Search Results

The NuVasive® Thoracolumbar Interbody Systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1), and the CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive CoRoent XL Interfixated System implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of nonoperative treatment.

The NuVasive CoRoent XL Interfixated System implants are intended for use in interbody fusions in the lumbar spine, from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive CoRoent XL Interfixated System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System platform implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the Brigade System platform must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The Brigade Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade Lateral System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The BASE Interfixated Titanium System is indicated for spinal fusion procedures in skeletally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The BASE Interfixated Titanium System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The BASE Interfixated System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the BASE Interfixated Titanium System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The NuVasive Coalesce Thoracolumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Coalesce Thoracolumbar Interbody Fusion System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Coalesce Thoracolumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the Cohere XLIF internal fixation, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1), and in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without Modulus XLIF internal fixation, the system is intended for use with supplemental spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus XLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus TLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of nonoperative treatment.

The NuVasive Modulus TLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus TLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The Modulus ALIF System 10°-20° lordotic cages may be used as a standalone system. The Modulus ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Modulus ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The NuVasive Thoracolumbar Interbody Systems are intervertebral body fusion devices, interfixated and non-interfixated. Implants are manufactured of either PEEK-Optima® LT-1 (Polyether-ether-ketone) conforming to ASTM F2026 or Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136/ISO 5832-3. PEEK implants include radiographic markers made of Titanium (Ti) conforming to ASTM F136/ISO 5832-3 or ASTM F1472, or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. Interfixated implants include Titanium alloy (Ti6A14V ELI) screws conforming to ASTM F136/ISO 5832-3, and in addition, CoRoent Thoracolumbar Interfixated implants include canted coil locking mechanism of Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562.

CoRoent Thoracolumbar System: The subject NuVasive CoRoent Thoracolumbar System are interbodies manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6A1-4V) conforming to ASTM F136. The PEEK devices contain titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472 or tantalum markers conforming to ASTM 560 or ISO 13782. The device's hollow core or graft aperture allows for packing of autograft to help promote a solid fusion. Small spikes or teeth on each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

CoRoent XL Interfixated System and Brigade Hyperlordotic System: The subject CoRoent Thoracolumbar System (Interfixated) and Brigade Hyperlordotic System are interbodies manufactured from PEEK-Optima LT-1 conforming to ASTM F2026 PEEK-Optima® LT-1, with radiographic markers manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and CoRoent Thoracolumbar Interfixated implants include canted coil locking mechanism of Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. The devices all contain integrated screws made of titanium alloy, and include a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. The subject implants contain small spikes or teeth on each end of the device, which serve to grip the adjacent vertebrae to resist migration and expulsion. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the CoRoent XL-F System and Brigade Hyperlordotic System devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Coalesce Thoracolumbar Interbody Fusion System: The NuVasive Coalesce Thoracoumbar Interbody Fusion System comprises of sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the thoracolumbar spinal column in thoracolumbar intervertebral body fusion procedures. Each device within the Coalesce System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under xray in vivo.

Cohere Thoracolumbar Interbody Fusion System: The NuVasive Cohere Thoracolumbar Interbody System comprises of sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the thoracolumbar spinal column in thoracolumbar intervertebral body fusion procedures. Each device within the Cohere Thoracolumbar Interbody System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more radiolucent markers, depending on footprint, to enable visibility under x-ray in vivo.

Brigade Standalone System: The NuVasive Brigade Hyperlordotic System is an interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Hyperlordotic System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Hyperlordotic intervertebral fusion device is a device composed of a PEEK interbody implant containing radiographic titanium alloy markers, and-four (4) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK OPTIMA LTI) conforming to ASTM F-2026 and titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and 150 5832-3.

Brigade Lateral System: The NuVasive® Brigade® Lateral System is an interfixated interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Lateral System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Lateral System intervertebral fusion device is composed of a PEEK interbody implant containing radiographic titanium alloy markers, and two (2) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMAL LT1) conforming to ASTM F2026 and titanium alloy (Ti-6A-4V ELI) conforming to ASTM F136 and ISO 5832-3 or (Ti-6A-4V) conforming to ASTM F1472.

