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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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is to add rod to rod connectors and lateral rod connectors to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

This document describes a 510(k) premarket notification for the Coral™ Spinal System by Theken Spine, LLC. It aims to add rod-to-rod and lateral rod connectors to an already approved system. The submission emphasizes substantial equivalence to existing predicate devices based on design, materials, indications for use, and manufacturing processes.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria. The document is a regulatory submission for a medical device that focuses on demonstrating substantial equivalence to previously approved devices, primarily through comparison of design, materials, and intended use, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The sections below will indicate that the information is not available in the provided document.

Acceptance Criteria and Device Performance Study Information

The provided document is a 510(k) summary for a medical device (Coral™ Spinal System) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results. Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• Information Not Available in the Provided Text. The document does not describe specific acceptance criteria or report performance metrics for the Coral™ Spinal System beyond declaring it substantially equivalent to predicate devices.

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

• Information Not Available in the Provided Text. No test set, data provenance, or sample sizes related to a performance study are mentioned. The submission relies on design, material, and functional comparisons for substantial equivalence.

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

• Information Not Available in the Provided Text. The document does not describe a performance study involving ground truth establishment by experts.

4. Adjudication method for the test set

• Information Not Available in the Provided Text. No adjudication method for a test set is described.

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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system. Performance is assessed through mechanical testing and comparison to predicate devices, not through standalone algorithm performance.

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

• Information Not Available in the Provided Text. No ground truth for a performance study is mentioned as no such study is detailed.

8. The sample size for the training set

• Information Not Available in the Provided Text. No training set is mentioned as the document is not describing a machine learning or AI-based device.

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

• Information Not Available in the Provided Text. No ground truth for a training set is mentioned.

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