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The CorticaLINK Fusion System is intended for noncervical 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 systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700) and Cobalt Chromium (CrCo) per ASTM F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).

The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by LinkSPINE, Inc., as well as the instructions provided by the Autoclave manufacturer.

This document is a 510(k) premarket notification for a medical device called the "CorticaLINK Spinal Fusion Platform." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study that proves the device meets specific acceptance criteria through a performance study.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment cannot be fully addressed from the provided text because these elements are not present in a 510(k) for a device like this, which relies on substantial equivalence to a previously cleared predicate.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" assessment focuses on the modifications substantially meeting established criteria for the cleared parent device.

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

The document describes a submission for demonstrating substantial equivalence, not a clinical trial with a "test set" of patients or data in the typical sense. Therefore:

• Sample size for test set: Not applicable (no test set of clinical data described).
• Data provenance: Not applicable (no specific clinical data provenance mentioned for a new study). The comparison is primarily based on device characteristics and the predicate.

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

Not applicable. As there's no described clinical "test set" requiring ground truth establishment by experts for performance evaluation, this information is not provided. The submission focuses on engineering and material equivalence.

4. Adjudication method for the test set

Not applicable. There is no described test set of clinical cases or data requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. This is a 510(k) for a spinal fusion platform, which typically demonstrates substantial equivalence through mechanical testing and comparison of design/materials, not through MRMC studies.

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

Not applicable. This device is a physical medical implant (spinal fusion platform), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The type of ground truth used

Not applicable. There is no described clinical study or algorithm where "ground truth" (e.g., pathology, outcomes data) would need to be established for performance evaluation. The "ground truth" in this context refers to the characteristics and performance of the predicate device to which the new device is being compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical implant, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical implant and does not involve AI/ML or a training set.

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