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The Stryker Flexible CystoNephroscope is indicated for use during minimally invasive urological procedures through natural body offices or through perculaneous access, and is intended for but not limited to, examining the uning tract and the interior of the kidney, and, using additional accessories, performing diagnostic and therapeutic procedures.

The Stryker Flexible CystoNephroscope is a modification of the currently marketed Stryker Flexible Ureteroscope, with changes to labeling, performance, materials, and intended use. The Stryker Flexible CystoNephroscope is a flexible endoscope with active deflection capability.

This 510(k) summary describes a traditional device submission, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (like sample sizes for test/training sets, ground truth establishment for AI, MRMC, or standalone performance) is not applicable or present in the provided text.

The document primarily focuses on establishing substantial equivalence to a predicate device based on commonalities in materials, performance, and intended use, as per FDA's requirements for traditional medical devices.

Here's an overview of the device and the basis for its clearance as presented in the document:

Device Information:

• Proprietary Name: Stryker Flexible CystoNephroscope
• Common and Usual Name: Endoscope, Cystoscope, Nephroscope
• Classification Name: Endoscope, Cystoscope, Nephroscope
• Intended Use: Indicated for use during minimally invasive urological procedures through natural body orifices or percutaneous access. Intended for, but not limited to, examining the urinary tract and the interior of the kidney, and, using additional accessories, diagnostic and therapeutic procedures.
• Predicate Device: ACMI ACN-2 11001 DD Nephro-Fiberscope (K970427)

Basis for Clearance (Substantial Equivalence):

The Stryker Flexible CystoNephroscope is deemed substantially equivalent to the predicate device in terms of safety and effectiveness. The submission states that it is a modification of a currently marketed Stryker Flexible Ureteroscope, with changes to labeling, performance, materials, and intended use, including the addition of active deflection capability.

The submission also notes: "There are no significant technological or performance differences between the Stryker Flexible CystoNephroscope and the identified predicate devices, nor are there any new questions raised regarding safety or effectiveness that would prevent a finding of substantial equivalence to the identified predicate devices."

The device conforms to voluntary safety standards for endoscopic equipment (ISO 10993 Biological Evaluation of Medical Devices).

Regarding the requested information, which is primarily relevant for AI/ML device studies:

1. Table of acceptance criteria and reported device performance: Not provided for this type of device submission. Acceptance criteria for traditional medical devices like endoscopes relate to their physical and functional specifications (e.g., deflection angles, illumination, material biocompatibility), and these are typically verified through design verification and validation activities, but not usually presented as a table of "performance" metrics in a 510(k) summary in the same way an AI device's clinical performance would be. The clearance is based on substantial equivalence, implying it meets similar performance standards to the predicate.
2. Sample size used for the test set and data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm. This is a physical medical device.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for an AI algorithm is irrelevant here.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone performance study: Not applicable, as "standalone" performance refers to an AI algorithm's performance without human intervention.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided text concerns a traditional medical device (an endoscope) and its 510(k) clearance based on substantial equivalence to a predicate device. The detailed questions about AI/ML specific study design, performance metrics, and data handling are not relevant to this type of submission.

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