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The DeGen Medical E3 MIS Pedicle Screw System is intended to provide immobilization 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; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the DeGen Medical E3 MIS Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The DeGen Medical E3 MIS Pedicle Screw System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

DeGen Medical E3 MIS Pedicle Screw System composed of cannulated and non-cannulated pedicle screws of various lengths and diameters which are designed to accept a 5.5mm rod in various lengths. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. Additionally, the DeGen Medical E3 MIS Pedicle Screw System may be used interchangeably with the DeGen Medical F1 MPS system including the CONNECT-L Transverse Connector and JOUST minimally invasive rods. This submission addresses both the the DeGen Medical E3 MIS Pedicle Screw System and minor design changes for manufacturability of the F1 MPS. The DeGen Medical E³ MIS Pedicle Screw System is provided non-sterile. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 and/or cobalt-chromium-molybdenum per ASTM F1537.

This document describes a 510(k) premarket notification for the DeGen Medical E3 MIS Pedicle Screw System. It is a submission for a medical device seeking substantial equivalence to legally marketed predicate devices, not an AI/ML powered medical device. Therefore, the information typically found in an AI/ML device submission regarding acceptance criteria, study methodologies, training/test sets, human expert involvement, and ground truth establishment is not present in this document.

The document discusses non-clinical performance testing for the mechanical properties of the pedicle screw system to demonstrate substantial equivalence to existing devices.

Key information provided in the document related to testing:

1. Acceptance Criteria and Reported Device Performance: This information would typically be detailed in the test reports themselves, demonstrating compliance with specific ASTM standards. The document states:

   • Acceptance Criteria/Standards: ASTM F1717 (Static and dynamic compression testing), ASTM F543 (Screw pullout strength), ASTM F1798 (Static tulip head disassembly, Dynamic flexion-extension testing).
   • Reported Device Performance: "The results of these studies show the subject DeGen Medical E³ MIS Pedicle Screw System meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent." (Page 5, "Non-Clinical Performance Testing Conclusion" table entry). Specific quantitative performance metrics are not provided in this summary.

2. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing of a pedicle screw system. The "test set" here refers to the physical devices undergoing mechanical stress tests, not a dataset of patient information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is defined by the physical properties and performance metrics specified in the ASTM standards. Testing is performed by qualified technicians and engineers in a lab setting, not by medical experts establishing a diagnostic ground truth from patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is relevant for clinical or diagnostic studies involving human review, not mechanical 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 is a mechanical device, not an AI/ML algorithm requiring human interpretation of output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is established by the specified mechanical performance requirements of the relevant ASTM standards (e.g., specific loads, displacements, and failure modes).

8. The sample size for the training set: Not applicable. There is no AI/ML training set for this device.

9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set for this device.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (pedicle screw system) through non-clinical mechanical performance testing against established ASTM standards, rather than evaluating an AI/ML algorithm's performance.

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