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The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are non-cervical, pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion 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.

In addition, the SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw System are 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis)

The SYNSTER® Pedicle Screw System and the SYNSTER® PLUS Pedicle Screw . System are posterior, noncervical, pedicle screw spinal system which consists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case. Please note that certain components are specifically designed to connect to ø 5.5mm or ø 6.0mm rods. Care should be taken so that the correct components are used in the spinal construct. The Pedicle Screw Spinal Fixation System was made out of medical grade titanium alloy described by standard such as ASTM F136. Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use any of the Pedicle Screw Spinal Fixation System with components from any other system or manufacturer unless specifically allowed to do so in this. The Pedicle Screw Spinal Fixation System implant will be provided non-sterile.

The provided text is a 510(k) Summary for a medical device called the SYNSTER® Pedicle Screw System and SYNSTER® PLUS Pedicle Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical or standalone study.

Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and even detailed training set information) are not applicable or not explicitly detailed in this type of regulatory submission.

Here's an breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. Instead, it demonstrates compliance with mechanical testing standards to prove the physical properties and safety of the pedicle screw system are substantially equivalent to existing, legally marketed devices.

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

• Sample size for test set: Not applicable/not stated. The non-clinical tests relate to the physical device components, not a "test set" of patient data.
• Data provenance: Not applicable/not stated, as this is a mechanical engineering study, not a clinical data study.

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

Not applicable. Ground truth, in the context of this 510(k), would refer to the validated mechanical properties and stress tolerances according to engineering standards (ASTM F1717). This is established by engineering principles and testing protocols, not human experts evaluating patient data.

4. Adjudication method for the test set:

Not applicable. There is no "test set" in the sense of a dataset requiring adjudication. Mechanical tests follow predefined procedures.

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 device is a pedicle screw system, a physical implant for spinal fixation, not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.

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

Not applicable. As noted, this is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for this submission is based on adherence to recognized mechanical engineering standards (ASTM F1717) for spinal implant devices and comparison to the performance of legally marketed predicate devices. The "truth" is that the device's mechanical properties meet the established benchmarks for safety and performance in its intended use.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for this type of device submission. The device is manufactured and tested based on established engineering designs and materials.

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

Not applicable. (No training set in the AI sense). The "ground truth" for the device's design and manufacturing is established through adherence to medical device design principles, material science, and performance specifications derived from relevant ASTM standards and predicate device characteristics.

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