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The EOI Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine. The EOI Spinal System is limited to non-cervical, pedicle use and is specifically indicated for treatment of one or more of the following acute and chronic instabilities or deformities:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
2. Spondylolisthesis;
3. Trauma (fracture or dislocation);
4. Deformities or curvatures (scoliosis, kyphosis, and/or lordosis);
5. Tumor;
6. Spinal stenosis;
7. Pseudoarthrosis; and/or
8. Failed previous fusion.

The EOI Spinal System consists of polyaxial pedicle screws in varying diameters and lengths, Ø5.5mm straight and pre-bent rods in varying lengths, and cross connectors in adjustable widths to build a spinal construct. EOI Spinal System components are manufactured from implant grade titanium alloy [Ti-6Al-4V ELI] in accordance with ASTM F-136. Instrumentation is also available to facilitate implantation of the device components. The EOI Spinal System can be rigidly locked into a variety of configurations suitable to the patient's unique anatomy. Implant components and instrumentation are provided non-sterily and must be sterilized prior to use. As with all orthopedic implants, all implant components in this system are single-use and should never be reused.

The EOI Spinal System is a pedicle screw fixation system that provides immobilization and stabilization of spinal segments.

Here's an analysis of its acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

Study Information

1. Sample Size and Data Provenance:

   • Test Set Sample Size:
     • Static axial compression bending: n=6
     • Dynamic axial compression bending: n=6
   • Data Provenance: Not explicitly stated, but given that it's mechanical testing of a device, it's typically performed in a laboratory setting. This is a prospective test specifically for this device.

2. Number and Qualifications of Experts for Ground Truth: Not applicable, as this is mechanical performance testing against a standard and comparison to a predicate device, not a diagnostic or clinical study requiring expert review for ground truth.

3. Adjudication Method: Not applicable, as this is mechanical performance testing.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not conducted. This is a pre-market notification (510(k)) for a medical device focusing on mechanical performance and substantial equivalence, not a clinical trial evaluating human reader performance with or without AI.

5. Standalone Performance Study: Yes, a standalone mechanical performance study was done. The device's components were tested according to ASTM F1717 standards.

6. Type of Ground Truth Used:

   • Mechanical Test Standards: The ground truth for mechanical performance was established by adherence to ASTM F1717 standards for static and dynamic axial compression bending.
   • Predicate Device Performance: Substantial equivalence was based on direct comparison of the EOI Spinal System's mechanical properties to those of the previously cleared CD HORIZON Spinal System (K063670).

7. Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. The device design and manufacturing processes are refined based on engineering principles and material science, not machine learning training data.

8. How Ground Truth for Training Set was Established: Not applicable, as there is no training set in this context.

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