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When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Cambria NanoMetalene® Surface technology is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.

The SeaSpine Vu aPOD-L NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu a POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

When used as an intervertebral body fusion device, the SeaSpine Vu e•POD System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e · POD System is intended for use with supplemental fixation. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

When used as a vertebral body replacement (VBR), the SeaSpine Vu e-POD System is indicated for use in the thoracolumbar spine (TI-LS) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu e-POD System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e•POD System is intended for use with supplemental internal spinal fixation.

Interbody Device (IBD) Implants (i.e., interbody implants used alone): The SeaSpine Regatta Lateral System with NanoMetalene surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with 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 composed of cancellous, cortical, 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 Regatta Lateral System is intended for use with supplemental fixation.

TruProfile Interbody Implants: The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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 Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology 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 composed of cancellous, cortical, and/or corticocancellous bone.

When used with the SpinPlate, 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. 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 composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene IntervertebralBody Fusion Device is intended for use with supplemental fixation.

The SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine 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 composed of cancellous, cortical, 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 Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of nonoperative treatment.

When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).

The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).

When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Interbody Device (IBD) Implants (i.e., interbody implants used alone): The SeaSpine Meridian System with NanoMetalene® surface technology interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

No-Profile Implants w/ Screws: The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors: The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile LockingCover, 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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 Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants: The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

The SeaSpine NanoMetalene Systems are single-use intervertebral fusion devices made from polyetheretherketone (PEEK per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. The devices are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy and are provided sterile-packed.

The provided text is a 510(k) Premarket Notification from the FDA, declaring "substantial equivalence" for various SeaSpine intervertebral body fusion devices. This document focuses on demonstrating that the new devices are as safe and effective as previously cleared predicate devices, primarily through comparison of design, materials, and existing performance standards.

Crucially, this document does not describe a clinical study (like an MRMC or standalone study) to prove specific device performance against acceptance criteria for an AI/imaging device. It's about a spinal implant system, not an AI-powered diagnostic or therapeutic device. Therefore, the requested information about acceptance criteria, test set characteristics, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-based device is not present in this document.

The "Non-Clinical Testing" section mentions demonstrating equivalent mechanical performance to predicate systems in accordance with ASTM standards (F1978, F1147, F1160, F1044), and equivalent biocompatibility and sterility. These are engineering design and material testing standards, not clinical performance metrics for an AI algorithm.

In summary, this document is entirely about a medical device (spinal intervertebral body fusion devices), not an AI/imaging device. As such, the information required to answer your specific questions about AI acceptance criteria and study details is not available within the provided text.

Ask a specific question about this device

When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Vu aºPOD-L NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

When used as an intervertebral body fusion device, the SeaSpine Vu e•POD System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e•POD System is intended for use with supplemental fixation. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

When used as a vertebral body replacement (VBR), the SeaSpine Vu e•POD System is indicated for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu e•POD System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e POD System is intended for use with supplemental internal spinal fixation.

When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology 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 composed of cancellous, cortical, and/or corticocancellous bone.

When used with the SpinPlate, 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. 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 composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The SeaSpine Vu aºPOD Prime NanoMetalene Intervertebral Body Fusion Device, when used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine Vu aºPOD 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 hyperlordotc 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 composed of cancellous, cortical, 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 Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.

When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).

The SeaSpine Cambria System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.

The SeaSpine Cambria NanoMetalene System with NanoMetalene® surface technology is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Regatta Lateral System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with 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 composed of cancellous, cortical, 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 Regatta Lateral System is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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 Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and havehad at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).

When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthess or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should havehad six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the in volved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Meridian System with NanoMetalene® surface technology interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio graphic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

No-Profile Implants w/ Screws:

The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors:

The SeaSpine Meridian System No-Profile Interbody, whenused with Inline Fixation Anchors and a No Profile Locking Cover, 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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 Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

The SeaSpine spacer systems featuring NanoMetalene® surface technology are single-use intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) or Ti-6Al-4V ELI (per ASTM F136) markers for radiographic visualization, and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The devices have a central canal for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this submission is to describe NanoMetalene surface technology as providing a microscopic roughened surface with nano-scale features and to revise the indications for use with reference to the surface technology.

The provided document is a 510(k) Premarket Notification from the FDA for a range of SeaSpine intervertebral body fusion devices. It is a regulatory clearance document, not a study report. Therefore, it does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or details about training sets. These types of data are typically found in clinical trial reports or validation studies, which are not part of this 510(k) summary.

The document's purpose is to establish "substantial equivalence" of the new device to existing legally marketed predicate devices, not to prove performance through a new clinical or non-clinical study for the current submission.

Specifically, the document states:

• "Non-Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of nonclinical performance data."
• "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information based on this document.

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Penumbra Coil 400:

• Intracranial aneurysms.
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
• Arterial and venous embolizations in the peripheral vasculature.

Ruby Coil System:

• Arterial and venous embolizations in the peripheral vasculature.

POD System (For POD Coils with nominal sizes ≤ 6 mm):

• Intracranial aneurysms.
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
• Arterial and venous embolizations in the peripheral vasculature.

POD System (For POD Coils with nominal sizes > 6 mm):

• Arterial and venous embolizations in the peripheral vasculature.

