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The intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervicothoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows:

• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
• . Spondylolisthesis,
• Trauma (i.e., fracture or dislocation), .
• . Spinal Stenosis,
• Atlanto-axial fracture with instability, .
• Failed previous fusion, .
• Occipito-cervical dislocation, .
• Revision of previous cervical spine surgery, ●
• Spinal tumors. ●

The occipital bone screws are limited to occipital fixation only.

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

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for purposes of anchoring an OCT construct, and are not intended for treatment of thoracic conditions. Screws are not intended to be placed in the cervical spine.

The Certex OCT Spinal Implant System consists of screws, hooks, rods, plates and connectors. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patient anatomy. The Certex OCT Spinal Implant System components are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided clean but non-sterile.

Here's an analysis of the provided text regarding the Certex™ OCT Spinal Implant System's acceptance criteria and the study proving its performance:

Important Note: The provided document is a 510(k) summary for a spinal implant system. These types of devices are typically evaluated based on their mechanical and biocompatibility performance and their substantial equivalence to a predicate device, not on accuracy metrics like those used for AI/diagnostics. Therefore, many of the requested fields (e.g., sample size for test set, number of experts, MRMC studies, ground truth for training) are not applicable to this type of device and study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" as this is a mechanical engineering study, not a clinical study with patient data. The "samples" would refer to the number of physical implant constructs tested, which is not detailed in the summary.
• Data Provenance: Not applicable in the context of patient data. The tests were conducted on physical device components and constructs, likely in a laboratory setting. There is no mention of country of origin for data or whether it was retrospective or prospective, as these terms are for clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to recognized testing standards and measurement protocols, not by expert consensus on clinical data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical testing results are objective measurements against defined standard criteria, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable. This device is a passive spinal implant, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? No.
• Details: Not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this type of device is defined by the acceptance limits and methodology outlined in the cited ASTM (American Society for Testing and Materials) standards (ASTM F2706 and ASTM F1798). These standards dictate how the tests are performed and what constitutes acceptable mechanical performance (e.g., strength, stiffness, fatigue resistance, slip).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical implant, and the performance data presented is derived from mechanical testing against established standards, not from a machine learning model with a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned, there is no "training set" in this context.

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