Search Results

The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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:
• 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; and
• Failed previous fusion.

The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system contains non-sterile single use 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 Spinal 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 Start Spinal System is being extended via a line extension to include additional rods, connectors, hooks and screws. New instrumentation will also be introduced to aid in the implantation of the new implants.

The safety and effectiveness of the fenestrated screw have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The fenestrated screws are intended to be used with saline or radiopaque dye.

This is a medical device submission for the Republic Spine Dark Star Spinal System, which is a multi-component posterior spinal fixation system. As such, the acceptance criteria and performance data are based on non-clinical (mechanical) testing rather than clinical performance (like an AI/CAD system would require).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The subject Republic Dark Star Spinal System implants were subjected to the following verification testing per required standards to establish substantial equivalent performance to the predicate device." It does not provide specific numerical results or pass/fail thresholds for these tests, rather it indicates that the tests were performed and the device demonstrated "substantial equivalent performance."

2. Sample size used for the test set and the data provenance

For the non-clinical performance data, the "sample size" refers to the number of devices or components tested for each mechanical test. The document does not explicitly state the exact number of samples tested for each ASTM standard.

• Data Provenance: The tests are described as "verification testing" performed on the "subject Republic Dark Star Spinal System implants." This implies in-house laboratory testing conducted by the manufacturer to demonstrate substantial equivalence to the predicate device. There is no information regarding the country of origin of the data as these are mechanical tests.

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

This question is not applicable to this type of medical device submission. Ground truth established by experts is typically relevant for diagnostic or clinical evaluation of devices (e.g., AI/CAD systems interpreting images). For mechanical spinal implants, the "ground truth" is defined by the performance requirements of established ASTM standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical evaluations or image interpretations where multiple experts assess the same cases. Mechanical testing follows standardized protocols, and results are typically objective measurements.

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

This question is not applicable. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. This submission is for a spinal implant.

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

This question is not applicable. "Standalone performance" refers to the evaluation of an AI algorithm without human involvement. This submission is for a physical medical implant, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" is based on engineering standards and design specifications. The device's performance is compared against the established mechanical properties and performance characteristics required by the referenced ASTM standards (ASTM F1717 and ASTM F1798) and its predicate device.

8. The sample size for the training set

This question is not applicable. "Training set" is a concept used in machine learning for AI algorithms. For a mechanical implant, there is no "training set" in this context. The manufacturing process and design are based on engineering principles and material science, not statistical training data.

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

This question is not applicable for the reasons mentioned in point 8. The "ground truth" for the design and manufacturing of the device is established by adherence to recognized engineering standards, material specifications, and quality control processes.

Ask a specific question about this device