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The TiLock 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 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Genesys Spine TiLock Pedicle Screw System is comprised of polyaxial screws (standard and cannulated) and monoaxial screws in various lengths and diameters, lock plugs, cross-links, tulips and rods in various lengths. The Til ock System only allows the placement of 5.5 mm titanium rods. The TiLock cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the system is available for both conventional and minimally invasive procedures. The minimally invasive procedure is performed using k-wire and fluoroscopy, which allows the implanting surgeon to employ two smaller incisions rather than a longer midline incision.

The provided document describes the Genesys Spine TiLock Pedicle Screw System and its 510(k) submission for substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-driven medical device.

Instead, the "acceptance criteria" for this type of medical device (a pedicle screw system) are typically met through demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing. The document states that "Mechanical test results demonstrate that the minor differences do not impact device performance as compared to the predicate."

Here's a breakdown of the requested information based on the provided text, noting where specific details are not applicable or not present for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of human data. For mechanical testing, the "sample size" refers to the number of test articles (pedicle screws) subjected to the tests. This specific number is not provided in the document.
• Data Provenance: The data provenance is from non-clinical mechanical testing, performed in a lab setting, not from human clinical studies or retrospective/prospective data collection from patients.

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

• Not applicable. This device is cleared based on mechanical performance tests against established ASTM standards and comparison to predicate devices, not on diagnostic accuracy requiring expert ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No expert adjudication process is described for this type of device submission.

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

• Not applicable. This is a medical implant (pedicle screw system), not an AI-driven diagnostic device.

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

• Not applicable. This is not an AI algorithm.

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

• Ground Truth for Mechanical Performance: The "ground truth" or reference for mechanical performance is established by the specifications and pass/fail criteria defined within the ASTM F1717-04 standard for spinal implant constructs, and by comparison to the performance of the predicate devices. Mechanical properties like stiffness, fatigue strength, and torsional resistance are measured against these standards and previous devices.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a training set.

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

• Not applicable. This device does not involve machine learning or a training set.

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