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The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL® Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL® Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The PEEK PREVAIL® Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft.

The PEEK PREVAIL® Cervical Interbody device implant is manufactured from PEEK Optima LT1® and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

The provided text is a 510(k) premarket notification for a medical device, the PEEK PREVAIL® Cervical Interbody Device. It describes the device, its intended use, and states that it is substantially equivalent to a previously cleared device (K094042).

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report or a performance validation document.

Therefore, I cannot provide the requested information, particularly items 1-9, as this type of detail is not present in the provided text. The document states:

• Substantial Equivalence: "Documentation was provided which demonstrated the subject intervertebral devices to be substantially equivalent to PEEK PREVAIL® Cervical Interbody Device components previously cleared in K094042 (S.E. 06/30/2010)."
• Non-Clinical Testing: "The subject and predicate PEEK PREVAIL® Cervical Interbody Device are identical in terms of indications for use, intended use, performance specifications, and technological characteristics. Cleaning and sterilization assessments have been performed to provide the appropriate instructions for the use of the PEEK PREVAIL device."
• Conclusions: "The information above demonstrates equivalence and supports a determination of substantial equivalence between the subject and predicate PEEK PREVAIL® Cervical Interbody Device."

This regulatory pathway (510(k)) often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring new, extensive clinical trials to establish de novo acceptance criteria and prove performance against them. The "non-clinical testing" mentioned here likely refers to bench testing to confirm material properties, mechanical strength, and sterility, consistent with the predicate device, rather than a study against a specific set of clinical performance acceptance criteria.

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