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The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system 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 Tyche® Pedicle Screw System is 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 Tyche Pedicle Screw System is made up of muti-axial and standard screws, rods, locking cap, adjustable cross connectors. This system's intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. All components are made from medical grade titanium alloy (Ti-6Al-4V-ELI) by such as ASTM F136. The products are supplied clean and "NON STERILE".

The medical device in question is the Tyche® Pedicle Screw System. The provided text focuses on its 510(k) submission for substantial equivalence, primarily detailing its design, materials, indications for use, and a comparison to predicate devices, rather than an acceptance criteria and study proving performance in the traditional sense of a clinical or software-based diagnostic device.

Therefore, the information for some requested sections, particularly those related to clinical performance, ground truth, and expert evaluation, is not available in the provided document. The performance data discussed is exclusively bench testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a spinal implant, the "acceptance criteria" are typically defined by recognized standards for mechanical performance, and "device performance" refers to the results of testing against these standards.

*Note: The document states that testing was "performed in accordance with" ASTM F 1717-04, implying that the device met the requirements of this standard, which defines the acceptance criteria for mechanical performance of such implants. However, the specific quantitative results (e.g., actual load values, cycles survived) are not explicitly detailed in this summary; they are likely in the "mechanical testing report" mentioned in Appendix IV, which is not provided here.

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

• Sample size for test set: Not explicitly stated regarding the number of devices or constructs tested. The testing was conducted on "the worst case Tyche" pedicle screw system structure."
• Data provenance: Not applicable in the context of clinical data. This refers to bench testing performed on manufactured devices.

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

Not applicable. Ground truth for mechanical bench testing is established by the test setup and instrumentation measuring physical properties according to the ASTM standard. This does not involve expert clinical assessment or image interpretation.

4. Adjudication method for the test set

Not applicable. This concept (e.g., 2+1, 3+1) is relevant for studies involving human interpretation or clinical endpoints, not for mechanical bench testing.

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 mechanical implant, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

The ground truth for the "performance data" (bench testing) is based on mechanical properties and failure analysis as defined by the ASTM F 1717-04 standard. This standard simulates in-vivo conditions for spinal implants and assesses their structural integrity and strength.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

In summary, the provided 510(k) summary for the Tyche® Pedicle Screw System details its design, materials, indications, and substantial equivalence to predicate devices based on mechanical bench testing against an ASTM standard. It does not include information pertaining to clinical studies, human performance, or AI-related assessments.

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