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The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.

The Accordion Piccolo's film membrane is attached to a two-part (inner and outer shaft) guidewire and deploys within the lumen of the ureter. The device can be advanced via the working channel of a cystoscope, and advanced under direct vision or fluoroscopy until the tip is proximal to the kidney stone or foreign object. To contain the stone during lithotripsy or entrap a foreign object, the movable core of the guidewire component is advanced by pulling on the handle, which causes the film membrane to deploy within the lumen of the ureter and prevent proximal movement of the stone or object during the surgical procedures. The physician may maintain the film membrane in the deployed position and "sweep" the stone fragments down the ureter and into the bladder or use the deployed film as a "backboard" to prevent migration of the stone fragments into the kidney as he/she removes the fragments with a basket or other device.

I apologize, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification for a medical device called the "Accordion Piccolo Stone Management Device." It describes the device, its intended use, predicates, and some benchtop performance tests.

However, it does not include any information about:

• Acceptance criteria for performance (beyond general safety and effectiveness claims compared to a predicate).
• Details of a clinical study or a test set with specific performance metrics.
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes).
• Training set details or how ground truth for training was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering changes and benchtop mechanical testing, rather than a clinical performance study involving AI or diagnostic accuracy that would require the details you're asking for.

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