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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of the Malibu adjustable cross connector from SeaSpine Inc. to the Coral™ Spinal System. Cross connectors are used to connect the bi-lateral rods of a spinal construct to add torsional rigidity. The cross connectors are available in two styles, straight and contoured, the different styles offer the surgeon options intraoperatively. The straight cross connector offers the surgeon a low profile compared to the surrounding construct. The contoured cross connector offers surgeons an option that is slightly higher in profile but provides additional clearance between the cross connector and the spinal construct.

The information provided describes a medical device submission (K120047) for the Coral™ Spinal System and its expansion with the Malibu adjustable cross connector. It focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and mechanical testing, rather than presenting a study of device performance against specific clinical acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and the study proving adherence cannot be directly addressed from the provided text, as they pertain to clinical or functional performance. The document primarily describes mechanical performance tests to establish substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present in the document:

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

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified for the mechanical tests.
• Data Provenance: N/A (mechanical tests, not clinical data)

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

• N/A (Ground truth is not relevant for mechanical performance testing establishing substantial equivalence.)

4. Adjudication method for the test set

• N/A (Adjudication is not relevant for mechanical performance testing establishing substantial equivalence.)

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

• MRMC Study: No.
• Effect Size: N/A (This device is a spinal fixation system, not an AI-assisted diagnostic tool.)

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

• No. (This device is a spinal fixation system, not an algorithm.)

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

• The "ground truth" for the device's performance is its ability to meet the mechanical standards outlined in ASTM F-1717. This is based on engineering and physical testing standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• N/A (This pertains to mechanical testing and substantial equivalence, not a machine learning model's training set.)

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

• N/A (Not applicable for this type of submission.)

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