(222 days)
The BONASTENT™ Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistula.
The Bonastent™ Esophageal Stent is a covered, self-expanding tubular prosthesis designed to maintain patency of esophageal strictures caused by malignant tumors. The Bonastent™ Esophageal stent is pre-loaded on a delivery device. The delivery device is placed over a guide-wire and through the working channel of an endoscope to deliver the stent. The delivery device is available in two sizes: 5mm and 6mm diameter. The stents are made of Nitinol wire, and are designed to prevent stent migration due to peristaltic motion and tumor in-growth. The stents are available in a variety of diameters and lengths.
The provided text is a 510(k) summary for the Bonastent™ Esophageal Stent. It describes a medical device and its equivalency to predicate devices. However, this document does not contain acceptance criteria or a study that directly proves the device meets specific performance criteria in the way typically expected for a diagnostic AI or imaging device.
Instead, this document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, primarily through performance testing and comparison of technical characteristics and intended use. The performance testing mentioned is "carried out per FDA document 'Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses'" to establish this equivalence, rather than to meet a set of predefined acceptance criteria for a novel performance claim.
Therefore, the following information, based on the provided text, will be limited and will reflect that the device approval is based on substantial equivalence, not on fulfilling detailed standalone performance metrics in a clinical study as requested.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence and performance testing to FDA guidance, explicit "acceptance criteria" and "reported device performance" in terms of clinical outcomes (e.g., sensitivity, specificity, accuracy) are not defined or provided in this document. The "performance data" mentioned refers to engineering and bench testing to demonstrate equivalence to predicate devices, not clinical efficacy metrics.
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance |
|---|---|
| None explicitly stated as quantitative clinical performance metrics (e.g., sensitivity, specificity, F1 score). | "Performance testing was carried out per FDA document 'Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses' to determine the equivalence of the Bonastent™ Esophageal Stent Systems to the predicate devices and to verify the safety and effectiveness." |
| "The Bonastent™ Esophageal is substantially equivalent to the legally marketed predicate devices mentioned above." | |
| "Substantially equivalent to the legally marketed predicate devices" | Demonstrated through comparison of technical characteristics (e.g., material, design, radiopaque markers, retrieval lassos, reduced delivery device diameter) and "Performance testing" per FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes a medical device (esophageal stent) and its regulatory approval based on demonstrating substantial equivalence to already approved predicate devices. It does not refer to a "test set" of clinical cases or data for evaluating performance of a diagnostic algorithm in the way indicated by the prompt's questions. The "performance data" refers to bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. See point 2.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
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 device is an esophageal stent, not an AI or imaging diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an esophageal stent, not an AI or imaging diagnostic device.
7. The Type of Ground Truth Used
Not applicable. See point 2. The concept of "ground truth" as typically applied to diagnostic algorithm evaluation does not apply here. The "truth" for this submission is whether the device meets the safety and effectiveness criteria as defined by FDA guidance for esophageal prostheses and is substantially equivalent to predicate devices. This is established through engineering testing and design comparisons.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (esophageal stent); it does not describe an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.”