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The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput 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.

In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are manufactured from Titanium alloy and will be provided non-sterile.

The provided document is a 510(k) summary for the Aesculap S4 Cervical Spinal and Occiput Systems. It describes the device, its indications for use, and a comparison to predicate devices. It also details the performance testing conducted. However, this document does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device, as the Aesculap S4 Cervical Spinal and Occiput Systems are physical medical implants, not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this submission pertains to a physical orthopedic implant system, not a digital health or AI/ML device.

The "Performance Data" section solely refers to non-clinical mechanical testing of the implant system against established ASTM standards to demonstrate substantial equivalence to predicate devices, not clinical performance data or AI/ML specific metrics.

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