(18 days)
The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.
The IntraCoil Stent is a self-expanding nickel-titanium (Nitinol) coil premounted on a delivery catheter. The stent is provided in diameters 4 to 8 mm, and lengths of 40 and 60 mm. The stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms. Upon deployment the stent expands to conform to the bronchial lumen surface.
The provided text is a 510(k) premarket notification letter for a medical device called the "IntraCoil® Peripheral Stent." It details the device's classification, indications for use, and a summary. However, this document does not contain the specific information needed to answer your request about acceptance criteria and a study proving the device meets those criteria.
The document states:
- Device Name: IntraCoil® Peripheral Stent
- Indication For Use: The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.
- Regulatory Class: II, Product Code: JCT, Regulation Number: 21 CFR 878.3720 (Tracheal prosthesis)
- Substantial Equivalence: Claimed to the IntraCoil® Self-expanding Peripheral Stent, K990221/K001257.
- Modification Covered by this 510(k): Addition of the 8 x 60 mm stent.
- Testing Mentioned: "A subset of the in vitro performance tests conducted for K990221/K001257, and relevant to the modification, were repeated for design verification and product validation."
This brief mention of "in vitro performance tests" is the only reference to testing. There is no detailed description of:
- Acceptance criteria and reported device performance table: Not present.
- Sample size, data provenance (test set): Not present. The "subset of in vitro performance tests" implies bench testing, not a clinical study with patients.
- Number/qualifications of experts for ground truth (test set): Not applicable as it's not a clinical study based on expert interpretation.
- Adjudication method (test set): Not applicable.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable as it's not a clinical study requiring ground truth derived from patients/images. "In vitro performance tests" likely refer to engineering measurements and material properties.
- Sample size for training set: Not applicable as this is a physical medical device, not an AI algorithm.
- How ground truth for training set was established: Not applicable.
In summary, the provided document is a regulatory approval letter and a 510(k) summary for a physical medical device. It attests to substantial equivalence based on prior approvals and in vitro (bench) testing, but it does not contain the kind of detailed study information (especially clinical study details, human reader performance, or AI algorithm validation) that your questions are asking for.
§ 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.”