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The Bioplate® ZIP™ Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilized bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Bioplate® ZIP™ Craniotomy Fixation System consists of two circular disks, in a parallel configuration, that are connected by an internal, serrated post. The devices will be available in several sizes with disk diameters in the range of 10mm to 18mm to be used for varying cranial closure techniques. The implant devices will be manufactured from 6AI4V titanium alloy material.

The provided text is a 510(k) summary for the Bioplate® ZIP™ Craniotomy Fixation System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving new safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets them in the way a clinical trial would.

Instead, the document focuses on:

• Device Description and Intended Use: The Bioplate® ZIP™ Craniotomy Fixation System is described as consisting of two circular disks connected by an internal, serrated post, made from 6AI4V titanium alloy. Its intended use is to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
• Predicate Devices: Several predicate devices are listed, including systems from Stryker Instruments, Synthes (USA), Walter Lorenz Surgical, Ikonos Corp., and Aesculap, Inc., as well as a previous Bioplate® ZIP™ system (K013050).
• Substantial Equivalence: The core argument of the 510(k) is that the new system has the "same indications for use as the predicate devices" and that "all of the technical characteristics... are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided 510(k) summary. The FDA's letter explicitly states that they "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies a comparison to existing devices rather than a de novo clinical study to meet predefined acceptance criteria for novel safety or efficacy claims.

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