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The Republic Spine Dark Deformity Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization 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
• Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• . Failed previous fusion

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Dark Star Deformity Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Dark Star Deformity Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/ or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Republic Spine Dark Star Deformity Pedicle Screw System (previously cleared as Dark Star Spinal System) is a multi-component posterior spinal fixation system which consists of pedicle screws, set screws, rods, hooks, connectors, and crosslinks. The system contains non-sterile single use components manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Deformity Pedicle Screw System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.

The scope of the Republic Spine Dark Star Deformity Pedicle Screw System is being extended with this submission via a line extension to offer new implant options including connectors, prebent rods, crosslinks, and hooks and to offer implant design modifications to the uniplanar screws, to the connectors, and to the hooks. New instrumentation will also be introduced to aid in the implantation of the new and existing implants. The indications for use are being expanded to include pediatric applications.

This document does not describe an AI/ML medical device, therefore the requested information for AI/ML performance acceptance criteria and study data is not available. This document is a 510(k) premarket notification for a medical device called the "Dark Star Deformity Pedicle Screw System," which is a spinal implant system.

Instead, the document focuses on the mechanical performance (verification testing) of the spinal implant system to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the performance data presented, related to the physical device:

1. Acceptance Criteria and Reported Device Performance (Implied from the study):

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. However, the performance data section indicates that the device was subjected to specific ASTM standards, and the conclusion states that the device is "substantially equivalent" to the predicate device based on this data. This implies that the device's performance results met the thresholds or comparable performance to the predicate device as defined by these ASTM standards.

2. Sample Size and Data Provenance for Test Set:

• This is not applicable as the study involves mechanical testing of physical device components, not a "test set" of clinical data for an AI/ML model. The "samples" would be the physical implants tested under laboratory conditions. The document does not specify the number of implants used for each test.
• Data Provenance: The tests are conducted in a laboratory setting, not with human patient data or from a specific country of origin in the context of clinical data.

3. Number of Experts and Qualifications for Ground Truth:

• This is not applicable to a mechanical testing study of a physical device. Ground truth, in the AI/ML context, refers to a verified label or outcome for a data point, typically established by human experts.

4. Adjudication Method:

• Not applicable for mechanical testing.

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

• Not applicable. This is a study on the mechanical properties of a physical medical device, not on the performance of human readers with or without AI assistance.

6. Standalone Performance Study:

• The "performance data" section (ASTM tests) can be considered a standalone performance study for the mechanical properties of the device components. It assesses the device's ability to withstand various forces and stresses independently. However, this is for the physical device, not an algorithm.

7. Type of Ground Truth Used:

• For mechanical testing, the "ground truth" is implicitly the physical properties and behavior of the materials and design under controlled laboratory conditions, as measured against established scientific and engineering standards (ASTM). The "truth" is the physical reality of how the device performs under specific loads, rather than a clinical label or outcome.

8. Sample Size for Training Set:

• Not applicable as this is not an AI/ML device.

9. How Ground Truth for Training Set was Established:

• Not applicable as this is not an AI/ML device.

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