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510(k) Data Aggregation
(177 days)
The Stryker Flexible Ureteroscope is indicated for use during minimally invasive urological procedures accessed through natural body orifices and is intended for, but not limited to transurethral examination of the upper urinary tract including the ureter, and kidney and, utilizing additional accessories for various diagnostic and therapeutic procedures.
The Stryker Flexible Ureteroscope is a newly marketed product for Stryker Endoscopy and is based upon technology used in endoscope production and clinical applications for over 30 years. All applicable materials are tested and validated for biocompatibility according to the voluntary standard ISO 10993 "Biological Evaluation of Medical Devices". The cleaning, disinfection, and sterilization methods will be equivalent to those for which the Karl Storz Uretero-Fiberscope is currently validated. The Stryker Flexible Ureteroscope will be electrically isolated from the patient and the physician, will meet safety standards for leakage current, will not present a thermal hazard to the physician, and will meet all applicable safety standards established by EN 60601-2-18: Particular Requirements for the Safety of Endoscopic Equipment.
The provided text describes a 510(k) summary for the Stryker Flexible Ureteroscope. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and detailed performance metrics as would be found for a novel AI/software device.
Therefore, the requested information elements related to AI device performance, such as sample size for test sets, expert ground truth adjudication, MRMC studies, standalone performance, and training set details, are not applicable to this submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Material Biocompatibility: Conformance to ISO 10993 "Biological Evaluation of Medical Devices". | "All applicable materials are tested and validated for biocompatibility according to the voluntary standard ISO 10993." |
| Cleaning, Disinfection, and Sterilization: Equivalent methods to the predicate device. | "The cleaning, disinfection, and sterilization methods will be equivalent to those for which the Karl Storz Uretero-Fiberscope is currently validated." |
| Electrical Safety: Electrical isolation, meeting leakage current standards, no thermal hazard. | "The Stryker Flexible Ureteroscope will be electrically isolated from the patient and the physician, will meet safety standards for leakage current, will not present a thermal hazard to the physician, and will meet all applicable safety standards established by EN 60601-2-18: Particular Requirements for the Safety of Endoscopic Equipment." |
| Sterilization Standard Conformance: Conformance to EN 550 Ethylene Oxide Sterilization. | "The Stryker Flexible Ureteroscope will conform to the following voluntary standards: EN 550 Ethylene Oxide Sterilization." |
| Overall Safety and Effectiveness: No significant technological differences that raise new issues of safety and effectiveness compared to the predicate. | "There are no significant technological differences between the Stryker Flexible Ureteroscope and the predicate Karl Storz Uretero-Fiberscope. Clinical data and laboratory testing demonstrate that the differences do not raise new issues of safety and effectiveness of the proposed device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The submission relies on "clinical data and laboratory testing" in a general statement to support substantial equivalence, but it does not detail a specific test set, its size, or provenance for performance evaluation in the context of an AI device.
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)
- Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.
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. An MRMC study is not mentioned or implied because this is a physical medical device, not an AI diagnostic/assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For a physical device like an endoscope, "ground truth" typically refers to established engineering standards, biocompatibility testing results, and clinical observations for safety and functionality, rather than diagnostic outcomes from a test set. The document refers to "clinical data and laboratory testing" but does not elaborate on the specific nature or "ground truth" definition within that context.
8. The sample size for the training set
- Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. This information is relevant for AI performance evaluation, which is not the focus of this 510(k) for a physical medical device.
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