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The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, when used as a pedicle screw fixation system, the CapLOX II Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Captiva Spine CapLOX II Spinal System is a top-loading spinal fixation system consisting of polyaxial pedicle screws, cannulated polyaxial pedicle screws set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy. The purpose of this submission is to add additional screws to the pedicle screw system.

The provided 510(k) summary for the Captiva Spine CapLOX II Spinal System focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than clinical performance studies with acceptance criteria based on metrics like sensitivity or specificity. Therefore, many of the requested data points related to clinical or AI/algorithm performance are not applicable to this submission.

Here's a breakdown of the information that is applicable and a note on what is not:

Acceptance Criteria and Device Performance:

Study Information:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not applicable. This submission relies on engineering analysis (FEA) and comparison to predicate devices, not clinical performance data from a test set of patients or cases.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. No ground truth establishment by experts for a test set of clinical images/data is mentioned. The evaluation is based on engineering principles and comparison to existing devices.

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

   • Not applicable. No test set requiring adjudication is mentioned.

4. 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 not an AI/software device, and no MRMC study or assessment of human reader performance with or without AI assistance was conducted.

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

   • Not applicable. This is a spinal implant system, not an algorithm or AI device.

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

   • Not applicable. For this type of orthopedic implant, "ground truth" would typically relate to mechanical testing standards and successful clinical history of the predicate devices. The submission points to "Verification activities including FEA and engineering analysis" and "Documentation provided demonstrates that the Captiva Spine CapLOX II Conclusion: Spinal System is substantially equivalent to predicate devices." This implies that the 'truth' for evaluation is adherence to engineering principles and established performance characteristics of predicate devices, rather than clinical outcomes or diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable. No training set is mentioned as this is not a machine learning or AI device.

8. How the ground truth for the training set was established:

   • Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Captiva Spine CapLOX II Spinal System meets acceptance criteria is a technical and engineering analysis comparing the subject device to legally marketed predicate devices. This is characteristic of a 510(k) submission for mechanical devices, where the primary goal is not to prove new clinical efficacy or diagnostic accuracy but to demonstrate "substantial equivalence" to a device already on the market.

The "study" involved:

• Verification activities: These included Finite Element Analysis (FEA) and general engineering analysis. These analyses would assess the mechanical properties, stress distribution, and overall design integrity of the new components (additional screws) to ensure they perform equivalently to the existing components and predicate devices.
• Comparison to predicate devices: The submission explicitly states the subject device is "substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles." This comparison forms the core of the "proof" for a 510(k) submission.

In essence, the "acceptance criteria" were met by demonstrating through engineering data and direct comparison that the CapLOX II Spinal System performs as safely and effectively as the predicate devices for its stated indications.

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