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The PRIMUS™ GPS™ Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

AI/ML Overview

The provided text describes a Premarket Notification (510(k)) Summary for the PRIMUS GPSTM Biliary Stent System. This summary indicates that the device is a modified version of a previously cleared stent and delivery system.

Here's an analysis of the acceptance criteria and the study as requested, based on the provided text:

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

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Palliative treatment of malignant neoplasms in the biliary tree.	Remains the same as the predicate device.
Materials	Compatibility and suitability for the intended use.	Remains the same as the predicate device.
Technological Characteristics	Design and functionality of the stent and delivery system. Specific modification: increased cell length of the stent; combined design features from predicates for the delivery balloon catheter.	Substantially equivalent to the predicate device, with described modifications.
Performance (Bench Testing)	Mechanical integrity, expansion characteristics, and other relevant physical properties.	Performance testing (bench) further supports a substantial equivalence claim.
Safety and Effectiveness	Device is safe and effective for its intended use.	The collective evidence (intended use, materials, technological characteristics, and performance testing) provides assurance that the PRIMUS™ GPSTM Biliary Stent System meets the requirements considered acceptable for the intended use.

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

The document primarily discusses bench testing for performance evaluation. It does not mention any clinical or human subject testing. Therefore, there is no information about a "test set" in terms of patient data, sample size, or data provenance (country, retrospective/prospective).

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

Not applicable. As no human subject testing or clinical data analysis is mentioned, there is no discussion of experts establishing ground truth for a test set.

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

Not applicable. There is no mention of a test set involving human data that would require an adjudication method.

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. The device described is a physical medical device (a biliary stent system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

Not applicable. This device is not an algorithm. Performance was evaluated through bench testing.

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

For the bench testing, the "ground truth" would be the established engineering specifications and performance standards for biliary stents. This would involve objective measurements and comparisons against predefined criteria for mechanical properties, dimensions, and functionality.

8. The sample size for the training set

Not applicable. The device is a physical medical device, not an AI model requiring a training set of data.

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

Not applicable. No training set is involved for this type of device.

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