Search Results

The IntraStent® Mega™ LD (Large Diameter) Stent - Biliary Indication and the IntraStent® Max™ LD (Large Diameter) Stent - Biliary Indication are intended as a palliative treatment of malignant neoplasms in the biliary tree.

The IntraStent Mega and Max LD Stents are balloon expandable stainless steel stents with an open lattice design. The device is provided unmounted, to be manually crimped onto a noncompliant PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

Medical Device: IntraStent Mega LD and IntraStent Max LD Stents

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify any sample sizes for a human-based test set or any clinical data provenance. The study described is entirely based on bench testing of the devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was a bench test study, not a clinical study involving experts establishing ground truth from patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device modifications and bench testing for substantial equivalence, not clinical effectiveness studies comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical implant (biliary stent), not a software algorithm or AI. The performance reviewed is mechanical/physical, not algorithmic.

7. Type of Ground Truth Used

The "ground truth" for this submission was the performance characteristics, materials, indication for use, and technological characteristics of the predicate devices (IntraStent™ Stent, K991929, and IntraStent DoubleStrut LD, K993904). The modified devices were compared against these established characteristics of the legally marketed predicate devices to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This submission concerns physical medical devices, not an AI or algorithm that would require a training set.

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

Not applicable. There was no training set in the context of an AI or algorithm.

Ask a specific question about this device

The IntraStent™ Biliary Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree.

The IntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is provided unmounted, to be manually crimped onto a noncompliant PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

The provided document describes a 510(k) premarket notification for a medical device, specifically the IntraStent™ Biliary Stent. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials.

Therefore, the study described is not a typical clinical study with acceptance criteria in the usual sense (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the "acceptance criteria" here relate to demonstrating that the new device performs equivalently to existing devices through bench testing.

Here's a breakdown 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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involves "bench tests" and "pyrogenicity testing on a lot to lot basis." For bench tests of medical devices like stents, this typically means a representative number of units from manufacturing lots are tested.
• Data Provenance: Not specified. Bench testing is typically performed in a laboratory setting, and pyrogenicity testing would be performed on manufactured product lots. There is no mention of human clinical data or geographical origin.

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

This type of information is not applicable to this submission. The "ground truth" for substantial equivalence is the performance of the predicate devices. The validation is against engineering and material specifications and the performance of existing, approved devices, not against expert interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. There is no "test set" in the sense of clinical cases requiring adjudication by experts.

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 is not applicable. This submission is for a physical medical device (biliary stent), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

This is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the established performance and characteristics of the legally marketed predicate devices (IntraTherapeutics, Inc. ITI Stent (K980290 & K991929) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFILEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653)). The new device's performance is compared to these benchmarks through bench testing.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

This is not applicable.

Ask a specific question about this device