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The CapLOX II/TowerLOX Pedicle Screw 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/TowerLOX Pedicle Screw 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 CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and pre-lordosed configurations. The system includes set screws, and rods along with the associated instrumentation to complete the procedure and implant construct.

This submission is for a Special 510(k) for the CapLOX II/TowerLOX Pedicle Screw System. The changes involve adding new rod lengths, new instrumentation, and new cross connector sizes.

Based on the provided information, no new performance testing was required because the changes were considered to be within the scope of the previously cleared predicate devices and did not raise new questions of safety or effectiveness. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "Based on the risk analysis for the proposed changes, no new performance testing is required."
• "Captiva Spine concludes that these changes to the CapLOX II/TowerLOX Pedicle Screw System is substantially equivalent to the predicate with the same name and raises no new questions of safety or effectiveness."

Because no new performance testing was conducted for this specific submission, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not applicable as no new performance testing was conducted.
2. Sample size used for the test set and data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The regulatory review for this special 510(k) focused on demonstrating substantial equivalence to pre-existing predicate devices (K122332, K120292, and K121020) rather than presenting new performance study data.

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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 seements 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 CapLOX II Pedicle Screw System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-55mm. Rods are available in 5.5mm diameter, as either straight rods available in lengths from 30-500mm or precurved rods available in lengths from 30-120mm. The system includes a set screw, tulip heads, a cap and cross connectors to complete the assembly.

1. Acceptance Criteria and Device Performance

The provided document, K120292 for the CapLOX II Pedicle Screw System, describes a Special 510(k) submission for minor changes to an already cleared device. As such, the performance testing focuses on demonstrating that the mechanical characteristics of the modified device are not altered compared to the predicate device.

2. Sample Size for Test Set and Data Provenance

The document states: "New performance testing per ASTM F1798 was completed at an independent laboratory." However, the specific sample size used for this mechanical testing is not explicitly stated within the provided text.

The data provenance is from mechanical testing performed at an independent laboratory, rather than from patient data. Therefore, the concepts of "country of origin of the data" and "retrospective or prospective" do not directly apply in the context of this mechanical performance study.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this submission. The ground truth for this device's performance is established through mechanical testing per a recognized standard (ASTM F1798), not through expert review of clinical cases or data.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication by multiple parties in the way clinical data might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device and submission. This device is a pedicle screw system, and the submission addresses mechanical characteristics, not diagnostic or interpretive tasks where human readers' performance with/without AI assistance would be relevant.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's mechanical performance was evaluated independently against the ASTM F1798 standard. This was an "algorithm only" (or rather, "device only") performance evaluation, without human interpretation in the loop.

7. Type of Ground Truth Used

The ground truth used was compliance with the mechanical testing standard ASTM F1798. This standard sets specific methodologies and acceptance criteria for evaluating the mechanical properties of pedicle screw systems.

8. Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (pedicle screw system), not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no training set for a physical medical device.

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