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The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:

• instability caused by trauma or fracture; .
• instability associated with correction of cervical lordosis and kyphosis deformity; ●
• . instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic . malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative . · disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.

1. Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided document describes mechanical and other non-clinical performance testing. It does not mention a "test set" in the context of clinical data, human subjects, or data provenance from specific regions. The testing was conducted on samples of the Reliance Anterior Cervical Plate System itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. This was a non-clinical performance study involving mechanical testing and assessments of material properties, not a study requiring expert clinical review to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth. This document describes non-clinical performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a spinal implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical implant, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this performance study was established through standardized mechanical testing protocols (ASTM F-1717) and assessments of material properties (sterilization, biocompatibility). The comparison was made against the performance of legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This document describes non-clinical performance testing of a physical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as no training set for a machine learning model was used.

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