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The Guidant MEGALINK™ Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent designed to be placed percutaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is for single use only and is a permanent implant. The Guidant MEGALINKTM Biliary Stent is fabricated from a single piece of 316L medical grade stainless steel tubing which conforms to ASTM Standard F-138-92 Grade 2. The stent is comprised of a scries of multiple rings with multiple links aligned along a common longitudinal axis. Each ring is approximately 2 mm long. The number of rings per stent is dependent upon the length of the stent, i.e., 8 rings for 18 mm, 13 rings for 28 mm and 17 rings for 38mm. The nominal strut thickness is .0060" and the nominal strut width is .00575". The stent is balloon-expandable with an expansion range from 6 - 10 mm in diameter for the 58 mm length stents. The stent is designed to be hand crimped onto a percutaneous transluminal angioplasty (PTA) balloon catheter for stent delivery and deployment in the biliary tree. The stent may be post dilated with a PTA balloon catheter to ensure good stent deployment. The maximum post dilatation diameter for the 58 mm stent length is 11 mm.

The Guidant MEGALINK™ Biliary Stent is a medical device designed for the palliation of malignant strictures in the biliary tree. The provided document, K991032, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study for novel device performance. However, based on the available information, we can infer some aspects.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "In vitro bench testing was performed to demonstrate that the Guidant MEGALINK Biliary stent met the acceptance criteria and performed similar to the predicated evices. The functional tests met product specifications."

This indicates that specific "product specifications" served as acceptance criteria. Unfortunately, the document does not enumerate these criteria or provide quantitative performance results. It only broadly states that the device "met the acceptance criteria" and "performed similar to the predicated devices."

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

• Sample Size: Not specified. The document only mentions "In vitro bench testing."
• Data Provenance: Not specified. It's likely that the testing was conducted by Guidant Corporation (manufacturer) in a laboratory setting, but the country of origin is not explicitly stated. The testing was retrospective in the sense that the device had already been manufactured for testing, but it wasn't a retrospective analysis of clinical patient data.

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

There is no information about experts establishing ground truth for the in vitro bench testing. Bench testing typically relies on predefined engineering specifications and measurement techniques, not expert consensus on qualitative observations like in clinical imaging studies.

4. Adjudication Method for the Test Set

Not applicable for in vitro bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts.

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

No. The document explicitly states the study was "In vitro bench testing." This is not a clinical study involving human readers or comparative effectiveness with or without AI assistance. This device predates widespread AI in medical devices by decades.

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

No. This device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

For the in vitro bench testing, the "ground truth" was established based on:

• Engineering Specifications: Predefined design parameters, material standards (e.g., ASTM F-138-92 Grade 2), and functional requirements for stent performance (e.g., expansion diameter, strut dimensions).
• Predicate Device Performance: The device's performance was evaluated against that of the predicate devices (Guidant MEGALINK™ Biliary Stent K983075), implying that the predicate's known performance served as a benchmark for equivalence.

8. The Sample Size for the Training Set

Not applicable. The device is a physical stent, not an AI algorithm requiring a training set.

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

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

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The Guidant MEGALINK™ Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent designed to be placed percutaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The Guidant MEGALINK™ Biliary Stent is designed to be hand crimped onto a PTA balloon delivery catheter and expanded by balloon inflation. Two crimping 0.87 mm (0.035") and 0.35mm (0.014") are included to provide innuel member support of the delivery catheter during stent crimping. Once the Guidant MEGALINK™ Biliary Stent is mounted onto the PTA balloon delivery catheter it is intended to be delivered and deployed in the biliary tree.

The provided text describes a 510(k) premarket notification for a medical device, the Guidant MEGALINK™ Biliary Stent. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with established acceptance criteria and performance metrics.

Therefore, much of the information requested in your prompt (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study details, training set details) is not applicable or explicitly provided in this type of regulatory document.

Here's a breakdown based on the available information:

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

• Not Applicable / Not Provided: The document does not specify quantitative acceptance criteria or detailed reported device performance for clinical outcomes. The regulatory pathway here is a 510(k), which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy against defined metrics through a de novo study. The "Performance Data" section states that safety and effectiveness were demonstrated through "nonclinical bench tests and analyses," but specific criteria and results are not detailed.

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

• Not Applicable / Not Provided: No clinical "test set" from human data is described in this 510(k). The performance data cited is from "nonclinical bench tests and analyses."

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)

• Not Applicable / Not Provided: As there is no clinical "test set" described, there is no mention of experts establishing ground truth for such a set.

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

• Not Applicable / Not Provided: No clinical test set or adjudication method is described.

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 / Not Provided: This device is a physical medical implant (a stent), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

• Not Applicable / Not Provided: This device is a physical medical implant, not an algorithm.

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

• Not Applicable / Not Provided for clinical data: For "nonclinical bench tests and analyses," the "ground truth" would typically relate to engineering specifications, material properties, and mechanical performance (e.g., expansion diameter, radial strength, fatigue resistance). The document does not elaborate on these specifics.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no mention of a "training set" as this is not an AI/algorithm device submission.

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

• Not Applicable / Not Provided: There is no mention of a "training set."

Summary of Relevant Information from the Document:

• Study That "Proves" Device Meets Criteria: The document states, "The safety and effectiveness of the Guidant MEGALINK™ Biliary Stent has been demonstrated through data collected from nonclinical bench tests and analyses." This is the "study" referred to, though no specific details of these tests are provided beyond their nonclinical nature.
• Acceptance Criteria & Performance (Implicit): The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance is implicitly accepted if it is deemed equivalent to the predicate.
  • Predicate Device: JJIS PALMAZ™ balloon-expandable Stent for the Biliary System (K905720 and K911581).
  • Basis for Equivalence: "The design, materials, method of delivery and intended use features of the Guidant MEGALINK™ Biliary Stent are substantially equivalent with regard to these features in the predicate device... The Guidant MEGALINK™ Biliary Stent incorporates similar design, components, method of deployment, materials and intended use of the predicate device..."
• Intended Use/Indication: Palliation of malignant strictures in the biliary tree.
• Technological Characteristics: Range of expanded lengths (18 to 38 mm) and diameters (6 to 10 mm).
• FDA's Determination: The FDA reviewed the 510(k) notification and determined the device is "substantially equivalent" for the stated indications for use, subject to specific labeling limitations (regarding vascular use and prominent display of biliary use).

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