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The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization of the spinal segments, (T1 - S2/ilium) or as an anterolateral fixation system (T8 - L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (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; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor, pseudarthosis; and failed previous fusion.

The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation.

The SEURAT™ Universal Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, hooks, connectors, and a transverse (cross) linking mechanism. Various sizes of these implants are available. SEURAT™ Universal Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

SEURAT™ Universal Pedicle Screw System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. The rods, screws utilized as part of the proposed system are identical to devices cleared previously via K120714, K132365, and K140219. The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously via K120714, K121568, K132365, and K140219.

The fundamental scientific technology and intended use are unchanged from the legally marketed predicate pedicle screw systems. The proposed system will use a modified version of DALI Spinal Fixation System previously cleared via K121568, a modified version of RAPHAEL Pedicle Screw System previously cleared via K132365 and additional lengths for anatomically bigger patients, and a modified version of PICASSO-II MIS Spinal System previously cleared via K140219 predicate based on the K120714, PICASSO MIS Spinal System) and additional size and lengths for anatomically bigger patients. The modifications include additional hexalobe screw-head driver feature; screw thread profiles, sizes, and lengths; and/or Minimally Invasive Spine (MIS) screw housing tower ring enhancement which will accommodate wider range of surgeons' usage preference, anatomically bigger patients, and/or consolidation of similar sub-components throughout all CTL Medical's pedicle screw systems for manufacturing efficiency.

The provided document describes a medical device, the SEURAT™ Universal Pedicle Screw System, and the testing conducted to support its substantial equivalence to predicate devices. It is a 510(k) summary, which focuses on demonstrating equivalence rather than establishing novel claims of safety and effectiveness through extensive clinical trials.

Therefore, the information you've requested regarding AI algorithm performance, sample sizes for training/test sets in that context, expert adjudication, AI improvement effect size, and specific ground truth definitions for an AI system are not applicable to this document. The study described is a mechanical performance safety study, not a study of an AI device.

Here's the information relevant to the mechanical performance study, extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text, but it would have been a number of device units tested according to the ASTM F1717 standard.
• Data Provenance: Not applicable as this is a mechanical testing study, not a study involving human or patient data. The testing was performed according to an industry standard (ASTM F1717).

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

• Not applicable. The "ground truth" here is the physical performance of the device against a mechanical standard, not a clinical observation by experts. The standard (ASTM F1717) defines the testing methodology and performance benchmarks.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are relevant for clinical studies where multiple reviewers assess data. In mechanical testing, results are quantitative measurements interpreted against pre-defined acceptance criteria.

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 a study involving human readers or AI.

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

• Not applicable. This device is a pedicle screw system, not an algorithm or AI.

7. The type of ground truth used:

• The "ground truth" for this study is defined by the acceptance criteria established by the ASTM F1717 standard. This standard specifies how pedicle screw systems should be mechanically tested and what performance metrics they must achieve to be considered safe and effective in terms of mechanical stability and durability.

8. The sample size for the training set:

• Not applicable. No training set is involved as this is mechanical testing of a medical device, not an AI or machine learning study.

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

• Not applicable. See point 8.

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