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The Core Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Core Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Core Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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); tumor; pseudoarthrosis; and failed previous fusion. The Core Hook System can be used in conjunction with Core Pedicle Screw System.

The Core Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system that consists of pedicle screws, rods, hooks, set screws, connectors, and a transverse (cross) linking mechanism. The Core Pedicle Screw System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

This document is a 510(k) Premarket Notification for the Core Pedicle Screw System. It seeks clearance to market the device based on its substantial equivalence to a previously cleared predicate device.

Here's an analysis of the provided information concerning acceptance criteria and studies:

Acceptance Criteria and Device Performance:

The document states: "The subject device is identical to the previously cleared Rexious System in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling." This implies that the acceptance criteria for the Core Pedicle Screw System are met by demonstrating its identical nature to the predicate. The "reported device performance" is implicitly that it performs the same as the predicate device.

Study Information:

The document explicitly states: "Non-clinical testing was not performed as part of this submission."

Therefore, regarding the specific questions about studies:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set was used for this submission. The device is being cleared based on substantial equivalence to a predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No test set was used.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set was used.
4. 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. This is a medical device (spinal fixation system), not an AI diagnostic tool. No MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No original ground truth was established for this submission. The "truth" is established by the predicate device's prior clearance and demonstrated safety and effectiveness.
7. The sample size for the training set: Not applicable. No algorithm was trained.
8. How the ground truth for the training set was established: Not applicable. No algorithm was trained.

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