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The NuVasive CoRoent Single Tab System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Single Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screw.

The NuVasive CoRoent Single Tab System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) summary for the NuVasive CoRoent Single Tab System, which is an intervertebral body fusion device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting acceptance criteria for device performance based on a new study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as well as details about sample sizes, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

Here's why and what information is available:

1. A table of acceptance criteria and the reported device performance:

• Not provided. The 510(k) pathway for this device relies on demonstrating substantial equivalence through bench testing, not on establishing and meeting new clinical performance acceptance criteria.
• The document states: "The results demonstrate that the subject CoRoent Single Tab System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable/Not provided. No clinical test sets or patient data were used for this 510(k) submission. All testing was bench-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. No human expert ground truth was established as there were no clinical studies.

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

• Not applicable/Not provided. No clinical test set.

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/Not provided. This is a physical medical device (intervertebral body fusion system) and does not involve AI, human readers, or image interpretation.

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

• Not applicable/Not provided. This device is a physical implant, not an algorithm. The document explicitly states: "This device does not contain software or electrical equipment."

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

• Not applicable/Not provided. Ground truth, in the clinical sense, was not established as there were no clinical studies. For bench testing, the "ground truth" is typically the established engineering and materials standards (e.g., ASTM standards).

8. The sample size for the training set:

• Not applicable/Not provided. No training set was used as this device does not involve machine learning or AI.

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

• Not applicable/Not provided. No training set was used.

Summary of available "Performance Data" from the document:

The device underwent bench testing to demonstrate substantial equivalence to predicate devices. The specific tests performed were:

• Static and dynamic axial compression and compression shear per ASTM F2077.
• Wear debris testing per ASTM F2077, ASTM F1714, and ASTM F1877.

The document explicitly states: "No animal or clinical studies were conducted."

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