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510(k) Data Aggregation
(33 days)
The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a stainless steel tube. The subject device is supplied in a length of 11mm and diameters of 5mm and 6mm.
The provided text describes a 510(k) premarket notification for the LifeStent Turbo Biliary Stent System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria for device performance. Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in the document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantitative acceptance criteria for the new device as would be seen in a clinical trial. Instead, the performance assessment is based on demonstrating "substantial equivalence" to predicate devices through various bench tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Materials: Identical to predicate devices | "identical" to predicate devices |
| Performance Properties: Similar to predicate devices | "similar performance properties" to predicate devices; bench testing "performed in a manner substantially equivalent to the predicate devices" |
| Biocompatibility: Similar to predicate devices | "substantially equivalent" to predicate devices |
| Method of Sterilization: Identical to predicate devices | "identical" to predicate devices |
| Packaging: Identical to predicate devices | "identical" to predicate devices |
| Bench Testing (Deployment, Dimensional, Compression Force, Balloon Performance, Stent Deformation, Tensile Strength): Results indicate substantial equivalence to predicate devices. | Results "indicate that the system performed in a manner substantially equivalent to the predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of human subjects or clinical data. The performance evaluation was based on bench testing of the device itself. Therefore, concepts like country of origin for data and whether it was retrospective or prospective are not applicable. The sample sizes for each type of bench test (e.g., how many stents were tested for deployment) are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The evaluation was for a medical device through bench testing, not an AI or diagnostic system requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. There was no "test set" requiring adjudication by experts. The performance was assessed through engineering and physical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the goal is often to measure the impact of an AI adjunct on reader performance. The LifeStent Turbo is a therapeutic device (stent).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation in the context of an algorithm or AI without human-in-the-loop performance was not done. This is not an AI device. The "standalone" performance here refers to the device's physical and mechanical properties demonstrated through bench testing.
7. The Type of Ground Truth Used
For a physical medical device like a stent, the "ground truth" for bench testing typically refers to:
- Engineering specifications and design tolerances.
- Material properties (e.g., stainless steel composition).
- Known performance characteristics of the predicate devices.
- Standardized testing methodologies (e.g., ASTM standards) for evaluating properties like tensile strength or fatigue.
The document states that the bench testing covered deployment testing, dimensional testing, compression force testing, balloon performance testing, stent deformation testing, and tensile strength testing. The "ground truth" for evaluating these tests would be the established engineering and materials specifications for the device and a comparison to the known performance of the predicate devices.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There was no training set for an AI model.
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(11 days)
The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire delivery system. The LifeStent Turbo is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, open lattice design is made by laser cutting an open lattice design into a stainless steel tube. The stent is available in lengths of 12 mm, 18 mm, and 25mm and diameters of 5mm and 6mm.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the Edwards Lifesciences LifeStent Turbo Biliary Stent System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Characteristic | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Deployment Testing | Performed in a manner substantially equivalent to the predicate device. |
| Dimensional Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Compression Force Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Balloon Performance Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Stent Deformation Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Tensile Strength Testing (delivery system joints) | Performed in a manner substantially equivalent to the predicate device. | |
| Material Properties | Materials | Identical or substantially equivalent to the predicate device. |
| Biocompatibility | Biocompatibility | Identical or substantially equivalent to the predicate device. |
| Sterilization | Method of Sterilization | Identical or substantially equivalent to the predicate device. |
| Packaging | Packaging | Identical or substantially equivalent to the predicate device. |
| Intended Use | Palliation of malignant strictures in the biliary tree | Same intended use as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documents do not specify a sample size for a test set. The performance data section (Section 11) states that "Edwards Lifesciences completed bench testing" for various mechanical properties. This implies laboratory testing rather than clinical study with human or animal subjects acting as a "test set" in the common sense for medical devices involving diagnosis or treatment effectiveness.
The data provenance is bench testing, which is laboratory-based and therefore doesn't have a country of origin or a retrospective/prospective designation in the same way clinical data would.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The "tests" mentioned are physical and mechanical bench tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. As mentioned above, the tests are mechanical bench tests, not evaluations requiring human adjudication.
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. The study described is bench testing, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done. This device is a physical medical device (stent and delivery system), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing would be the engineering specifications and established performance characteristics of the predicate device. The goal was to demonstrate "substantial equivalence" of the new device's engineering and performance properties to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is a physical device, and the concept of a "training set" is usually relevant for AI/machine learning models. The stent itself is not a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As explained above, the device is not an AI system, and therefore, there is no "training set" or corresponding ground truth establishment in that context.
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