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510(k) Data Aggregation
(483 days)
pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is used to facilitate temporary internal urinary drainage from is kidney to the bladder and stenting of the ureter in a pediatric patient no less than 2 years old and not more than 12 years old. The stent may be placed endoscopically, percutaneously, or using open surgical techniques. The stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.
The Q Urological Corporation pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is substantially equivalent to several predicate devices including: the Sof-Fiex Pediatic Double Pigtail Ureteral Stent (Cook Urological), the Sillouette Pediatric Ureteral Stem (Applied Medical Resource), the PANAMEX Ureteral Stent (Kingston Technologies) and the Aquasilque Ureteral Stent (American Medical Systems). Differences between the predicates and the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent are the profile of the anchorage and the stent material. The anchorage section of the stent Urological Corporation is radiopaque. The composition of the stent material has been used before in predicate devices. For the pAguaMedicina Structural Hydrogel Pediaric Ureteral Stent this material has been processed by a proprietary method which delivers equivalent technological characteristics.
The provided text describes a 510(k) premarket notification for a medical device, specifically the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth for AI algorithms is not directly applicable or present in this document.
However, I can extract the relevant information pertaining to the device's performance testing as described for its 510(k) submission, even though it's not structured around "acceptance criteria" and "AI performance" in the way your prompt defines them.
Here's an analysis based on the provided text, addressing your points where possible, and noting when data is not available or relevant to this type of regulatory submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for the device's performance in the typical sense of a target metric for an AI algorithm. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices. The "acceptance" is implied by favorable comparison.
| Performance Metric | Reported Device Performance |
|---|---|
| Anchorage Force | "The anchorage method withstood a significantly greater force before coming dislodged" compared to several predicate devices. |
| Elongation and Tensile Strength | Testing was conducted, and "the results compared favorably to those of the predicate devices tested." |
| Flow Rate | Testing was conducted, and "the results compared favorably to those of the predicate devices tested." |
| Biocompatibility | Tested "in accordance with the suggestions of ISO 10993 for prolonged exposure." The stent material composition has been used before in predicate devices, and the proprietary processing "delivers equivalent technological characteristics." |
| Radiopacity | The anchorage section of the stent is radiopaque. (No comparative statement is made, but radiopacity is a functional characteristic). |
| Equivalent Technological Chars. | The proprietary processing of the material "delivers equivalent technological characteristics" compared to the material in predicate devices. |
| Intended Use | Has the "same intended use as the predicates." |
| Technological Differences/Safety | "Has no technological differences which raise new questions of safety and effectiveness, and it is at least as safe and effective as the predicates." (This is a conclusion drawn from the comparative testing and analysis, not a direct performance metric). |
| Clinical Equivalence (Pediatric Use) | "Predicate stents for pediatric patients have been cleared for the same size as the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent" (implies a similar sizing and suitability for the pediatric population, though not a direct performance metric of the device itself). This device is cleared for pediatric patients no less than 2 years old and not more than 12 years old. |
| Implantation Duration | Stent should not be implanted for more than 30 days, and is not intended as a permanent indwelling device. (This is an indication for use/limitation, not a performance metric demonstrating equivalence, but important for its safe use). |
2. Sample sizes used for the test set and the data provenance
The document refers to "bench performance testing" using "several predicate devices." It does not specify the number of stents (sample size) used for each test (anchorage force, elongation, tensile strength, flow rate) or for the predicates.
- Test Set Sample Size: Not specified.
- Data Provenance: The document implies in-house or contracted laboratory bench testing. No country of origin for data is mentioned, as it's not human subject data. The testing is retrospective in the sense that it's comparing the new device against existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this 510(k) submission. This is a medical device for internal drainage, not an AI diagnostic tool requiring expert consensus for images or clinical data as ground truth. The "ground truth" for this device's performance would be the direct measurements from the bench tests (e.g., force required to dislodge, flow rate).
4. Adjudication method for the test set
Not applicable. This is not an AI diagnostic study involving human interpretation that requires adjudication.
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 is a medical device (ureteral stent), not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in its primary function or regulatory submission.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is derived from direct bench testing measurements (e.g., force, flow rate, material properties) and comparison against established performance characteristics of predicate devices. For biocompatibility, it's compliance with ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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