(60 days)
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).
| Acceptance Criteria (Required Performance) | Reported Device Performance (Study Findings) |
|---|---|
| Biocompatibility: Materials meet applicable biocompatibility standards (e.g., ISO 10993-1:2009, FDA guidance). | All patient contacting materials meet applicable biocompatibility standards. Testing performed with passing results for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Implantation, Chemical Characterization with Toxicological Risk Assessment. |
| Dimensions: Maintain specified dimensions. | Tested and confirmed to meet initial specifications. |
| Tensile Strength: Maintain required tensile properties. | Tested and confirmed to meet initial specifications. |
| Full Functional Tests: Device performs its intended function (facilitating fluid drainage). | Tested and confirmed to meet initial specifications. |
| Packaging Integrity: Packaging maintains sterility and device integrity. | Tested and confirmed to meet initial specifications. |
| Sterility: Achieve and maintain sterility (SAL 10⁻⁶). | Continues to be sterilized by ethylene oxide (EO) to an SAL 10⁻⁶ level. |
| Equivalence in Intended Use/Indications for Use: Same as predicate. | The device has the same intended use (facilitating drainage from kidney to bladder) and same indications for use as the predicate. |
| Technological Characteristics Equivalence: Principles of operation and scientific technology fundamentally unchanged. | Principles of operation are identical to the predicate. The difference is a minor material change to support a lower durometer (softness), which does not change intended use, scientific technology, or indications for use. |
| Safety and Effectiveness: No new issues of safety or effectiveness compared to predicate. | Conclusion: Modified device raises no new issues of safety or effectiveness compared to the predicate. |
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.
§ 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).