(242 days)
The Esophageal Stent System is intended for maintaining esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
The Esophageal Stent System consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part or fully of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for esophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. 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 text is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. Esophageal Stent System (K172813). It details the device, its intended use, comparison to a predicate device, and performance data. However, this document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/algorithm-based medical device.
The questions posed in the request (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth establishment) are relevant to the evaluation of AI/ML-based medical devices, which typically involve performance metrics like sensitivity, specificity, AUC, etc., derived from studies comparing algorithm output to established ground truth.
This 510(k) submission is for a physical medical device (an esophageal stent) and its material and mechanical properties. The "Performance Data" section in the document refers to:
- Biocompatibility Testing: Evaluating the biological safety of the materials used in the stent.
- Device-specific performance tests: Visual inspection, dimension testing, deployment force, expansion force, compression force, corrosion testing, tensile strength, sterility, shelf life, and MR compatibility.
There is no mention of an AI/ML algorithm, or any study design that would involve a "test set," "training set," "ground truth" derived from expert consensus, or "human readers improving with AI assistance."
Therefore, I cannot answer the specific questions about acceptance criteria for an AI device or a study proving its performance from the provided text. The document explicitly states: "No clinical study is included in this submission." This further indicates that the type of performance evaluation relevant to AI/ML devices (which often involves clinical data and observer studies) was not part of this 510(k) submission.
§ 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.”