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The Applied Medical Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.

The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.

The Applied Medical Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.

The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.

The provided 510(k) summary for the Applied Medical Ureteral Stent (K040760) does not contain a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This means that the regulatory submission relies on the existing safety and effectiveness of previously approved similar devices, rather than presenting a new clinical study with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not applicable or ascertainable from this document.

Here's an attempt to answer the questions based on the available information regarding substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As per the 510(k) process for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. There are no explicit, quantifiable acceptance criteria or reported device performance metrics in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) submission relies on substantial equivalence, not a direct clinical study with a "test set" and a defined sample size for performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for a test set is not established in a substantial equivalence submission.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a ureteral stent, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of device and were not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for a substantial equivalence claim is the established safety and effectiveness of the predicate device(s) based on their existing regulatory approvals and usage history. No specific type of ground truth (e.g., pathology, outcomes data) is generated for the new device in this type of submission.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device and does not involve a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this type of device, ground truth establishment for it is irrelevant.

In summary, the K040760 submission for the Applied Medical Ureteral Stent demonstrates that the device is "substantially equivalent" to predicate devices and introduces no new safety and effectiveness issues. This is a common regulatory pathway for many medical devices, where detailed clinical studies with explicit acceptance criteria and performance metrics (as typically seen in AI device submissions) are not required.

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