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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 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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