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510(k) Data Aggregation
(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 < peak load of uncoated dilators. | The document states "The peak load during lubricity testing of the hydrophilic coated region of the dilators shall be less than the peak load during lubricity testing of the uncoated dilators." but does not explicitly report the numerical performance or a direct performance statement for this specific test, only states it was performed. It is implied that it met the expected performance as part of overall conclusion. |
| Dimensional Verification | Length = 60 cm ± 1 cm. FEP dilators include handle. Markings legible. Compatible with wire guide. | "Testing performed demonstrated that the test specimens' dimensions are within the specified tolerances. Testing performed demonstrated that the dilator is compatible with the wire guide." "Dilator markings shall be legible, defined as being able to read markings on dilators." (Implied met, as no issues reported and overall conclusion is positive). |
| Radiopacity | Dilators radiopaque in compliance with ASTM F640-12. | "Testing performed demonstrated that the devices are visible in the radiographic image." |
| Biocompatibility | Meets ISO 10993-1 and FDA guidance for cytotoxicity, sensitization, intracutaneous irritation. | "Testing for cytotoxicity, sensitization, and intracutaneous irritation demonstrated the biocompatibility of the subject device." |
| Sterility | Validated consistent with ISO 11135:2014. Residual EO/ECH no greater than ANSI/AAMI/ISO 10993-7:2008(R)2012 limits. | "The established method used to validate the sterilization cycle is consistent with the half-cycle method as described in ISO 11135:2014." "Residual levels of ethylene oxide (EO) and ethylene chlorohydrin (ECH) have been evaluated and verified to be no greater than the maximum limits as specified in ANSI/AAMI/ISO 10993-7:2008(R)2012." |
| Packaging Integrity | Meets criteria after simulated distribution per ASTM D4169-16 and AAMI/ISO 11607-1:2006/(R)2015. | "Packaging integrity testing after simulated distribution of these packaging materials has been performed on a worst-case representative device. Simulated distribution testing was performed according to ASTM D4169-16. All test methods are as recommended in Annex B of AAMI/ISO 11607-1:2006/(R)2015." (Implied met, as no issues reported and overall conclusion is positive). |
Since the document does not discuss an AI/ML or diagnostic device, the following points from your prompt cannot be answered from the provided text:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and qualifications.
- Adjudication method for the test set.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
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