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The F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondy|olisthesis (grades 3 and 4) of the L5-S1 vertebra; Fracture; Dislocation; Spinal stenosis; Scoliosis or kyphotic deformities; Spinal Tumor; Schuermann's disease; Failed previous fusion.

The F1 MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The F1 MPS is also intended to stabilize the posterior non-cervical fixation indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft.

The F1 MPS system is modular 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.

This submission addresses the line extension of CONNECT-L Transverse Connector and JOUST minimally invasive rods to the F1 MPS Modular Pedicle Screw System (K142531), and make FDA aware of minor changes to F1 MPS for manufacturability.

The CONNECT-L Transverse Connector comes in fixed and variable sizes. The JOUST™ minimally invasive rods are used in a minimally invasive approach. The JOUST™ minimally invasive manual surgical instruments aid in percutaneous approach. Additional 5.5mm rods are added to this system to allow for ease of entry.

The F1 MPS 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.

The provided document is a 510(k) summary for the DeGen Medical F1 MPS Modular Pedicle Screw System. It describes a medical device, specifically a spinal implant, and its mechanical testing to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI/ML powered medical device, nor does it present clinical study data with acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe acceptance criteria and associated study details for an AI/ML powered medical device based on this document. The document focuses on hardware (pedicle screw system), not software or AI performance.

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