(164 days)
The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Ultraflex Tracheobronchial Stent System is a permanently implanted expandable metal stent designed to serve as an intralumenal support to keep open the inner lumen of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.
The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by a crocheted nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.
The partially covered stent has a single layer of silicone that covers the midsection of the stent. Partially covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The uncovered stents are available with a distal or proximal release system.
The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.
The uncovered stent has one pair of RO markers indicated the approximate locations of the margins of the deployed stent. The partially covered stent has four (4) RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover.
The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.
The provided text does not describe acceptance criteria for a device performance study in the context of diagnostic accuracy, which is typically represented by metrics like sensitivity, specificity, or AUC. Instead, it describes acceptance criteria and testing for the safety of a medical device within a Magnetic Resonance (MR) environment.
Here's an analysis of the provided information based on your request, focusing on what is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for each test in a table format, nor does it provide detailed quantitative results for the device performance beyond stating compliance. However, it implicitly states that the acceptance criteria are compliance with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 20, 2021) | The performance (bench) testing demonstrated that the proposed Ultraflex™ Tracheobronchial Stent Systems comply with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021 and are considered substantially equivalent to the predicate devices. (Page 5) |
List of Tests Performed (as part of demonstrating compliance):
- Magnetically Induced Displacement Force: Tested per ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
- Magnetically Induced Torque: Tested per ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
- Heating by Radio Frequency (RF) Fields: Tested per ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
- Image Artifact: Tested per ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests described are "bench performance testing," implying laboratory-based evaluations of the device itself, not a study involving patient data or human subjects. Therefore, concepts like sample size for a "test set" in the context of diagnostic accuracy or data provenance (country, retrospective/prospective) are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable. The study described is bench testing for MR safety, not a study evaluating diagnostic performance where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable, as it's a bench test, not a study with human adjudication of results.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is bench testing for MR safety. AI assistance is not relevant to this type of testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The performance testing was for the physical device's safety in an MR environment.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" (expert consensus, pathology, outcomes data) as it pertains to diagnostic accuracy studies is not applicable here. The ground truth for the safety testing is established by adherence to the specified ASTM standards and the FDA Guidance for MR safety, which define acceptable parameters for magnetic displacement, torque, heating, and artifact generation.
8. The sample size for the training set
This information is not provided and is not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no training set mentioned or implied for this device.
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal 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.”