Search Results

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:

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).

Ask a specific question about this device

The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

The Tria Soft Ureteral Stent consists of the following:

• Tria™ Soft Ureteral Stent with retrieval line
• Ureteral Stent Positioner
• Pigtail Straightener

Please note: The provided FDA document is a 510(k) clearance letter for a medical device (Tria Soft Ureteral Stent), not a diagnostic AI/ML device. Therefore, the document primarily focuses on demonstrating substantial equivalence to a predicate device through material and performance testing, rather than detailed clinical performance studies typically seen for AI-driven diagnostic tools.

As a result, many of the detailed criteria for AI/ML device performance (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific document or type of device clearance.

However, I can extract and interpret the information that is relevant to the acceptance criteria and the study that proves the device meets them, given the context of a ureteral stent:

Description of Acceptance Criteria and Study Proving Device Meets Criteria (for a Ureteral Stent)

This document describes the 510(k) clearance for the Tria Soft Ureteral Stent, which is intended to facilitate drainage from the kidney to the bladder. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device (Tria Firm Ureteral Stent, K190603). For this type of device, "acceptance criteria" are primarily related to functional performance, safety, and material properties, ensuring the new device performs at least as well as, and poses no new risks compared to, the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical medical device (stent) and not an AI/ML diagnostic, the "performance" is about physical and functional attributes rather than diagnostic metrics (e.g., sensitivity, specificity).

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

• Sample Size: The document does not specify exact numerical sample sizes for each specific test (e.g., how many stents were subjected to tensile strength tests). It generally states that "The modifications to the subject Tria Soft Ureteral Stent have been tested in the same manner as the predicate to ensure compliance to the initial specifications."
• Data Provenance: Not explicitly stated as retrospective/prospective or country of origin in the context of clinical data. The tests are laboratory-based engineering performance and biocompatibility studies conducted by the manufacturer (Boston Scientific Corporation).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable in the context of this device. Ground truth, for this device, is established by engineering specifications, material science standards (e.g., ISO 10993), and regulatory requirements, not by expert interpretation of images or clinical outcomes in the way an AI diagnostic would require.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication is typically used to resolve discrepancies in human interpretation (e.g., multiple readers for a diagnostic image). For physical and biological performance tests, the results are typically quantitative measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This document is for a physical medical implant (stent) and focuses on its material and functional properties, not its interpretive performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• For this device, "ground truth" is defined by:
  • Engineering Specifications: Dimensions, tensile strength, functional characteristics.
  • Biocompatibility Standards: Compliance with ISO 10993-1:2009 and FDA guidance, demonstrated through various in vitro and in vivo tests.
  • Sterilization Standards: Achievement of SAL 10⁻⁶.
  • Predicate Device Performance: The predicate device serves as the benchmark for "acceptable" performance and safety.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve machine learning or a "training set."

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

• Not Applicable. As above, there is no training set for this type of device.

Summary for this specific device type:

The "study" proving the device meets acceptance criteria for this 510(k) clearance is a series of bench testing (engineering performance tests) and biocompatibility testing. The core of the argument for clearance is substantial equivalence to an existing predicate device, demonstrating that the minor material change to achieve a "softer" stent does not negatively impact its safety or performance, and that it continues to function as intended in the same manner as the predicate. The acceptance criteria are largely met by confirming that the device's measured physical properties and biological interactions align with established standards and are comparable to its predicate.

Ask a specific question about this device