Search Results

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™ Minimally Invasive 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 posterior, non-cervical pedicle, and non-pedicle fixation, the Lancer™ Open Pedicle Screw System is indicated for the following: 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. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors on the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems include implant components made of implant grade titanium alloy (Ti-6Al-4V ELI; ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainless steel (ASTM F899/A564) and aluminum (ASTM B221). 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: polyaxial pedicle screws, set screws, rods, instruments and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes connector and hook components.

The provided text describes a medical device, the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems, and its substantial equivalence submission to the FDA. It does not describe an AI/ML device or a study comparing its performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving a device meets acceptance criteria in an AI/ML context. The document focuses on the mechanical and material equivalence of a surgical implant system to previously cleared predicate devices, as assessed through non-clinical (mechanical) testing.

Here's why the requested information cannot be found in the provided text:

• AI/ML Device: The "Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems" are physical surgical implants (pedicle screws, rods, connectors) used for spinal stabilization. They are not AI/ML devices that perform diagnostic, predictive, or assistive functions involving data analysis.
• Acceptance Criteria (for AI/ML): The document discusses "Substantial Equivalence" based on "intended use/indications for use, materials, design features, operational principles, and levels of attachment" and mentions non-clinical (mechanical) testing. These are not acceptance criteria for an AI/ML model's performance (e.g., sensitivity, specificity, AUC).
• Study Proving Device Meets Acceptance Criteria (for AI/ML): The "Non-Clinical Evaluation" describes mechanical testing (Static Compression-Bending, Dynamic Compression-Bending, and Static Torsion tests per ASTM F1717). This is a purely physical performance evaluation, not a study involving test sets, ground truth, expert readers, or sample sizes relevant to AI/ML performance.
• Other AI/ML related questions: All other points in your request (sample size for test set, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size, training ground truth) are specifically applicable to the evaluation of AI/ML algorithms and are therefore not present or relevant in this document.

In summary, the provided text describes a traditional medical device (spinal implants) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already-cleared predicate devices through mechanical testing, not through AI/ML performance evaluation.

Ask a specific question about this device