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The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ System is intended for non-cervical pedicle fixation for the following indications: 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 in skeletally mature patients.

When used for hook fixation. The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems includes components made of implant grade titanium alloy (Ti6Al4V ELI; ASTM F136-02A), cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537, and instrumentation made of PEEK (ASTM F2826) and stainless steel per ASTM F899. These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: pedicle (polyaxial) screws, set screws, rods, hooks, instruments, and sterilizer trays. Additionally, cross connector components are available with the Lancer™ Open Pedicle system.

This document is a 510(k) premarket notification for a medical device, specifically the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems. It details the device's indications for use, its classification, and asserts substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.

The information provided in the document pertains to a traditional orthopedic implant, a pedicle screw spinal system, and its regulatory clearance process based on substantial equivalence to previously cleared devices. The "Performance Standards: Torsional Grip and Axial Grip per ASTM F1798" listed under the Predicate Devices section relate to mechanical testing for the physical pedicle screws, not to the performance of an AI/ML algorithm.

Therefore, I cannot provide details for the following requested items because they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

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