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The Long Medium PALMAZ-SCHATZ™ Balloon-Expandable Stent is a stainless steel, multi-articulated, slotted tube with nominal lengths of 42mm (PS424), 56mm (PS564), and 78mm (PS784) and an expansion range of 6-10mm. The Stents are intended for palliation of malignant neoplasms in the biliary tree. The Stents are provided unmounted to be crimped onto commercially available Cordis Opta 5™ Catheters which have been qualified by Cordis for stent delivery. The Stent is expanded via inflation of the balloon catheter and deployed. Upon expansion, the Stent forms a strong open lattice in a diamond pattern. The expanded Stent conforms to the inner luminal surface of the bile duct. The ability of the Stent to palliate malignant neoplasms is based upon the ability of the metallic structure of the Stent to plastically deform when the balloon is inflated and maintain its expanded state.

AI/ML Overview

The provided text describes the 510(k) summary for the Long Medium PALMAZ-SCHATZ™ Balloon-Expandable Stent. This document details the device, its intended use, technological characteristics, and nonclinical performance testing. It is a premarket notification for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for a novel AI device.

Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in relation to an AI system, along with specific questions like "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," and "If a multi reader multi case (MRMC) comparative effectiveness study was done," is not applicable to the provided document. The 510(k) summary describes a physical medical device (a stent), not an AI algorithm or software.

However, I can extract the nonclinical performance parameters and their reported outcomes, which serve as the "acceptance criteria" for this physical device as demonstrated through qualification testing.

Here's a breakdown based on the provided text, adapted to best fit the original request's structure:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Parameter Studied for Qualification)	Reported Device Performance
Inflation time	Samples were fully expanded to the nominal diameter within the allotted time period.
Balloon burst	Mounted stents did not modify the catheter's labeled maximum burst pressure.
Crossing profile	A 7F sheath is required for 6mm diameter balloons with mounted stents and an 8F sheath is required for 8mm and 10mm diameter balloons with mounted stents.
Distension	All stents reached their nominal diameter within the recommended pressure.
Deflation time/deflatability	All balloons with mounted stents deflated within the allotted time period. The presence of the stent did not cause any interference with balloon deflatability.
Stent retention	All samples met or exceeded internal criteria for stent retention.
Recoil and Length	The stent remains within its nominal diameter after recoil. Lengths were measured to determine stent length at each expanded diameter (for labeling purposes).
Radial Force	The stent will not collapse within the clinically relevant range.
Percent Open Area	All stent sizes have an open area of 80-90% in their expanded diameter range.
MRI Compatibility	The subject devices were found to be MRI compatible.
Fatigue/Corrosion	No cracks or other metallurgical defects resulted from fatigue testing.

Regarding the other questions, they are not applicable as this document describes a physical medical device, not an AI/software device.

2. Sample sized used for the test set and the data provenance: Not applicable. The document mentions "samples" for testing but does not specify sample sizes for each test in a dataset context, nor data provenance like country of origin or retrospective/prospective. These are engineering/material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical characteristics is established through engineering measurements and established material science tests, not expert interpretation in the way it's used for AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the physical stent's performance is based on direct physical measurements, engineering specifications, and established biocompatibility/material science standards.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this kind of device.
9. How the ground truth for the training set was established: Not applicable.

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