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The Solar-STM (Standalone) and Solar-A™ (Non-Standalone) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-A™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

• Solar-STM Used With Screws or Tusks:
When used with three (3) screws, interbody devices with a lordotic angle ≤ 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.

When used with three (3) tusks, interbody devices must always be used with supplemental fixation and may be used at 1 or 2 levels.

Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.

• Solar-ATM:
These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Solar-MTM ALIF Spacers (Without Integrated Fixation)
Solar-M™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolilsthesis, deformity (degenerative scoliosis or kyphosis), and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have has at least six (6) months of non-operative treatment. Solar-M™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.

The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device for anterior lumbar fusion procedures. The Solar™ system includes various widths, depths, and heights. The Solar™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature a porous surface to mitigate subsidence and expulsion. The standalone (Solar-S™), anterolateral (Solar-A™), and monolithic (Solar-M™) configurations feature an anterior face with threaded holes and slots to rigidly connect to an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. The DeGen Medical Solar™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ and Solar-A™ incorporate integrated fixation in the form of screws manufactured from Titanium-6AL-4V ELI Alloy per ASTM F136 or tusks additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have

This document describes the DeGen Medical Solar™ Lumbar Interbody Fusion System and its 510(k) clearance (K240326). It does not contain information about an AI/ML device or its performance criteria.

Therefore, I cannot provide a response based on the requested information categories as they pertain to AI/ML device studies. The document describes a traditional medical device (an intervertebral body fusion device), and the "performance testing" mentioned refers to non-clinical mechanical testing, not software performance.

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The DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:

• · Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spinal Stenosis .
• Trauma (i.e. fracture or dislocation) .
• Deformity or curvatures (including scoliosis, kyphosis, or lordosis) .
• . Spinal Tumors
• Pseudoarthrosis or failed previous fusion .
• Spondylolisthesis .
• Decompression of the spinal following total or partial cervical vertebrectomy .

The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text is a 510(k) summary for a medical device, the DeGen Medical Cyclops™ Anterior Cervical Plate System. It describes the device's intended use, technological characteristics, and non-clinical performance testing. However, this document does not contain information about an AI/ML-based medical device. Therefore, it is not possible to describe acceptance criteria or a study proving an AI/ML device meets those criteria from this text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, function, and mechanical performance rather than clinical performance or AI algorithm assessment.

Therefore, I cannot fulfill the request as the core information regarding an AI/ML device's acceptance criteria, performance study details, ground truth establishment, or human-in-the-loop analysis is absent from the provided text.

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