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The Cervical PEEK Spacer is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Cervical PEEK Spacer is intended for use at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical PEEK Spacer is intended to be used with a supplemental internal fixation system.

The Cervical PEEK Spacer is a polyetherether cervical interbody fusion spacer. The device comprises a closed annular ring and hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces and expulsion. The device includes a radiopaque marker pin position wall of the device. The device is offered in two footbrints (depth x width, 9.5mm x 15mm), one lordotic angle (7°) and heights ranging from 6mm to 10mm in 1mm increments.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not describe an AI/ML powered device, nor does it contain information about clinical study acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth methods typically associated with such studies.

Instead, this document pertains to a physical medical device, the "OIC Cervical PEEK Spacer," which is an intervertebral body fusion device. The FDA's review determines if it is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performs similarly in non-clinical tests.

The "Performance Testing" section mentions:

• Static axial compression
• Dynamic axial compression
• Static torsion testing per ASTM F 2077-03
• Subsidence testing per ASTM F 2267-04

These are mechanical engineering tests for a physical implant, not clinical trials or diagnostic performance studies for an AI algorithm. The conclusion states that the device was found to have "acceptable mechanical characteristics for the intended uses," but this is based on engineering standards, not clinical performance against acceptance criteria in the context of an AI study.

Therefore, I cannot provide the requested information because the document does not contain data related to an AI/ML powered device or a study structured to meet clinical acceptance criteria for such a device.

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