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The Goblin and Goblin LS Pedicle Screw Systems are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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 and pseudarthrosis

The Goblin and Goblin LS Pedicle Screw Systems are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. The implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136. Various sizes of these implants are available.

The provided text is a 510(k) summary for the "Goblin and Goblin LS Pedicle Screw Systems." It describes a traditional medical device (pedicle screw systems for spinal fixation), not an AI/ML medical device. Therefore, the acceptance criteria and study information typically provided for AI/ML device validation (e.g., sample size for test/training sets, adjudication methods, expert qualifications, MRMC studies, standalone performance, ground truth establishment) are not applicable and are not present in this document.

The performance data section for this device focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, specifically:

• Non-clinical testing performed in accordance with ASTM F1717:
  • Static compression
  • Dynamic compression
  • Static Torsion

This type of testing evaluates the mechanical integrity and performance of the physical implants, which is standard for pedicle screw systems.

Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria from the provided document. The document concerns a hardware medical device.

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