(15 days)
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.
| Acceptance Criteria (Characteristic) | Reported Device Performance (Not quantified in the document) |
|---|---|
| Flow rate | Tested in predicate and Applied Medical devices |
| Elongation and Tensile Strength | Tested in predicate and Applied Medical devices |
| Curl Strength (Coil retention) | Tested in predicate and Applied Medical devices |
| Coefficient of Friction | Tested in predicate and Applied Medical devices |
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.
§ 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).