Base Interfixated Titanium System: The NuVasive BASE Interfixated Titanium System is an interfixated interbody system manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive BASE Interfixated Titanium System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The BASE Interfixated Titanium System consists of a titanium alloy interbody and three (3) titanium alloy bone screws. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

Modulus XLIF: The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Modulus TLIF: The subject NuVasive Modulus TLIF Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Modulus ALIF System: The subject NuVasive Modulus ALIF System, previously cleared as 3DP Interfixated System, are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Modulus ALIF System 10°-20° lordotic cages may be used as a standalone system. The Modulus ALIF System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The provided document pertains to a 510(k) premarket notification for a medical device (NuVasive Thoracolumbar Interbody Systems) and as such, it does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The document describes various intervertebral body fusion devices, their indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. It explicitly states in Section G, "Performance Data": "No new NuVasive Thoracolumbar Interbody Systems implant designs are being introduced... Nevertheless, minor design modifications were made to certain devices... We include the confirmatory mechanical testing that shows that the minor design modifications do not create a new worst case that would require new or additional testing. Since spinal stenosis use does not change the biomechanical stresses placed upon the individual implants, additional non-clinical testing is unwarranted. Therefore, no performance testing was performed for this 510(k) submission and the worst case devices included with the subject system were tested and cleared in predicate 510(k) submissions. Only previously cleared devices are the subject of this submission, i.e., there is no new worst case device."

It also states in Section F, "Technological Characteristics": "This device does not contain software or electrical equipment."

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML performance studies is not applicable to this document. This submission focuses on demonstrating substantial equivalence for an existing class of physical implants based on mechanical testing and a clinical literature analysis, not on the performance of a novel AI/ML algorithm.

Ask a specific question about this device

The NuVasive CoRoent Thoracolumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Nu Vasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1), and the CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive CoRoent XL Interfixated System implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive CoRoent XL Interfixated System implants are interbody fusions in the lumbar spine, from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Nu Vasive CoRoent XL Interfixated System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlorio System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogeneic bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System platform implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the Brigade System platform must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The Brigade Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The Brigade Lateral System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade Lateral System implants can adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The BASE Interfixated Titanium System is indicated for spinal fusion procedures in skeletally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The BASE Interfixated Titanium System is interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The BASE Interfixated System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the BASE Interfixated Titanium System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The Coalesce Thoracolumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of nonoperative treatment.

The Coalesce Thoracolumbar Interbody Fusion System is interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Coalesce Thoracolumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Cohere Thoracolumbar Interbody System is interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1), and in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without Modulus XLIF internal fixation, the system is intended for use with supplemental spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus XLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus TLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of nonoperative treatment.

The NuVasive Modulus TLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus TLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Nu Vasive 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The 3DP Interfixated ALIF System used with less than 3 bolts must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Nu Vasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 3DP Interfixated ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the 3DP Interfixated ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The NuVasive Thoracolumbar Interbody Systems are intervertebral body fusion devices, interfixated and non-interfixated. Implants are manufactured of either PEEK-Optima® LT-1 (Polyether-ether-ketone) conforming to ASTM F2026 or Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136/ISO 5832-3. PEEK implants include radiographic markers made of Titanium (Ti) conforming to ASTM F136/ISO 5832-3 or ASTM F1472, or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. Interfixated implants include Titanium alloy (Ti6Al4V ELI) screws conforming to ASTM F136/ISO 5832-3, and in addition, CoRoent Thoracolumbar Interfixated implants include canted coil locking mechanism of Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562.

The provided text describes a 510(k) premarket notification for various intervertebral body fusion devices. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not typically part of a 510(k) summary for these types of Class II spinal implants.

However, I can extract and infer some information based on the document's content.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table of explicit acceptance criteria or quantitative performance metrics in the way one would see for an AI/CADe device or a new technology requiring de novo clearance. For spinal implants cleared via 510(k), "acceptance criteria" are generally tied to demonstrating substantial equivalence in terms of:

• Intended Use: The device performs the same function for the same condition.
• Technological Characteristics: The materials, design, and operating principles are similar or equivalent, and any differences do not raise new questions of safety or effectiveness.
• Performance: The device performs as safely and effectively as the predicate, often demonstrated through non-clinical (e.g., mechanical, biocompatibility) testing.

The "performance" reported here is a qualitative assessment of substantial equivalence.

