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Intervertebral Body Fusion

The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is designed for use with autogenous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Partial Vertebral Body Replacement

The NuVasive CoRoent Small Interbody System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The NuVasive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission describes the NuVasive CoRoent® Small Interbody System, which is an intervertebral body fusion device and a partial vertebral body replacement device. Since this is a medical implant, the "performance" is measured by its mechanical integrity and functional equivalence to predicate devices, rather than typical AI/software performance metrics like accuracy, sensitivity, or specificity.

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

This submission does not involve a "test set" in the context of AI or software performance evaluation. The "testing" refers to non-clinical mechanical and material properties testing. The submission does not specify a distinct "sample size" for specific mechanical tests beyond the implication of standard testing methodologies per the referenced ASTM and ISO standards. The data provenance is derived from these non-clinical laboratory tests.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission. Ground truth for mechanical performance is established through standardized engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission requiring adjudication of expert interpretations.

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

Not applicable. This is a medical device (spinal implant) submission. There is no AI component, and thus, no human readers or AI assistance to compare.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This is a medical device (spinal implant) submission. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's "performance" is based on engineering standards and specifications. This includes:

• Material specifications: ASTM F2026, ASTM F136, ISO 5832-3, ASTM F560, ISO 13782 for the PEEK-Optima LT-1, titanium alloy, and tantalum components.
• Mechanical testing standards: ASTM F2077 for static and dynamic axial compression and torsion, and ASTM F2267 for subsidence analysis.
• Comparative analysis: Demonstrated substantial equivalence to the performance of legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission. There is no "training set" for an algorithm. The design and manufacturing processes are informed by existing biomechanical knowledge, engineering principles, and the performance characteristics of predicate devices.

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

Not applicable. There is no training set as this is not an AI/software device. The underlying principles for the device's design and expected performance are established through decades of biomedical engineering research, material science, and clinical experience with similar devices, as well as adherence to recognized industry standards (ASTM, ISO).

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