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The TiLock Cortical Spinal System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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); tumor; pseudoarthrosis; and failed previous fusion.

The intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine TiLock Pedicle Screw System (K100757). The subject devices differ from the predicate due to the addition of a thread on the distal portion of the screw shank.

This submission presents various device configurations based on surgical approach and patient anatomy, and consists of a Genesys Spine TiLock Cortical Spinal System, which may be implanted via a conventional (open) or over-the-wire procedures.

The Genesys Spine TiLock Cortical Spinal System is comprised of polyaxial screws (solid and cannulated) in various lengths and diameters, lock screws, and rods in various lengths. The TiLock Cortical cannulated polyaxial screws may be implanted via a conventional (open) technique or with an over-the-wire technique. Manual instrumentation for implantation of the system is available for both techniques. The overthe-wire procedure is performed using k-wires and fluoroscopy. The implantable components are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537.

This document is a 510(k) premarket notification for the Genesys Spine TiLock Cortical Spinal System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices.

The key points from the document regarding the device and its equivalence are:

• Device Name: Genesys Spine TiLock Cortical Spinal System
• Regulation Number/Name: 21 CFR 888.3070 – Pedicle screw spinal system
• Regulatory Class: Class III
• Indications for Use: To provide immobilization of spinal segments as an adjunct to fusion for a range of spinal instabilities and deformities in skeletally mature patients (including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion).
• Predicate Devices: TiLock Pedicle Screw System (K100757) and TiLock² Spinal System (K103671 / K152039).
• Device Difference: The subject device differs from the predicates due to the addition of a thread on the distal portion of the screw shank.
• Performance Data: The document explicitly states "Not Required. Detailed FEA analysis show that a new worst-case device was not created." This indicates that no new clinical or performance studies were deemed necessary by the submitter to demonstrate substantial equivalence, relying instead on Finite Element Analysis (FEA) to show that the modification did not create a new worst-case scenario compared to the cleared predicate devices.

Given this, I cannot provide the requested table and study details because the document itself states "Performance Data: Not Required" and relies on FEA rather than empirical testing with acceptance criteria.

To elaborate on why the specific questions cannot be answered from this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states performance data is not required due to FEA analysis.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set data from human subjects or physical device testing is presented. The FEA analysis does not involve a "test set" in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
4. Adjudication method: Not applicable. No adjudication method for a test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable. No empirical ground truth data is presented.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission for the Genesys Spine TiLock Cortical Spinal System relies on a demonstration of substantial equivalence to predicate devices, supported by Finite Element Analysis (FEA) to address the minor design modification (addition of a thread). It does not include information on specific acceptance criteria and performance studies in the way one might expect for a novel device or an AI/ML product.

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