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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: desc 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, 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); 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 include implant components made of implant grade titanium alloy (Ti-6AI-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 cross connector and hook components.

The provided FDA 510(k) clearance letter does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the manner you've outlined for diagnostic AI/CADe systems. This document is for a physical medical device (pedicle screw systems) and focuses on substantial equivalence to predicate devices, primarily through engineering analysis rather than clinical performance metrics typically associated with AI/CADe.

Therefore, many of the requested fields cannot be filled from the provided text. I will indicate where information is not available.

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. The evaluation was based on engineering analysis, not a clinical test set with patient data for diagnostic performance.
• Data Provenance: Not Applicable (no patient data used for this type of evaluation).

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

• Not Applicable. No diagnostic ground truth was established as this was an engineering evaluation of a physical implant.

4. Adjudication method for the test set

• Not Applicable. No test set requiring adjudication was used.

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 physical implant device, not an AI/CADe system, so an MRMC study is not relevant.

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

• Not Applicable. This is a physical implant device, not an algorithm.

7. The type of ground truth used

• For this device, the "ground truth" or basis for evaluation would be established engineering principles, material science specifications (e.g., ASTM standards for implant-grade titanium and cobalt chrome), and potentially a biomechanical comparison to the predicate devices, rather than clinical outcomes or expert consensus on diagnosis.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/CADe system for this physical implant.

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

• Not Applicable. There is no "training set" or corresponding ground truth in the context of an AI/CADe system for this physical implant.

Summary of the document's relevance to your request:

The provided document is an FDA 510(k) clearance letter for a physical medical device (pedicle screw systems) which involves expanding the available sizes of existing cleared devices. The "study" mentioned is an engineering analysis to demonstrate that the new sizes do not represent a "new worst case" compared to the predicate devices and maintain substantial equivalence. This is fundamentally different from the performance evaluation of AI/CADe devices, which involve clinical accuracy metrics, ground truth establishment, and often multi-reader studies.

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