(246 days)
The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
The Agile™ Esophageal Stent System is intended for the endoscopic placement of the selfexpanding nitinol stent for maintaining luminal patency in esophageal strictures. The flexible Agile Stent and through-the scope Delivery System allow for stent placement through direct visualization. The Agile™ Esophageal Stent System is supplied sterile.
The Agile™ Stent is a flexible. MR conditional, self-expanding, braided nitinol stent. The proximal and distal ends of the stent have a flare which is larger in diameter than the stent body. The stent wires at each end of the flare are looped. A suture is threaded within the looped ends of both the proximal and distal stent flares to aid in repositioning during initial placement. The proposed Agile Stent is both fully and partially covered in a silicone covering.
The Agile™ Stent comes preloaded and constrained in the delivery system. The delivery system consists of two coaxial shafts compatible with a minimum 3.7mm working channel of a therapeutic gastroscope. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The delivery system has radiopaque and visual markers to aid the user in accurate stent placement. There are three visual markers on the delivery system handle to aid in the placement of the stent under endoscopic visualization and four radiopaque markers on the interior of the delivery system to aid in placement of the stent under fluoroscopic visualization.
The provided document describes the Agile Esophageal Stent System, a medical device intended for maintaining esophageal luminal patency in esophageal strictures. The information does not detail diagnostic or AI/ML-based performance. Instead, it focuses on the engineering and biocompatibility validation of the stent system itself. Therefore, many of the requested fields related to AI/ML model performance, such as MRMC studies, ground truth establishment for training/test sets, and sample sizes for training sets, are not applicable.
Here's an analysis based on the available information:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The acceptance criteria for the Agile Esophageal Stent System are implicitly defined by the successful completion of a series of biocompatibility and bench tests, along with demonstrating substantial equivalence to predicate devices. The study proving the device meets these criteria involved performing these tests and comparing the results to pre-defined specifications or to predicate device performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | MEM Elution Cytotoxicity | Pass |
| Sub-acute (Subchronic)/Intravenous Toxicity | Pass | |
| Guinea Pig Maximization Sensitization | Pass | |
| Intracutaneous Reactivity | Pass | |
| Sub-acute (Subchronic)/Intraperitoneal Toxicity | Pass | |
| Materials Mediated Rabbit Pyrogen | Pass | |
| Ames Mutagenicity | Pass | |
| Acute Systemic Injection | Pass | |
| Mouse Lymphoma | Pass | |
| Analytical Testing (NVR; GCMS; LC-MS; ICPMS; HS-GC-MS) | Pass | |
| Implantation (Intramuscular, 4 weeks) | Pass | |
| Implantation (Intramuscular, 13 weeks) | Pass | |
| Functional Performance (Bench) | Guidewire Passage | Pass |
| Trackability/Pushability | Pass | |
| Deployment and Reconstrainment | Pass | |
| Delivery System Removal | Pass | |
| Immediate Stent Opening | Pass | |
| Delivery System Withdrawal | Pass | |
| Stent Hoop Expansion and Compression Force | Pass | |
| Delivery System Working Length | Pass | |
| Delivery System Outer Diameter | Pass | |
| Visual Transition Zone Length | Pass | |
| Stent Foreshortening | Pass | |
| Final Unconstrained Stent Length | Pass | |
| Stent Flare Length | Pass | |
| Non-Covered Length (Partially Covered Codes Only) | Pass | |
| Stent Covering Length (Partially Covered Codes Only) | Pass | |
| Stent Diameter | Pass | |
| Flare Diameter | Pass | |
| Tip to Inner Member Bond Tensile | Pass | |
| Inner Jacket to Handle Assembly Tensile | Pass | |
| Reconstrainment Band to Inner Jacket Tensile | Pass | |
| Exterior Tube to Handle Bond Tensile | Pass | |
| Inner Jacket to Inner Member Bond Tensile | Pass | |
| Exterior Tube Transition Zone Tensile | Pass | |
| Suture Pull Strength Test | Pass | |
| Corrosion Testing | Pass | |
| Fatigue Testing | Pass | |
| Deployment Accuracy | Pass | |
| Magnetic Resonance Testing | Pass | |
| Comparative Performance (Bench) | Stent Hoop Expansion & Compression Force | Falls within range of predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for each bench test or biocompatibility test. It reports "Pass" for each test, indicating that the tested samples met the pre-defined criteria. The tests are bench tests performed on the device components or complete systems, and biocompatibility tests conducted in vitro and in vivo (e.g., animal models). The provenance of this data is from the manufacturer's (Boston Scientific Corporation) internal testing. These are prospective tests conducted on the newly designed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. This request is relevant for AI/ML validation where expert consensus establishes ground truth for diagnostic accuracy. Given this is a physical medical device (stent), the "ground truth" is established by engineering specifications, material science standards, and biocompatibility guidelines, rather than expert interpretation of medical images or data.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human readers or experts in diagnostic studies to establish a consensus ground truth. This is not relevant for the bench and biocompatibility testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This is a physical medical device (stent), not an AI-based diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (stent), not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Engineering specifications and standards: For mechanical properties, dimensions, deployment accuracy, etc.
- Biocompatibility standards (e.g., ISO 10993): For material safety tests.
- Comparison to predicate devices: For comparative bench testing, the performance of the predicate devices serves as a benchmark for what is considered acceptable.
8. The sample size for the training set
Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI/ML model, there is no training set or associated ground truth.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”