Implants are manufactured from PEEK-Optima® LT-1 or Titanium alloy (Ti6Al4V ELI). Interfixated implants include Titanium alloy screws. (Similar to predicate materials). |
| Safety and Effectiveness Equivalence: Demonstrated through established clinical use and/or non-clinical testing. | "Based on the clinical data, it was determined that the NuVasive Thoracolumbar Interbody Systems used in the treatment of thoracolumbar sagittal deformities has a safety and effectiveness profile similar to the predicate device."

"No new NuVasive Thoracolumbar Interbody Systems implant designs are being introduced... minor design modifications were made... We include the confirmatory mechanical testing that shows that the minor design modifications do not create a new worst case that would require new or additional testing."

"Therefore, no performance testing was performed for this 510(k) submission and the worst case devices included with the subject system were tested and cleared in predicate 510(k) submissions." |

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. This submission primarily relies on demonstrating equivalence to existing cleared devices, particularly for a broadened indication (multilevel degenerative scoliosis and sagittal deformity). The document states, "A clinical literature analysis of thoracolumbar sagittal deformities treated with the subject device was performed." This refers to a literature review, not a new clinical study with a prospectively defined test set of patients for device performance evaluation.
• Data Provenance: The nature of the "clinical literature analysis" means the data provenance would be from published studies, which could originate from various countries and be retrospective or prospective depending on the individual studies included in the analysis. The document does not specify.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. As no new clinical study was conducted with a defined "test set" requiring ground truth establishment by experts for specific outcomes, this information is not provided. The determination of "substantial equivalence" is made by the FDA based on the provided technical and comparative information and literature review.

4. Adjudication method for the test set:

• Not applicable. There was no specific test set requiring adjudication in the context of this 510(k) submission.

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 submission for spinal implants, not an AI or imaging diagnostic device.

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

• Not applicable. This is a physical implant device, not an algorithm.

7. The type of ground truth used:

• For this 510(k) submission, the "ground truth" for the new indication (multilevel degenerative scoliosis and sagittal deformity) is established through clinical literature analysis. This means the safety and effectiveness profile of using these types of devices for this condition, as reported in existing peer-reviewed literature, serves as the basis for enabling expanded indications. The FDA relies on the predicate devices' established safety and effectiveness and the literature supporting the similar safety and effectiveness for the expanded use.

8. The sample size for the training set:

• Not applicable. No "training set" in the machine learning sense was used, as this is a physical medical device. The "training" for the device's design and use comes from existing medical knowledge, biomechanical principles, and the history of predicate devices.

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

• Not applicable. As above, no machine learning training set was used. The basis for the device's design and function comes from established clinical practice, biomechanical data from prior predicate devices, and manufacturing standards for medical implants.

Ask a specific question about this device

The Brigade Hyperlordotic System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Brigade Hyperlordotic System is intended for use with autograft. The Brigade Hyperlordotic System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

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

The NuVasive Brigade Hyperlordotic System is an interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Hyperlordotic System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Hyperlordotic intervertebral fusion device is a device composed of a PEEK interbody implant containing radiographic titanium alloy markers, and four (4) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMA LT1) conforming to ASTM F-2026 and titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.

The NuVasive® Brigade® Hyperlordotic System is an intervertebral body fusion device. The provided text describes the nonclinical testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study establishing performance against specific acceptance criteria for a new clinical endpoint.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document details nonclinical (preclinical) testing, not a clinical study with a "test set" of patients. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided. The tests mentioned are laboratory-based mechanical and material assessments.

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

This information is not applicable. The "ground truth" for the nonclinical tests is based on established engineering standards (e.g., ASTM standards) and the performance of the predicate device for comparison. There is no mention of expert adjudication for these engineering tests.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as this was a nonclinical study based on standardized tests.

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

No MRMC study was performed or mentioned. This device is a physical intervertebral body fusion device, not an AI-based diagnostic or assistive software.

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

Not applicable. This device is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests was based on established engineering standards (ASTM and ISO) and the performance metrics of the legally marketed predicate devices. The goal was to demonstrate that the subject device's performance meets or exceeds these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the testing described is nonclinical. There is no "training set" in the context of machine learning or AI algorithms.

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

Not applicable. No training set was used.

Ask a specific question about this device