The subject devices (Penumbra Coil System and POD System) are designed for embolization in the neuro and/or peripheral vasculature. This is achieved by using coils to exclude the intended treatment area from blood flow, thus creating stasis and allowing thrombosis to occur. The subject devices consist of a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. The devices should only be used by physicians who have received appropriate training in interventional techniques.

The subject devices consist of the following components:

• Coil: The Coil is attached to a Delivery Pusher both contained within an Introducer Sheath. The Coil is an implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur.
• Delivery Pusher: The Delivery Pusher is composed of a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT) and a pull wire. The Delivery Pusher may also be referred to as the Detachment Pusher.
• Introducer Sheath: The Introducer Sheath is intended to cover the entire length of the Coil and the distal flexible segment of the Delivery Pusher. The Introducer Sheath is secured onto the Delivery Pusher with a friction lock to prevent unsheathing until use.
• Detachment Handle: The Detachment Handle is packaged separately. It is intended for use in multiple coil detachments performed during a single procedure.

This document, a 510(k) Premarket Notification for the Penumbra Coil System and POD System, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance, especially concerning Artificial Intelligence (AI) or software-based diagnostics.

Therefore, many of the requested details about acceptance criteria, clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), and training set information are not applicable to this type of submission. This document describes a medical device (embolization coils) that is a physical product, not an AI/software device.

Here's an attempt to extract relevant information and note where the requested information is not present:

Device: Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System); POD System
Device Type: Neurovascular Embolization Device

Acceptance Criteria and Reported Device Performance (Non-AI/Software Context)

For this physical device, "acceptance criteria" are typically defined by engineering specifications and performance benchmarks, proven through bench-top (laboratory) and biocompatibility testing. The "performance" is the passing of these tests, demonstrating that the device functions as intended and is safe.

Here's a table based on the provided "Bench-Top Testing" and "Biocompatibility Testing" sections:

Information Not Applicable or Not Provided for This Type of Submission (AI/Software-Specific Questions)

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • N/A. This is a physical device, and the "test set" here refers to the number of units or biological samples used in bench-top and biocompatibility testing, not a clinical data set for an AI model. The document does not specify the number of units tested for each bench-top criterion. Biocompatibility tests followed ISO and CFR guidelines.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • N/A. Ground truth establishment by experts is relevant for AI/diagnostic software. For a physical device, ground truth is established by objective measurements against engineering specifications and biological material reactions.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. Adjudication is for resolving discrepancies in expert interpretations, not for physical device testing.

4. 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:

   • N/A. This applies to AI-assisted diagnostic tools, not physical embolization coils.

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

   • N/A. This applies to AI/software.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For this device, "ground truth" related to performance is based on engineering specifications, direct physical measurements, and well-established biological response criteria (e.g., cell viability, immune response markers) in a laboratory setting, as well as adherence to recognized standards like ASTM and ISO. There is no "expert consensus" on ground truth for the physical and biological properties being tested here in the way there would be for a diagnostic image.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • N/A. There is no "training set" or AI model.

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The POD System is indicated for the embolization of:
Intracranial aneurysms
Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Arterial and venous embolizations in the peripheral vasculature

The POD System functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion in an equivalent fashion to existing bare-platinum embolization coils. The POD System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.

The provided text describes the acceptance criteria and study results for the Penumbra POD™ System, a neurovascular embolization device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Bench-top Testing: The document states that testing was performed "using units which were 2x sterilized and met finished goods release requirements." It also mentions "statistical sampling methods as required by the Penumbra Design Control procedures." However, specific sample sizes for each bench-top test are not provided.
• Biocompatibility Testing: The document states "Studies, were selected in accordance with EN ISO 10993 -1 guidelines" and "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices." Specific sample sizes for each biological test are not provided. For the "Implantation GLP Study - Penumbra Coil System in Swine Venous Pouch Aneurysm Model" and "Intramuscular Implant Test 13 Week Duration," it mentions "Swine" and "13 Week Duration," implying animal models, but no specific animal count is given.
• Data Provenance: The studies are described as "Non-clinical testing" and conducted under "Good Laboratory Practices (GLP)," indicating they are laboratory-based studies rather than human clinical data. The "Implantation GLP Study" mentions a "Swine Venous Pouch Aneurysm Model," indicating animal data. The document does not specify the country of origin for the data, but Penumbra, Inc. is located in Alameda, CA, USA. The studies are prospective in nature as they are conducted for device verification and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable to this device submission. This submission focuses on engineering, biocompatibility, and animal (GLP) testing for substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC comparative effectiveness study was not performed as this is a device submission for an embolization system, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation. The focus is on the device's physical, mechanical, and biological properties, and its substantial equivalence to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

• Not applicable. The POD System is a medical device (coil implant, detachment pusher, handle) for physical embolization, not a software algorithm.

7. The Type of Ground Truth Used:

• Bench-top Testing: Engineering specifications and objective measurements (e.g., dimensional measurements, force measurements for friction/tensile tests, visual inspection criteria, retention of shape).
• Biocompatibility Testing: Established international standards and guidelines (EN ISO 10993) and Good Laboratory Practices (GLP) for biological responses.
• Design Validation (GLP Animal Testing): Biological responses in animal models, evaluated against expected physiological interactions and safety profiles.

8. The Sample Size for the Training Set:

• Not applicable. This submission describes a medical device, not an AI/ML algorithm that requires a training set. The "training set" concept does not apply here.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

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