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ALL WIN Ureteral stents are intended to temporarily facilitate drainage of urine from kidney to bladder by trained physician. The recommended target population is adults and pediatrics. The indwelling time should not exceed thirty (30) days.

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The provided text is an FDA 510(k) clearance letter for various ureteral stents. It primarily details the regulatory process, product classification, and general controls applicable to these medical devices. It does not contain information on acceptance criteria or studies proving the device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text. The document is a regulatory communication, not a performance study report.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a premarket submission detail that includes the performance data.

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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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The Applied Medical Pediatric Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL) in patients 2 years of age and older. The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.

The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.

The Applied Medical Pediatric Ureteral Stent is substanually equvalant to its predicates devices the Cook Sof-Flex Pediatric Double Pigtail Stent and the Applied Medical Ureteral Stent in design methodology, principle of operation and clinical utility. The device introduces no new safety or effectiveness issues when used as instructed.

The provided text describes a 510(k) summary for a medical device, the Pediatric Ureteral Stent, and its substantial equivalence to predicate devices. It outlines the performance tests conducted but does not provide detailed acceptance criteria values or specific device performance results in a numeric format. It also does not mention any studies involving human readers, ground truth establishment for a test or training set, or sample sizes related to AI/algorithm development.

Therefore, I can extract the information primarily related to the performance tests and the general nature of the comparison, but much of the requested information (especially points 2-9) is not present in the provided text.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document states that performance tests were selected based on the FDA guidance document "Guidance for the Content of Premarket Notifications for Ureteral Stents". It lists the types of characteristics tested but does not provide specific numerical acceptance criteria or the reported device performance values.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the text. The document refers to "predicate device (Cook Sof-Flex 3F Pediatric Ureteral Stent) and in the Applied Medical devices" being tested, implying physical testing of medical devices, not data sets for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the text. The context is for a physical medical device, not an AI or image analysis device that would require expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the text, as it's not relevant for the type of device and testing described.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in the provided text. This document describes a traditional 510(k) for a physical medical device, not an AI/ML-driven device.

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

This information is not applicable as the device is a physical ureteral stent, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as the device is a physical ureteral stent. For the performance tests listed (Flow rate, Elongation, Tensile Strength, Curl Strength, Coefficient of Friction), the "ground truth" would be the direct physical measurement of these characteristics according to established test methods.

8. The sample size for the training set

This information is not applicable as the device is a physical ureteral stent and not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is a physical ureteral stent and not an AI or machine learning model.

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