(276 days)
The Dornier CASCADE Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic 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 ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.
The Dornier CASCADE Ureteral Stents are sterile, single-use devices. The stents are available in 4.9 to 8.0 French (Fr) diameter, with lengths ranging from 14.0 to 32.0 centimeters (cm). The stents are constructed of a thermoplastic polyurethane elastomer. The base polyurethane material is compounded with BaSO4 to render the stent radiopaque under x-ray fluoroscopy.
Drainage holes extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A monofilament tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The CASCADE Ureteral Stent includes a pigtail straightener, a small polymer tube to aid in placement over a wire guide. The pigtail straightener is removed prior to use. The CASCADE Ureteral Stents are labeled for a maximum 30day indwell time.
The stents are packaged into a pre-formed tray and sealed within a Tyvek pouch. The individually sealed Tyvek pouches are labeled with identification labeling and then packaged into a corrugated shipping box. The packaged stents are sterilized by a contract sterilizer using ethylene oxide.
The provided text is a 510(k) summary for the Dornier CASCADE Ureteral Stent. It describes the device, its indications for use, and the studies conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria in a format applicable to evaluating AI/ML models.
The document states: "All testing was found to be acceptable and bench performance testing comparable to the predicate device." This is a general statement of compliance, not a detailed report of acceptance criteria and performance data for a particular device function.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies are not present in this regulatory document.
However, I can extract the information that is available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific numerical acceptance criteria or reported device performance values. It generally states that "All testing was found to be acceptable and bench performance testing comparable to the predicate device." The types of tests performed are listed, implying that the device met the requirements of these tests.
Summary of available information for Section 1:
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Sterilization validation requirements | Found to be acceptable |
| Shelf life, including packaging validation and functional performance testing requirements | Found to be acceptable |
| Biocompatibility requirements (cytotoxicity, skin sensitization, skin irritation, acute systemic toxicity, material-mediated pyrogenicity, genotoxicity, implantation studies, chemical characterization) | Found to be acceptable for stent and pusher |
| Bench Performance Testing requirements (visual inspection, dimensional analysis, pigtail retention, suture retention, coefficient of friction, tensile strength, elongation, radiopacity, and flow rate) | Found to be acceptable and comparable to the predicate device |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided in this document. This document pertains to a physical medical device (ureteral stent), not a software or AI/ML device that operates on a "test set" of data in the common sense of the term for AI/ML. The "testing" refers to physical and biological evaluations of the stent itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided in this document. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images) is not relevant for the types of physical and biological tests described for this ureteral stent.
4. Adjudication method for the test set
Not applicable/Not provided in this document. Adjudication methods are typically for evaluating discrepancies in human or AI interpretations of data, which is not what this document describes.
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
No. This document does not mention any MRMC study or AI assistance, as it concerns a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an algorithm or AI performance.
7. The type of ground truth used
Not applicable/Not provided in this document in the context of expert consensus or pathology for data interpretation. The "ground truth" for the physical device would be the validated standards and specifications against which the stent's physical properties and biological interactions were measured (e.g., ISO standards, ASTM standards for material properties, specified biocompatibility limits).
8. The sample size for the training set
Not applicable/Not provided. This concept is for AI/ML models, not for physical device testing.
9. How the ground truth for the training set was established
Not applicable/Not provided. This concept is for AI/ML models, not for physical device testing.
In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/ML device. Therefore, most of the requested information regarding AI/ML model evaluation, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, is not present or applicable. The document confirms that the Dornier CASCADE Ureteral Stent underwent standard sterilization, shelf-life, biocompatibility, and bench performance testing, and was found to be acceptable and comparable to its predicate device.
§ 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).