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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 interbody fusions in the thoracic spine from T1 to T12, 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 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.

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.

The implants are available in a variety sizes and lordostic 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.

An optional single-sided or dual-sided internal fixation plate with bone screw(s) is offered; this is referred to as the AMS XLIF Plate Single-Sided and AMS XLIF Plate Dual-Sided, respectively. The AMS XLIF Plate is placed in the adjacent vertebral body or bodies for additional migration resistance. The AMS XLIF Plates are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient. The AMS XLIF Plate Single/Dual Sided and bone screws are substantially equivalent to the plate and screws cleared in predicate Modulus XLIF Interbody System (K192760).

This document describes NuVasive® Cohere® Thoracolumbar Interbody System, an intervertebral body fusion device. No information on acceptance criteria or results from studies proving the device meets those criteria is provided for AI/imaging device performance since this is a physical medical device, not an AI or imaging device. The document is an FDA 510(k) clearance letter and summary for a physical medical implant, specifically an intervertebral body fusion device made of PEEK.

Therefore, the requested information regarding acceptance criteria, study design for AI/imaging device performance (e.g., sample size for test sets, number of experts, MRMC studies, standalone performance), and ground truth establishment does not apply to this device.

The "Performance Data" section (Section G) explicitly states: "Non-clinical testing was performed to demonstrate that the subject Cohere Thoracolumbar Interbody System is substantially equivalent to other predicate devices. Engineering rationale and the following testing was performed: Static Axial Compression (per ASTM F2077), Dynamic Axial Compression (per ASTM F2077), Dynamic Torsion (per ASTM F2077), Compressive and Torsional Wear Particulate Analysis (per ASTM F1877), Implant subsidence and expulsion analysis, Screw push-out analysis. The results demonstrate that the subject Cohere Thoracolumbar Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted."

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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.

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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 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 Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12, 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 NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

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. 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.

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.

The provided document is an FDA 510(k) clearance letter for the NuVasive® Cohere® Thoracolumbar Interbody System. This document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it concerns a physical intervertebral body fusion device.

Therefore, most of the requested information regarding acceptance criteria, study design for a diagnostic device, sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable (N/A) to this document's content.

However, I can extract information related to the device's performance data and the basis for its clearance, which can be interpreted in the context of "acceptance criteria" for a physical medical device.

Here's what can be extracted from the provided text:

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

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

• Sample size: Not specified as N/A in the context of a physical device. Performance was assessed through non-clinical (mechanical) testing, not patient data.
• Data provenance: N/A. The testing was non-clinical engineering testing.

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

• Number of experts: N/A. Ground truth was established through engineering standards (ASTM) and comparison to predicate devices, not expert human evaluation of typical diagnostic outputs.
• Qualifications of experts: N/A.

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

• Adjudication method: N/A. This concept is for clinical or diagnostic studies. The evaluation here was based on specified engineering tests and comparison to a predicate device.

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:

• MRMC study: No. This is a physical device, not an AI/diagnostic software.
• Effect size: N/A.

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

• Standalone performance: N/A. This is a physical device, not an algorithm.

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

• Type of ground truth: The "ground truth" for this device's performance is adherence to established engineering standards (ASTM) and demonstration of substantial equivalence to already cleared predicate devices based on design, materials, and functional testing.

8. The sample size for the training set:

• Training set sample size: N/A. This device does not involve machine learning or a "training set."

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

• Ground truth establishment for training set: N/A.

In summary, the document describes the clearance of a physical medical device based on non-clinical engineering testing and substantial equivalence to predicate devices, rather than a diagnostic AI/ML system. Therefore, many of the questions are not applicable to the content provided.

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The NuVasive MLX - Medial Lateral Expandable Lumbar 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 used in patients who have had at least six months of non-operative treatment.

The NuVasive MLX- Medial Lateral Expandable Lumbar Interded for use in interded 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 degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy 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 MLX- Medial Lateral Expandable Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The NuVasive AP Expandable XLIF 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 (e.g., pedicle screw/rod 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 AP Expandable XLIF 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) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy 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 AP Expandable XLIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.

The NuVasive MLX and APX Interbody Devices are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This scope of this 510(k) includes expanded indications for use and minor add-to-file changes.

