(269 days)
Surgical indication:
The Vortek® Single Loop Ureteral Stent is intended for use in ureterostomy or vesical replacement in adult and pediatric (adolescents, children, and infants requiring endourological procedure and /or short-term (less than 30 days) drainage of the upper urinary tract.
Endoscopic indication:
The Vortek® Single Loop Ureteral Stent is intended for short-term (less than 30 days) drainage of urine from the upper urinary tract over fistulas or ureteral obstacles in adult and pediatric (adolescents, children, and infants) patients.
Vortek Single Loop Ureteral Stents are self-retaining catheters used to maintain drainage of the upper urinary tract following an intervention on the ureter/bladder or in the case of an obstacle such as calculi or stenosis. The devices collect urine from the kidney for short-term (
The provided text describes information for the K201436 submission to the FDA for the Vortek® Single Loop Ureteral Stent. However, it does not contain specific acceptance criteria or performance results in a structured format that can be directly extracted into a table.
Instead, it lists the types of testing performed to support substantial equivalence and states that "The protocol and results of the provided performance testing to support substantial equivalence are acceptable." This implies that the device met internal acceptance criteria defined for these tests, but the document does not enumerate them or present the specific performance values.
Therefore, I cannot directly populate a table of acceptance criteria and reported device performance from the provided text.
Similarly, much of the other requested information pertains to a study design and results (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) which are typical for clinical trials or AI algorithm validation studies, rather than the biocompatibility and mechanical testing summaries presented here for a ureteral stent.
Below, I will extract what I can based on the text, with clear indications where the information is not provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Not provided | Not provided |
| Sensitization | Not provided | Not provided | |
| Irritation | Not provided | Not provided | |
| Acute Systemic toxicity | Not provided | Not provided | |
| Material-mediated pyrogenicity | Not provided | Not provided | |
| Subchronic toxicity | Not provided | Not provided | |
| Genotoxicity | Not provided | Not provided | |
| Implantation | Not provided | Not provided | |
| Chemical characterization | Not provided | Not provided | |
| Toxicological Risk evaluation | Not provided | Not provided | |
| Mechanical | Flow Rate | Not provided | Not provided |
| Elongation/Yield and tensile strength | Not provided | Not provided | |
| Curl (Loop) Strength | Not provided | Not provided | |
| Shelf Life/Expiration date | Not provided | Not provided | |
| Visual and dimensional testing | Not provided | Not provided | |
| Guidewire compatibility | Not provided | Not provided | |
| Radiopacity | Not provided | Not provided | |
| Magnetic resonance compatibility | Not provided | Not provided | |
| Sterilization | Ethylene oxide cycle | Sterility Assurance Level (SAL) of 10^-6 (implied standard for sterilization) | 10^-6 (The document states "demonstrating a sterility assurance level (SAL) of 10^-6.") **Correction: The document states 10^-9. ** |
| Shelf Life | Package integrity testing | Not provided | Not provided |
| Performance verification | Not provided | Not provided |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided. The document lists types of tests (e.g., cytotoxicity, flow rate) but does not specify the number of units/samples tested for each.
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). The tests are laboratory-based and do not involve patient data in the typical sense for this type of medical device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number and Qualifications of Experts: Not applicable/Not provided. The "ground truth" for these types of tests (biocompatibility, mechanical performance) is typically established by recognized standards, experimental protocols, and calibrated equipment, not by expert consensus on clinical findings.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not provided. This concept is relevant for clinical or diagnostic study designs, not for the laboratory testing of a ureteral stent's physical properties or biocompatibility.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a ureteral stent, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical ureteral stent, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For the biocompatibility and mechanical testing, the "ground truth" implicitly refers to the scientific and engineering principles, material standards (like ISO 10993-1), and industry-accepted test methodologies and their respective endpoints which define acceptable performance. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not provided. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. (See #8).
§ 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).