(231 days)
The Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.
The Ureteral Dilators are intended for the dilation of the ureteroscopy or stone manipulation.
The Ureteral Dilator Sets, and each individual Ureteral Dilator, are used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. The Ureteral Dilator Sets are available in one of three sets: a set of 6 dilators, a set of 7 dilators and a wire guide, or a set of 9 dilators and a wire guide. The dilators are manufactured from either radiopaque ethylene vinyl acetate (EVA) or fluorinated ethylene propylene (FEP). Dilators manufactured with EVA are also available with hydrophilic coating. Dilators are also available individually. The wire guide is a stainless steel fixed core wire guide. The Ureteral Dilators and the Ureteral Dilator Sets are sterilized by ethylene oxide and intended for one-time use.
All Ureteral Dilators are manufactured with a length of 60 centimeters and range from 6.0 French to 18.0 French in diameter. The distal end of the dilators is tapered to a 0.040inch diameter endhole with the taper measuring 0.8-2.5 centimeters from the distal end, depending on the device French size. Additionally, the French size of each dilator is stamped at the proximal end.
The stainless steel fixed cored wire guide is manufactured with a diameter of 0.038 inches (0.97 millimeters) and a length of 145 centimeters.
The provided document is a 510(k) premarket notification for a medical device (Ureteral Dilator Sets and Ureteral Dilators). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a clinical or algorithmic study with defined acceptance criteria for a new, unproven technology.
Therefore, the document does not contain the kind of information requested in your prompt, which pertains to studies proving performance against acceptance criteria for an AI/ML or diagnostic device (e.g., sensitivity, specificity, physician improvement with AI assistance, ground truth establishment).
The "acceptance criteria" discussed in this document refer to bench testing for physical characteristics of the dilators, not clinical performance metrics or AI algorithm performance.
Here's why the document doesn't fit your prompt's requirements:
- Device Type: The device is a physical medical instrument (ureteral dilators), not an AI algorithm, diagnostic tool, or imaging system that would typically have performance metrics like sensitivity, specificity, F1-score, or require MRMC studies.
- Submission Type: A 510(k) for this type of device focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness profiles compared to a predicate, often through bench testing and material characterization, rather than new clinical efficacy studies.
- Tests Performed: The tests listed (Tensile, Kink Resistance, Dilator Tip Rollback, Lubricity, Dimensional Verification, Radiopacity, Biocompatibility, Sterility, Packaging Integrity) are all bench tests and material/biological compatibility assessments, not performance studies involving human readers or AI output.
If I were to hypothetically interpret the "acceptance criteria" from the bench testing context within the provided document, here's how it would look, but please be aware this is not what your prompt is asking for in terms of AI/diagnostic device performance:
Hypothetical Table of "Acceptance Criteria" for Ureteral Dilators (Based on Bench Testing from Document)
| Metric/Characteristic | Acceptance Criteria | Reported Device Performance (as stated in document) |
|---|---|---|
| Tensile Testing | Peak load preceding failure ≥ 15 N. | "Testing performed on the dilator shaft per applicable ISO standards demonstrated that the devices met the acceptance criteria." |
| Kink Resistance Testing | Dilator shaft resists kinking at 80° angle. Dilator tip fits over a 0.038 inch guidewire. | "Testing performed per applicable ISO standards demonstrated that the dilator will not kink, buckle or rollback." (Note: The document combines kink resistance and tip rollback in this statement; tip rollback specifically checks for damage during introduction). |
| Dilator Tip Rollback Testing | Tip successfully introduced through urethane membrane without damage (rollback, buckle, kink). | "Testing performed per applicable ISO standards demonstrated that the dilator will not kink, buckle or rollback." |
| Lubricity Testing | Peak load during lubricity testing of hydrophilic coated region |
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).