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When used with the bone screws, the SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

When used with the SpinPlate™, the Vu aªPOD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate™, the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate™, is a stand-alone device. If the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is used only with the SpinPlate™ then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine® Vu a•POD™ Prime NanoMetalene® is an anterior intervertebral body fusion device (IBD) which can be used in combination with two titanium Bone Screws, a titanium SpinPlate™, or both Bone Screws and SpinPlate™ together. When used with Bone Screws or Bone Screws and SpinPlate™, the system is a stand-alone device. When used with the SpinPlate™ alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).

The Vu a•POD™ Prime NanoMetalene® IBD spacers are comprised of PEEK-OPTIMA® LT1 polymer and include large central graft windows, which are packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers have a one-micrometer thick layer of commercially pure (CP) titanium. NanoMetalene® (NM), that is molecularly bonded to the surface. Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation. The spacer will be provided in sterile packaging; the Bone Screws and SpinPlate™ will be provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with the Vu a•POD™ Prime NanoMetalene® IBD system facilitate the placement, adjustment, and final locking of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any clinical study details for a device that detects or diagnoses a condition using AI.

The document is a 510(k) premarket notification for an orthopedic intervertebral body fusion device (SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device). It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing (mechanical safety, sterilization, etc.), rather than an AI-powered diagnostic device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, or AI performance metrics.

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