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The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is I ne Enehein AL SDD Dipercutaneous transluminal angioplasty (PTA) balloon catheter which acts as the 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 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameter of 100mm at stent lengths of 17, 27, 37mm.

The provided text describes a 510(k) premarket notification for a medical device, the LifeStent XL SDS Biliary Endoprosthesis. This submission focuses on demonstrating substantial equivalence to a predicate device rather than a new clinical study involving AI or human readers. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable to this type of submission.

Here's an analysis based on the available information:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be substantial equivalence to the predicate device in terms of design, materials, performance, and intended use. The "reported device performance" refers to the results of in vitro tests comparing the new device to the predicate.

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

• Sample Size for Test Set: Not applicable. The submission relies on in vitro testing for substantial equivalence, not a clinical test set from patients.
• Data Provenance: Not applicable. The data is from internal in vitro testing performed by Orbus Medical Technologies, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. Ground truth from experts is not relevant for this type of in vitro substantial equivalence testing.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.

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

• MRMC Study: No. This is a medical device submission focused on in vitro performance and substantial equivalence to a predicate device, not an AI-assisted diagnostic tool.

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

• Standalone Performance: No. This device is a physical medical implant (stent) and a delivery system, not an algorithm.

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

• Type of Ground Truth: Not applicable in the clinical sense. For in vitro testing, the "ground truth" would be established engineering specifications and measurement standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth for Training Set: Not applicable.

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The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter that acts as the 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 316L stainless steel tube. The stent is inserted percutaneously to the diseased site, and supplied mounted onto a PTA balloon catheter, available with expanded diameters of 8.0 and 9.0mm at stent lengths of 17, 27, 37mm.

Here's a breakdown of the acceptance criteria and study information for the Orbus LifeStent XL SDS Biliary Endoprosthesis, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance acceptance criteria for the new device itself. The "performance data" section primarily lists types of in vitro tests conducted to show equivalence. Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission, which is often about demonstrating equivalence rather than meeting pre-defined numerical thresholds for novel performance claims.

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

• Test Set Sample Size: The document does not specify the sample size used for any of the in vitro tests.
• Data Provenance: The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, since these are described as "in vitro tests" conducted by "Orbus protocols," it implies laboratory testing rather than human clinical trials.

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

• Number of Experts: This information is not provided as the document discusses in vitro tests rather than expert-adjudicated clinical data.
• Qualifications of Experts: Not applicable, as expert ground truth establishment for a test set is not described.

4. Adjudication Method for the Test Set

• Adjudication Method: None described. The evaluation appears to be based on the direct results of in vitro engineering and materials tests, rather than a process requiring expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a medical device (stent), not an AI/software device that would typically involve a multi-reader study. The focus is on physical and performance characteristics compared to predicate devices.

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

• Standalone Performance: Not applicable. This device is a physical medical device (stent), not a software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the in vitro tests mentioned, the "ground truth" would be established by engineering specifications, material standards, and experimental measurements compared against pre-defined acceptance criteria or performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather objective measurement and comparison.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device submission.

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