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The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

• degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation);
• spinal stenosis;
• curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• pseudoarthrosis;
• and failed previous fusion.

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws. rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

The provided document is a 510(k) premarket notification for the CorticaLINK Spinal Fusion Platform. It describes the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices. However, it does not contain acceptance criteria or detailed results of a study demonstrating the device meets specific performance criteria in a clinical context that would require ground truth, human readers, or AI.

This document describes a medical device called the "CorticaLINK Spinal Fusion Platform," which is a system of implants used to stabilize the spine. The performance data provided is for non-clinical mechanical testing of the device's components (screws, rods, and locking caps), not a study involving human or AI performance.

Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study proving the device meets those criteria, as the information required (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets) is not present in the given text.

The document only states that the device was tested mechanically according to ASTM standards and found to be substantially equivalent to predicate devices for its intended use, indicating sufficient strength.

Here's what I can provide based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions ASTM F1717-14 standards, which are general test methods for spinal implant constructs. However, specific numerical acceptance criteria (e.g., minimum bending strength in Nm) and the corresponding reported device performance values are not detailed in this summary. It only states that the results "show that the strength of the CorticaLINK Spinal Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Missing Information (Not Available in the Document):

2. Sample size used for the test set and the data provenance: Not applicable, as this was mechanical testing, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable, as this was mechanical testing, not a study requiring ground truth for diagnostic or expert agreement.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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