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The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
• Spondylolisthesis
• Trauma (i.e. fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e. scoliosis, kyphosis)
• Spinal tumor
• Pseudoarthrosis, and/or
• Failed previous fusion

The X-spinesw Cortical Bone Screw System consists of pedicle screws, rods, cross connectors, and associated instruments. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system implant components are manufactured from Ti6Al4V ELI, a titanium based alloy which complies with ASTM F136. Alternatively, rods are also offered manufactured from cobalt chromium alloy which complies with ASTM F1537. The single use only implants are provided non-sterile, and should not be reused under any circumstances.

The system does not contain software/firmware or electrical equipment.

This document is a 510(k) premarket notification for a medical device called the "X-spine Cortical Bone Screw System." It seeks to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than establishing new acceptance criteria or proving effectiveness through a traditional clinical study.

Therefore, many of the requested points regarding acceptance criteria and performance studies are not directly applicable or available in this type of submission. This 510(k) summary focuses on equivalence to existing devices.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not present specific acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) for a diagnostic or therapeutic AI device. Instead, it describes mechanical testing to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" here are implied to be meeting or exceeding the mechanical performance of the predicate device.

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

This information is not provided. The testing described is mechanical, not clinical, and typically involves a specific number of devices or components. Details on the number of samples tested are not included. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical testing.

3. 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. This is a submission for a spinal implant, not an AI device or a diagnostic tool requiring expert ground truth for a test set. The "ground truth" for mechanical testing is established by standard laboratory procedures and measurements.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI device or a diagnostic tool that would involve human readers or an MRMC study.

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

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

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

For mechanical testing of devices like this, the "ground truth" is typically defined by standardized physical measurements and engineering specifications, often established by ASTM standards (e.g., ASTM F1717). There is no "expert consensus" or "pathology" in the context of mechanical performance.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for it.

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