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The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. When ≥20° lordosis is needed, the plated MOD-EX XLIF interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.

The MOD-EX XLIF 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 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 thoracy 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 MOD-EX XLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis and sagittal deformity.

The NuVasive MOD-EX XLIF Interbody System is an expandable interbody system additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C and traditionally manufactured from both titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3 and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. MOD-EX XLIF interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The device features independent threaded drive and wedge mechanisms to allow for independent expansion of the anterior and posterior aspect of the implant. The superior and inferior endplate components are solid and porous structures manufactured simultaneously using a powder bed fusion method. The microporous, textured surfaces on the superior and inferior ends of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX XLIF Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.

The provided text is a 510(k) Pre-market Notification for the NuVasive® MOD-EX XLIF Interbody System. This document focuses on demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices, rather than performing a clinical study to establish acceptance criteria based on human expert performance or clinical outcomes.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance against those criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types in the context of an AI/software device.

The "Performance Data" section (Page 4, Section G) refers to non-clinical mechanical testing performed to demonstrate substantial equivalence to predicate devices, not clinical performance metrics relevant to AI algorithms or human reading tasks.

• Acceptance Criteria and Reported Device Performance: This information is not present. The document focuses on mechanical testing demonstrating substantial equivalence to predicate devices, not on pre-defined clinical acceptance metrics.
• Sample size used for the test set and the data provenance: Not applicable, as this is a mechanical engineering equivalence study, not an AI/clinical performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study was not performed or referenced.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for spinal fusion, not an AI algorithm.
• The type of ground truth used: Not applicable. The "ground truth" here would be established mechanical engineering standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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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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