(224 days)
The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant turnors only, and occlusion of concurrent esophageal fistula.
The stent is provided pre-loaded in the delivery system. The stent is made up of several segments. The main frame is woven by Nitinol wire, and the connecting part is PTFE connecting loop. The stent with this segmented structure can flexibly conform to the curvature of the human body lumen, thereby reducing the stimulation of the end to the lumen. Silicone membrane applied to the stent covers the complete body of the stent along both flanges, which means the segmented esophageal stent is a fully covered stent. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. The covering is intended to reduce the risk of tissue ingrowth and provides a occlusion for esophageal fistulas. To aid in visibility under fluoroscopy there are 4 bands at either end of the stent and 2 bands at the middle of the stent. The stent has a retrieval loop which can be used to reposition the stent during the initial placement procedure if desired. The delivery system allows for desheathing to deploy the stent and recapturing the stent during stent deployment. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.
The provided document is a 510(k) Summary for the Segmented Esophageal Stent System (K182910), which is a medical device. This document describes the device's technical characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, not its performance against specific acceptance criteria in a clinical study for an AI/CADe device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document, as it pertains to a different type of medical device submission (510(k) for a physical stent, not an AI/CADe device).
The document focuses on demonstrating that the new stent device is substantially equivalent to a previously cleared predicate device (CHOOSTENT™ Covered Esophageal Stent, K072094) based on material, design, manufacturing, and general performance testing (bench tests and biocompatibility).
Although I cannot provide the requested information in the format of an AI/CADe device study, here's a summary of the performance data included in this 510(k) submission, which is primarily focused on demonstrating safety and efficacy for a physical implantable device:
Performance Data Summary (for the physical stent device):
The Segmented Esophageal Stent System underwent various performance tests to demonstrate its substantial equivalence to the predicate device.
Biocompatibility Testing:
- Stent Biocompatibility Testing:
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogen
- Salmonella Reverse Mutation Test
- In Vitro Mammalian Cell Gene Mutation Test
- Muscle Implant
- Delivery System Biocompatibility Testing:
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
Device-Specific Performance Testing (Bench Tests):
- Visual Inspection
- Dimension Testing
- Deployment Force Testing
- Expansion Force Testing
- Compression Force Testing
- Corrosion Testing
- Tensile Strength Testing
- Sterility Testing
- Shelf Life Testing
- MR Compatibility Testing
Compliance Standards:
- ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process"
- ISO 11135 "Sterilization of Health Care Products-Ethylene Oxide-Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices"
- FDA's biocompatibility guidance, Use of International Standard ISO-10993-7, "Biological Evaluation of Medical Devices-7: Ethylene Oxide Sterilization Residuals"
- Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses issued April 28th, 1998 (specifically "VIII Performance testing-Bench")
Conclusion of Testing:
The testing performed demonstrated that the proposed device and predicate device are equivalent in terms of performance characteristics relevant to their intended use (maintaining esophageal luminal patency).
Clinical Study:
No clinical study was included in this submission.
Regarding your specific points (and why they cannot be answered from this document):
- Table of acceptance criteria and reported device performance: Not applicable for this type of submission. The document relies on equivalence to a predicate device, not predefined performance metrics for an AI/CADe system.
- Sample size for test set and data provenance: No test set of medical images/data to assess AI performance. The "test sets" would refer to physical prototypes for bench testing.
- Number of experts for ground truth and qualifications: Not applicable. Ground truth as typically understood for AI/CADe devices (e.g., expert consensus on image findings) is not relevant here.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This assesses human reader improvement with AI, which is irrelevant for a physical stent.
- Standalone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable, as there's no AI model being trained.
- How ground truth for training set was established: Not applicable.
§ 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.”