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The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopes, percutaneous, or 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 pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is a "fube-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" (21 CFR 876.4620).

This document is a 510(k) Special Notification for a medical device called the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent. The purpose of this notification is to expand the product line of an already cleared 4 French ureteral stent by adding larger sizes (5, 6, 7, and 8 French).

The document explicitly states: "No non-clinical or clinical performance data are included in this Special 510(k)." This means that no studies proving device performance against acceptance criteria are presented in this document.

Instead, substantial equivalence is established based on the following:

• Design Controls: The development of the new sizes was done in accordance with 21 CFR 820.30, and compliance with other aspects of Quality Systems Regulation (21 CFR 820) was maintained.
• Validation and Verification Activities: These activities were performed to reflect findings of individual risk analysis. They concluded that any differences in the values of attributes for the larger stents were proportional to those of the cleared/predicate 4 French stent (510(k) K082805).
• Technological Characteristics: The larger sized stents are made of the same raw material, have the same composition and radiopacifier, and use the same manufacturing methods, process parameters, design controls, and quality assurance system as the predicate 4 French device.
• Intended Use and Indications for Use: The proposed stents have the same intended use and indications for use as the cleared predicate, with the exception of removing an upper age limit.

Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets these criteria is not available within this document. This submission relies on the substantial equivalence to a previously cleared device, asserting that the new sizes are sufficiently similar in design, materials, manufacturing, and performance characteristics to the predicate device, and thus do not require new clinical or non-clinical performance data to demonstrate safety and effectiveness.

Since no such study is provided, I cannot populate the table or answer the specific questions about sample size, ground truth, expert opinions, or MRMC studies.

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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.

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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