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The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.

The Pilling Weck 2-Piece Take-Apart Instrumentation are endoscopic instruments, which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle. The devices have reusable handles that accommodate inserts, that can be rotated 360 Degrees during use. Both devices include insulated and noninsulated handles, and accommodating shafts. In the Pilling Weck device there is included a flushing port to facilitate cleaning. All Pilling Weck device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral part of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button.

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies or acceptance criteria for the new device.

The document mainly describes:

• The submitter's information.
• The device's name and classification.
• The predicate device.
• A description of the Pilling Weck 2-Piece Take-Apart Instruments.
• The intended use of the device.
• A comparison of the technological characteristics of the new device to the predicate device to establish substantial equivalence.

Therefore, I cannot fill out the requested table or answer the questions related to studies, sample sizes, expert qualifications, or ground truth.

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