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When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

• DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
• Spondylolisthesis .
• Spinal stenosis .
• Fracture/dislocation .
• Failed previous fusion .
• Tumors .

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 - T3) spine.

The use of the polyaxial screws is limited to placement in T1 – T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

The provided text describes a 510(k) summary for the S4 Spinal System and indicates that the device has undergone performance testing. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment typically found in a clinical study report.

Instead, it states:

"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This implies that the device met the general requirements outlined in the FDA's guidance documents for spinal systems, which typically include mechanical and biocompatibility testing. It does not provide the specific "acceptance criteria" or the "reported device performance" in a quantitative manner as requested. It also lacks information on clinical study aspects like ground truth, expert opinions, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or clinical study details based on the provided text. The document is a regulatory submission summary rather than a detailed performance study report.

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