This document is a 510(k) Premarket Notification from the FDA regarding the NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System and the NuVasive AP Expandable XLIF System. It determines these devices are substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not provide explicit acceptance criteria or reported device performance metrics in the format of a typical performance study. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. This means that if the predicate devices meet performance requirements, and the new device is sufficiently similar, it can be marketed.

   The performance data mentioned pertains to mechanical testing and bacterial endotoxin testing.

   Acceptance Criteria Category/Type	Reported Device Performance/Testing
   Mechanical Performance	"Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. The previously presented mechanical testing data are sufficient to support the subject system and does not warrant the need for additional nonclinical testing." (Referencing K153105 and K140162 for specific data)
   Biocompatibility/Bacterial Endotoxin	"Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016." (No specific pass/fail values or results are explicitly stated in this summary, but the implication is that it passed the standard.)

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

   Since no new clinical or performance study was conducted for this specific 510(k) submission (K173025) beyond referencing prior submissions, there is no new test set sample size or data provenance provided in this document. The mechanical testing data relies on previous submissions (K153105 and K140162), and the bacterial endotoxin testing would typically be performed on a representative sample of manufactured devices.
   The document does not specify country of origin for any data cited from previous submissions, nor whether it was retrospective or prospective.

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

   Not applicable. No new clinical or comparative performance study with an expert-established ground truth was conducted for this submission. The ground truth for interbody fusion devices in a 510(k) context often relates to demonstrating material properties, mechanical integrity, and biocompatibility, rather than diagnostic accuracy that would require expert consensus on cases.

4. Adjudication method for the test set:

   Not applicable. No new clinical study requiring adjudication of a test set was conducted for this 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 device is an intervertebral body fusion device, not a diagnostic or AI-assisted imaging device. Therefore, MRMC studies are not relevant.

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

   Not applicable. This device is a physical implant, not an algorithm or AI system.

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

   For the mechanical and bacterial endotoxin testing, the "ground truth" would be established by:

   • Mechanical Testing: Adherence to established engineering and biomechanical standards (e.g., ISO, ASTM) for strength, durability, and fatigue life of interbody fusion devices. The ground truth is the device's ability to withstand physiological loads and maintain structural integrity.
   • Bacterial Endotoxin Testing: Compliance with the ANSI/AAMI ST72:2011/(R)2016 standard, which sets limits for endotoxin levels to ensure the device is not pyrogenic.

8. The sample size for the training set:

   Not applicable. This is not an AI/ML device requiring a training set.

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

   Not applicable. This is not an AI/ML device requiring ground truth for a training set.

In summary:

This 510(k) notification for the NuVasive MLX and APX systems relies on demonstrating substantial equivalence to previously cleared devices rather than providing a new, comprehensive performance study with explicit acceptance criteria and device performance results. The core of the evidence lies in the technological characteristics, materials, and intended use being similar to existing, legally marketed devices, and referencing prior mechanical test data and current bacterial endotoxin testing to support safety and effectiveness.

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The Vertera Spine™ 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 Vertera Spine 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) 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 Vertera Spine Coalesce Thoracolumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The Vertera Spine Coalesce Thoracolumbar 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 x-ray in vivo.

The purpose of this 510(k) submission is to expand indications for use to match indications for use of the predicate device. NuVasive CoRoent Thoracolumbar System (K170962).

The provided document is a 510(k) premarket notification for a medical device (Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily for extending the indications for use.

Based on the provided text, there is no information regarding acceptance criteria for a study proving the device meets those criteria, nor is there any mention of a study involving AI, human readers, or ground truth establishment in the context of diagnostic performance.

The document states:

• "Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. Since no design changes are a part of the present submission, additional non clinical testing is not warranted. Therefore, no new mechanical testing was performed for this 510(k) submission." (Section G. Performance Data)
• "This device does not contain software or electrical equipment." (Section F. Technological Characteristics)

This indicates that the submission relies on previously conducted mechanical performance testing for the original device and its predicates to demonstrate substantial equivalence, rather than new clinical or diagnostic performance studies for this specific 510(k) (which is for an expanded indication).

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, expert involvement, adjudication, MRMC studies, standalone algorithm performance, or ground truth for the training/test sets, as this type of data is not present in the provided 510(k) summary. The device in question is an intervertebral body fusion system, which are implants, not diagnostic devices that would typically undergo the kind of performance studies you are asking about (related to AI, human readers, or image interpretation).

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