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The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System via rod to rod connector and transitional rod.

The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semireduction partially screw, straight rod, curved rod, transitional rod, set screw, hooks and accessories that can be used via an open surgical approach.

The provided text is a 510(k) summary for the LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily for mechanical performance and material compatibility, rather than the performance of an AI/ML powered medical device that would have specific acceptance criteria for algorithm performance.

Therefore, the information required to answer your specific questions about acceptance criteria for an AI/ML powered device and the study that proves the device meets the acceptance criteria (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

This document describes a medical device, which is a spinal fixation system, and its premarket notification to the FDA. The "acceptance criteria" here refers to the FDA's regulatory acceptance for substantial equivalence, not performance metrics of a diagnostic or AI-powered analytical tool. The "performance testing" mentioned (Section 7) is mechanical testing to ensure the device components meet engineering and material standards, not the evaluation of an algorithm's accuracy or clinical utility.

In summary, this document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML powered device.

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