement.

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

Not applicable. See point 8.

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The Zilver® 518™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

The Zilver® 518 " Biliary Stent is a self-expanding, nitinol stent designed for superior 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® 518 " Biliary Stent, along with radiopague markers on the delivery system, allow precise positioninq of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum. The Zilver® 518 " Biliary Stent comes preloaded in a 5 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, and 9 mm and in lengths of 20, 30, 40, 50 and 60 mm.

Here's an analysis of the provided text regarding the Zilver® 518™ Biliary Stent, focusing on acceptance criteria and study details.

Based solely on the provided text, the document primarily describes the device, its intended use, and substantial equivalence to predicate devices, along with the types of tests performed. It does not provide specific acceptance criteria values or detailed performance results in the format typically requested for AI/device performance studies. The document is a 510(k) summary for a medical device approval, which focuses on demonstrating substantial equivalence, and not on detailed performance metrics as would be found in a clinical trial report.

Therefore, many of the requested fields cannot be filled with specific data from this document. I will extract what is present and explicitly state when information is not available.

Description of Acceptance Criteria and Study:

The Zilver® 518™ Biliary Stent was subjected to a series of tests to assure reliable design and performance. These tests were comprised of:

1. Deployment:
   • Profile
   • Deployment Accuracy
   • Stent length and Change due to Deployment
   • Stent Diameter
   • Uniformity of expansion
   • Stent Integrity
   • Ease of Deployment
2. Radial Force
3. Finite Element Analysis
4. Biocompatibility - ISO 10993-1

The document states that "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." However, the specific quantitative acceptance criteria (e.g., "Deployment Accuracy must be within X mm") and the reported device performance metrics (e.g., "Deployment Accuracy was Y mm") are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the document. The tests listed are primarily bench/engineering tests, and the "sample size" would refer to the number of stents or components tested under each condition. This information is not provided.
• Data Provenance: Not specified. As these are bench tests for a medical device manufacturer (Cook Incorporated, Bloomington, Indiana, USA), it can be inferred the tests were likely conducted internally or by contracted labs, presumably within the US or a region adhering to similar standards. The data is likely prospective for these specific tests as they were performed to support the 510(k) submission.

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 more applicable to clinical studies or studies involving human interpretation (e.g., imaging devices). The listed tests are primarily physical and chemical performance tests of the device itself. Therefore, "ground truth" would be established by validated test methodologies and instrument calibration, not by human expert consensus in the typical sense.
• The "experts" would be the engineers, scientists, and technicians performing and validating the tests, but no specific number or qualifications are provided here.

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

• Not applicable to the types of engineering and laboratory tests described. Adjudication methods are typically used in clinical studies or human-reader performance evaluations to resolve discrepancies in diagnoses or assessments.

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. An MRMC comparative effectiveness study was not done. This document describes the approval of a physical medical device (a stent), not an AI algorithm or an imaging diagnostic tool that would involve human readers or AI assistance.

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

• No. This is not an algorithm, but a physical medical device. Therefore, a standalone algorithm performance study is not applicable.

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

• For the physical and chemical tests listed, the "ground truth" is based on objective measurements obtained from validated testing equipment and adherence to relevant industry standards (e.g., ISO 10993-1 for biocompatibility). It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense. For example, stent length change would be measured directly, and the true value is the measured value from the test instrument.

8. The sample size for the training set

• Not applicable. This document describes the approval of a physical medical device, not an algorithm that requires a training set. The device design and presumably iterative testing inform product development, but this is not analogous to an algorithm's training set.

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

• Not applicable. As a training set is not relevant to this type of device approval, the establishment of its ground truth is also not applicable.

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