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The DYNALINK™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

The 12 mm and 14 mm DYNALINKING Stent Systems are catherers designed to deploy a selfexpanding nickel titanium (Nitinol) stent into the biliary tree. The catherer body is constructed from two coaxial members. The inner member (IM) is comparible with a 0.035" guide wire in an over the wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly. The distal end of the delivery system includes either the 12 mm or the 14 mm DYNALINK™ Stent held in its constrained state by the stem-restraining sheath, a soft, low profile tip, and two radio-opaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system. the user interface is composed of a pull-back handle attached to the OM, a shaped housing that allows the handle to slide axially, and a luer firting that is rigidly fixed to the shaped housing. The 12 mm and 14 mm DYNALINK™ Stents are fabricated from superclastic nickel-titanium (niunol) in a series of serpentine rings that are aligned along a common longitudinal axis. The stent is laser cut from a tube of superelastic minnol. All of the stent diameters are cut with similar stent patterns, and the stent is expanded and heat-treated to be stable at the desired final diamerer. The stens are electropolished to obtain a smooth finish with a thin layer of itanium oxide on the surface.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the DYNALINK™ .035 Biliary Self-Expanding Stent System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided M8 data, the device is a medical stent, and the performance evaluated is for its safety and effectiveness, primarily through in vitro bench tests and analyses. This type of device's "performance" isn't typically measured by diagnostic metrics like sensitivity or specificity. Instead, it would focus on physical and mechanical properties relevant to its function and biocompatibility.

Since the document does not explicitly state numerical "acceptance criteria" or specific "reported device performance" values in a table format for each criterion, I will infer the categories of assessment based on the text. The document primarily focuses on establishing substantial equivalence to a predicate device.

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

• Sample Size: Not explicitly stated as a number of devices or iterations. The study was conducted through "in vitro bench tests and analyses." For bench tests, "sample size" typically refers to the number of units tested to ensure statistical confidence in the results, but this detail is not provided in the summary.
• Data Provenance: The study was conducted using in vitro bench tests and analyses, meaning it was not performed on human subjects or animals. The location or country of origin for these bench tests is not specified, but given the submitter's address (Santa Clara, CA), it's highly probable they were conducted in the USA. The data is not prospective or retrospective in the clinical sense, as it refers to laboratory testing, not patient data.

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 therefore not provided in the document. For a medical device like a stent undergoing in vitro bench testing for substantial equivalence, "ground truth" established by human experts (like radiologists) for a "test set" (like medical images) is not relevant. The "ground truth" for bench tests would be defined by engineering specifications, material properties' standards, and validated testing methodologies.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert review of cases to resolve discrepancies in diagnoses or assessments. For engineering bench testing, the "adjudication" of results would follow standard engineering and quality control protocols to ensure test validity and accurate data collection.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a stent that is a physical implant, not an AI diagnostic tool.

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

No, a standalone study as described (algorithm only without human-in-the-loop performance) was not done. This type of study is for AI algorithms. The device in question is a physical stent, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is based on engineering specifications, material science standards, and established in vitro testing methodologies. For example:

• Mechanical properties: Measured values (e.g., radial force, fatigue life, deployment force) are compared against established acceptance limits or performance of the predicate device.
• Material composition: Confirmed against material specifications (Nitinol, specific surface treatments).
• Dimensional accuracy: Measured against design specifications.
• Biocompatibility: Demonstrated through validated tests or material equivalency to a predicate.

The ultimate "ground truth" for substantial equivalence is demonstrating that the new device performs at least as safely and effectively as the legally marketed predicate device under these technical and performance parameters.

8. The Sample Size for the Training Set

This information is not applicable for this device. A "training set" refers to data used to train machine learning models. This device is a physical medical implant, not an AI algorithm.

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

This information is not applicable for this device, as there is no "training set."

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The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.

The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree.

The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a .035" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly.

The acceptance criteria and the study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not detail specific sample sizes for a "test set" in the context of clinical or human data. The performance data primarily relies on "in vitro bench tests and analyses." Therefore, information on data provenance (e.g., country of origin, retrospective/prospective) for a test set of human data is not applicable here.

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

This information is not provided. Since the performance data is based on in vitro bench tests, the concept of establishing ground truth by medical experts in the way it applies to clinical studies is not relevant.

4. Adjudication Method for the Test Set:

This information is not provided. As the performance data is from in vitro bench tests, adjudication methods typically used for interpreting human data are not applicable.

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

No MRMC comparative effectiveness study was mentioned. The device is a physical medical device (a biliary stent system), not an AI-assisted diagnostic or interpretative tool. Therefore, this type of study is not relevant to this submission.

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

This is not applicable as the device is a physical stent system.

7. The Type of Ground Truth Used:

The ground truth for demonstrating safety and effectiveness was based on the results of in vitro bench tests and analyses. This would involve engineering specifications, material properties, mechanical testing results, and other laboratory-based evaluations.

8. The Sample Size for the Training Set:

This information is not provided. The concept of a "training set" in the context of developing an algorithm or AI model for diagnostic or predictive purposes is not applicable to this physical medical device. The "training" for such a device would typically involve engineering design, prototyping, and iterative bench testing.

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

This information is not explicitly detailed. For a physical device like a stent, "ground truth" during development (analogous to a training set for algorithms) would be established through engineering design specifications, materials science principles, and iterative bench testing to ensure the device met predetermined performance criteria (e.g., expansion force, radial strength, fatigue resistance, biocompatibility). These criteria would be based on established industry standards and clinical needs for biliary stent functionality.

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The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.

The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree. The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a 0.035" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly. The distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding Stent in its constrained state within the restraining sheath, a soft, low profile tip, and two radi-opaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system is a pull-back handle that is free to slide axially, and a luer fitting that is rigidly fixed to the shaped housing. The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickel titanium (Nitinol). The stent is comprised of a series of rings that are aligned along a common longitudinal axis. The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut with a similar stent pattern. The stent is expanded and heat-treated to be stable at the body temperature. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface. The DYNALINK™ Biliary Self-Expanding Stent is available in diameters of 5-10 mm and in lengths of 28, 38, and 56 mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DYNALINK™ .035 Biliary Self-Expanding Stent System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and corresponding performance metrics from a study are not explicitly stated. The document primarily focuses on establishing substantial equivalence to a predicate device and broadly mentions performance data without quantitative details.

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

• Sample Size: The document does not specify a sample size for any "test set." The performance data mentioned is from "in vitro bench tests and analyses."
• Data Provenance: The data provenance is "in vitro bench tests and analyses." There is no mention of human clinical data, animal studies, or specific geographic origins (ee.g., country of origin).

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

There is no mention of experts used to establish ground truth for a test set, as the performance evaluation cited is limited to "in vitro bench tests and analyses." This type of testing typically relies on engineering specifications and laboratory measurements rather than expert clinical consensus.

4. Adjudication Method for the Test Set

As no "test set" relying on human interpretation or ground truth requiring adjudication is mentioned, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not mentioned in this 510(k) summary. The provided text details in vitro bench testing for substantial equivalence, not a comparative clinical effectiveness study involving human readers or AI.

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

Not Applicable. This device is a physical medical device (stent system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

For the "in vitro bench tests and analyses," the "ground truth" would be the engineering specifications, material properties, and physical measurements obtained through standardized laboratory testing. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this particular submission.

8. The Sample Size for the Training Set

Not Applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no AI algorithm or training set, this question is not relevant.

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