(377 days)
The LSe Stent Sets are used for temporary internal drainage from the ureteropelvic junction to the bladder.
The LSe Stent Sets are used for temporary internal drainage from the ureteropelvic junction to the bladder. The stents have been Ion Implantation treated for reduced surface friction and enhanced surface energy. The materials used in these devices are stainless steel. TFE, polyprethane, silicone and vinyl. Stainless steel and TFE are widely used in the medical field and biocompatibility is assured. Biocompatibility testing has been performed on the polyurethane, silicone and vinyl and results show the materials to meet the requirements of these tests. The polypropylene does not come into contact with body tissue.
This document is a 510(k) Premarket Notification for a medical device called "LSe Stent Sets." It focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a study with acceptance criteria and device performance results.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable or available within this provided text. This type of 510(k) submission primarily relies on comparing the new device's design, materials, and intended use to existing devices to show it is as safe and effective, rather than conducting a de novo clinical performance study against specific acceptance criteria.
Here's a breakdown of why each point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, not performance metrics against criteria.
- Sample sized used for the test set and the data provenance: Not applicable, as a test set for performance evaluation is not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as a ground truth for performance evaluation is not described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as a test set for performance evaluation is not described.
- 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 a physical medical stent, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is irrelevant.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance evaluation against ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device requiring a training set.
The document states: "The LSe Stent Sets are substantially equivalent to predicate ureteral stents in terms of indications for use, design, construction and materials equivalence." This is the core argument for a 510(k) submission for this type of device. It also mentions "Biocompatibility testing has been performed on the polyurethane, silicone and vinyl and results show the materials to meet the requirements of these tests," but the specific acceptance criteria and results of those tests are not detailed in this summary.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).