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The AMStent® Tracheobronchial Covered Stent System (AMStent® System) is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.

Peytant Solutions, Inc. developed the AMStent® Tracheobronchial Covered Stent System (AMStent System) to provide patency of the tracheobronchial tree in patients suffering from tracheobronchial strictures produced by malignant neoplasms. Like other nitinol devices that are also used for treating tracheobronchial strictures produced by malignant neoplasms, the AMStent System consists of a self-expanding metallic stent (SEMS) that has a covering material over the interstices of the stent is provided preloaded on a delivery catheter (Figure 1). The difference is that the AMStent covering is made from human-sourced decellularized amniotic membrane (DCAM), while the existing stents utilize synthetic cover materials (e.g., polyurethane, ePTFE, or silicone).

The AMStent is an open-cell, self-expanding, nitinol stent (10mm diameter x 40mm length) with a DCAM cover that is attached to the stent with polyethylene terephthalate (PET) sutures. The AMStent is preloaded on a flexible, "pull-back," AMStent delivery catheter. The AMStent delivery catheter is positioned in the tracheobronchial stricture with the assistance of a standard 0.035" guidewire, that is not provided with the AMStent System, under bronchoscopic and / or fluoroscopic visualization. Radiopaque markers are located on each end of the AMStent and on the distal end of the AMStent delivery catheter to facilitate placement.

The provided text describes the AMStent® Tracheobronchial Covered Stent System, a medical device, and its regulatory information, but does not contain information about an AI-powered device or a study demonstrating its performance against acceptance criteria in the context of an AI/human reader comparison.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes, ground truth establishment for a test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details in the context of an AI device.

The document details the non-clinical/bench studies performed for the AMStent® System to demonstrate its safety and effectiveness, which are standard for a medical device of this type. It highlights:

• Biocompatibility: Testing based on ISO 10993-1 demonstrated that patient-contacting materials are biocompatible.
• Shelf-Life: Demonstrated continued intended function over a minimum of 90 days.
• MR Compatibility: Tested per ASTM standards, resulting in an "MR Conditional" label with specific parameters (translational attraction 2 degrees, max temperature rise 3.1℃, artifact 5mm).
• Packaging: Engineering bench testing confirmed packaging integrity.
• Performance/Bench Testing: Included stent deployment, compression and recoil, expansion force, dimensional, fatigue, corrosion, and puncture tests of the DCAM cover. These tests were deemed satisfactory to show the device performs as intended and is safe for use.
• Human Tissue Controls: Detailed process for obtaining and preparing human tissue (DCAM) according to 21 CFR 1271 and CGTP requirements, with risk control measures, material characterization, and lot release.
• Animal Studies: Two GLP-compliant large animal studies (one chronic (average 92 days) and one acute) evaluated in-vivo safety, implantability, migration, systemic effects, removability, and usability. Both met success criteria and supported safety and performance claims. The chronic study showed less stent migration, mucus accumulation, occlusion, and fewer obstructive granulomas compared to a control device, though for a small sample size.
• Clinical Information: Explicitly states "Not applicable. Validation of the AMStent System did not require clinical evaluation in human subjects."

Summary of what the document does provide regarding acceptance criteria and studies (non-AI related):

The document outlines Special Controls (effectively regulatory acceptance criteria) that the device must meet, and then describes the studies that demonstrate compliance.

Special Controls (Acceptance Criteria):

1. Human tissue characterization and infection control measures:
   • Donor eligibility assessment (screening, testing for communicable diseases).
   • Testing of all donor tissue for specific communicable disease agents (HIV, Hepatitis B/C, Treponema pallidum).
   • Material sourcing from registered facilities following specific procedures (environmental monitoring, decellularization, viral inactivation, nucleic acid removal, distinct ID code, quarantine).
   • Material characterization demonstrating consistent meeting of final product specifications.
2. Non-clinical performance testing:
   • Deployment testing (accuracy, repeatability).
   • Compression and expansion forces.
   • Dimensional testing.
   • Fatigue and corrosion testing.
   • MR environment compatibility.
3. Animal performance testing:
   • Chronic study to evaluate device migration, occlusion, and granuloma formation.
4. Biocompatibility: Demonstrated.
5. Labeling: Must include MR compatibility, device/procedure-related complications, summary of bench/in-vivo testing duration, functionality limited to demonstrated performance, and shelf-life.
6. Sterility: Performance data must demonstrate sterility of patient-contacting components.
7. Shelf-life: Performance data must support continued sterility, package integrity, tissue integrity, and device functionality over the identified shelf life.

Studies and Reported Performance (Demonstrating Compliance with Special Controls):

The text does not present performance in a structured table against specific quantitative acceptance criteria for each special control, but rather states that the studies "demonstrated" or "met" the objectives.

• Human Tissue Controls: Process for obtaining/preparing human tissue (DCAM) follows 21 CFR 1271 and CGTP requirements. Risk control measures include donor screening/testing, terminal sterilization. |
  | 2. Non-clinical Performance Testing | - Performance/Bench Testing: Included stent deployment, compression and recoil, expansion force, dimensional, fatigue, corrosion tests, and puncture testing of DCAM cover. Specific testing for nitinol (corrosion, Ni ion release) performed. "Testing was satisfactory to show the device performs as intended and is safe for use."
• MR Compatibility: Tested per ASTM F2052-15, F2213-06, F2119-07 at 1.5T/3T. "MR Conditional" (Translational attraction 2 degrees, max temp rise 3.1℃, artifact 5mm). |
  | 3. Animal Performance Testing | - Animal Studies: Two GLP-compliant studies. Chronic study (avg. 92 days): Evaluated safety, implantability, migration, systemic effects, usability. Met success criteria. Showed "less stent migration, less mucus accumulation and occlusion, and fewer obstructive granulomas relative to a marketed stent" (small sample size). Acute study: Evaluated safety, implantability, removability, usability. Met success criteria. |
  | 4. Biocompatibility | - Biocompatibility: Tested based on ISO 10993-1. "Results of all biological tests demonstrated that the patient contacting materials...are biocompatible." |
  | 6. Sterility | - Sterility Testing: Implied as part of shelf-life testing and manufacturing controls. "Performance data must demonstrate the sterility of patient-contacting components." (No direct results provided beyond this general statement). |
  | 7. Shelf-life | - Shelf-Life: "All testing...has demonstrated continued intended function over a minimum of 90 days." Current shelf life established at 90 days. "Performance data must support the shelf-life by demonstrating continued sterility, package integrity, tissue integrity, and device functionality." |

Since the request is about an AI device's acceptance criteria and study, and the provided text describes a physical medical device (a stent) with no mention of AI, I must state that the vast majority of the requested information is not applicable based on the provided input.

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