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The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system. The DUR™-8 and DUR™-8E are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Both the DUR™-8 and DUR™-8E are non-sterile, reusable flexible fiberoptic endoscopes. They feature a lubricious polyurethane outer covering, a patented cable compensation system, a patented torque-stabilization shaft construction, duel light transmission, a rotating light post, luer lock irrigation and biopsy ports, and a detachable light guide. The optics, illumination carriers, working channel, manufacturing methods and specifications of both devices are identical.

The DUR™-8E is a modification of the DUR™-8 designed to provide the clinician with greater control over the distal tip of the endoscope. The DUR™-8 has a passive deflection section, while the DURTM-8 Elite has an actively controllable section proximal to the primary active deflection section. A secondary deflection control lever has been added to the head of the DURTM-8 Elite.

The provided text is a 510(k) summary for the ACMI USA Series™ DUR™-8 and DUR™-8 Elite Flexible Ureteropyeloscope and Choledochoscope. It does not contain information about acceptance criteria or a study proving the device meets said criteria as requested in the prompt.

The document primarily focuses on:

• Device Identification: Proprietary name, common name, classification name.
• Sponsor Information: Contact details, date prepared.
• Predicate Devices: A list of previously cleared devices to which this device claims equivalence.
• Device Description: Detailed physical and functional characteristics of the DUR™-8 and DUR™-8E, highlighting the differences between the two models (active vs. passive deflection).
• Intended Use: Specific medical procedures and anatomical areas for which the devices are indicated.
• Technological Characteristics and Substantial Equivalence: The basis for claiming equivalence to predicate devices (similarities in indications for use, design, materials, technological, and operational characteristics).
• FDA Clearance Letter: Official communication from the FDA granting 510(k) clearance, confirming substantial equivalence to predicate devices, and outlining regulatory responsibilities.
• Indications for Use Statement: A formal statement of the device's intended uses.

Therefore, I cannot extract the requested information from the provided text. The prompt asks for details related to acceptance criteria, device performance metrics, sample sizes, expert qualifications, and study methodologies which are not present in this 510(k) summary. These types of details are typically found in validation reports, design control documents, or specific performance studies, which are not part of this submission summary.

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