(28 days)
The Ureteral Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician.
The Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.
The Ureteral Stents are sterile, single use, disposable devices that provide a lumen that allows fluids to move from the kidney to the bladder. The Ureteral Stents are provided in multiple French sizes and lengths.
The Urinary Diversion Stent Sets are sterile, single use, disposable devices that allow internal drainage from the kidney to an external collection system.
Based on the provided FDA 510(k) clearance letter for the Boston Scientific Corporation's Ureteral Stents and Urinary Diversion Stent Sets (K250824), it's important to note that no study or specific performance criteria are detailed in this document.
This 510(k) is a "Special 510(k) ", which is used when changes to a legally marketed device do not affect its safety or effectiveness. The key takeaway from Section J (Performance Testing) and Section I (Substantial Equivalence) is:
- Changes are limited to labeling updates. The submission explicitly states: "The changes proposed within this bundled Special 510(k) are to the labeling for the proposed devices. There are no changes in design, performance, operating principle, or fundamental technology being proposed within this premarket notification."
- No new testing was required: "Therefore, existing test information/data remains valid for the proposed devices. No additional Verification or Validation testing was required for the changes to the labeling."
- Substantial Equivalence based on existing data: The conclusion reiterates that "Based on the intended use/indications for use, operating principle and comparison of key technological characteristics presented in this premarket notification, it is concluded that the proposed Ureteral Stents and Urinary Diversion Stent Set are substantially equivalent to the predicate device (cleared under K190603)."
Therefore, the document does not contain the information required to populate the sections you requested regarding acceptance criteria and a study proving the device meets those criteria, because no new performance testing was conducted for this specific 510(k) submission.
Here is a table explaining why each of your requested points cannot be answered from this specific 510(k) submission:
| Information Requested | Explanation based on K250824 Document |
|---|---|
| 1. A table of acceptance criteria and the reported device performance | Not applicable. This submission is for labeling changes only; no new performance data or acceptance criteria for new testing are provided. The device relies on prior clearance (K190603) for its performance. |
| 2. Sample sized used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) | Not applicable. No new test set was used for this Special 510(k) as no new performance testing was performed. |
| 3. Number of experts used to establish the ground truth for the test set and qualifications of those experts | Not applicable. No new test set, and thus no new ground truth establishment process, was conducted for this submission. |
| 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set | Not applicable. As no new test set was used, no adjudication method was employed. |
| 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 a physical medical device (stent), not an AI/software device that would typically undergo MRMC studies or assist human readers. Furthermore, no new studies were performed. |
| 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. No new standalone performance testing was conducted. |
| 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) | Not applicable. No new ground truth was established as no new performance testing was conducted. For the predicate device, the ground truth would have been established through methods appropriate for medical devices such as bench testing, biocompatibility, and potentially clinical data from prior predicate devices. |
| 8. The sample size for the training set | Not applicable. This device is not an AI/ML algorithm that requires a training set. No new data generation was part of this submission. |
| 9. How the ground truth for the training set was established | Not applicable. This device is not an AI/ML algorithm that requires a training set. |
In summary, the provided 510(k) document (K250824) is a regulatory clearance for minor changes (specifically labeling updates) to existing, already cleared medical devices. It explicitly states that these changes do not require new performance testing, and therefore, it does not contain the details of studies, acceptance criteria, or ground truth establishment that would be present in an original 510(k) submission for a novel device or a device with significant design changes or a software/AI component. The "proof" of meeting acceptance criteria for these devices relies on the data submitted and reviewed for the predicate device (K190603).
§ 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).