(86 days)
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.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device addresses the same conditions and patient population as predicates. | "The NuVasive® Thoracolumbar Interbody Systems are indicated for intervertebral body fusion of the spine in skeletally mature patients... for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation... can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity." (Multiple specific indications for each system, mirroring predicate uses). |
| Technological Characteristics Equivalence: Materials, design, and function are substantially similar to predicates, or differences don't raise new safety/effectiveness concerns. | "The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes." |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.