(127 days)
The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
The Esophageal TTS Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare). The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.
The provided text is a 510(k) summary for the Esophageal TTS Stent. It describes the device, its intended use, and a comparison to predicate devices, along with performance data. However, it explicitly states that no clinical data or animal testing were performed to establish substantial equivalence.
Therefore, the study that proves the device meets acceptance criteria is not a clinical study involving human or animal subjects, but rather bench testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "All samples met their acceptance criteria, demonstrating that when manufactured to specification, the device functions as intended and can be found substantially equivalent to the predicate device." However, the specific acceptance criteria for each test (e.g., a specific force range for the Deployment Force Test) are not detailed within this document. Only the types of tests conducted are listed.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Deployment Test | Not specified | Met acceptance criteria |
| Deployment Force Test | Not specified | Met acceptance criteria |
| Expansion Force Test | Not specified | Met acceptance criteria |
| Compression Force Test | Not specified | Met acceptance criteria |
| Dimensional Test | Not specified | Met acceptance criteria |
| Tensile Strength Test (Introducer) | Not specified | Met acceptance criteria |
| Corrosion Test | Not specified | Met acceptance criteria |
| Packaging Adhesive Force Test | Not specified | Met acceptance criteria |
| MR Compatibility | Not specified | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
- Sample size: The document states that bench testing was conducted on "both the 22mm diameter size and the 220cm length" of the device. It does not provide a specific number of units tested for each test.
- Data provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Taewoong Medical Co., Ltd., which is based in Korea. This is a retrospective evaluation of the device performance during its development and prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device's substantial equivalence was established through bench testing, not a clinical study requiring expert assessment of patient data.
4. Adjudication method for the test set
Not applicable, as this was not a clinical study involving human judgment. The outcome of the bench tests would have been objective measurements against predetermined (but not specified in this document) specifications.
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 is a medical device (stent) and not an AI/software product, so an MRMC study and AI assistance are not relevant to its performance evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the bench testing would be the engineering specifications and design requirements for the device. The tests validated that the manufactured device performed in accordance with these established technical criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve machine learning or a "training set" in the context of AI.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.”