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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 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 bone graft to facilitate fusion. The AP Expandable XLIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/ rod systems) that are cleared by the FDA for use in the lumbar spine.

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 bone graft to facilitate fusion. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive Sterile MLX and APX Interbody Devices are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6AI-4V conforming to ASTM 1472, Nitinol SE508 conforming to ASTM F2063, and Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers addition of sterile packaged implants to previously cleared systems.

This document is about the FDA 510(k) clearance of the NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System and NuVasive® AP Expandable XLIF System. It does not describe an AI medical device or a study proving its performance. Thus, I cannot provide the requested information.

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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 bone graft to facilitate fusion.

The AP Expandable XLIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.

The NuVasive AP Expandable XLIF System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3 and Ti-6Al-4V conforming to ASTM 1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) Summary for the NuVasive® AP Expandable XLIF System, an intervertebral body fusion device. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to establish performance criteria through a clinical study involving AI or human readers.

Therefore, the requested information components related to acceptance criteria, ground truth, sample sizes for test and training sets, expert adjudication, and multi-reader multi-case (MRMC) studies are not applicable to the content provided in this 510(k) summary. These components are typically associated with performance evaluations of AI/ML-driven devices or clinical trials, neither of which are described here.

The document focuses on demonstrating substantial equivalence through nonclinical testing and comparison to predicate devices, as is standard for many Class II medical devices seeking 510(k) clearance.

Here's the relevant information based on the provided text, addressing the request by noting the inapplicability of many points:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No "test set" in the context of AI/ML or clinical data performance evaluation is described. The performance data refers to nonclinical (mechanical) testing of the physical device.

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

Not applicable. No "ground truth" derived from expert review of data is established for this type of nonclinical testing.

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

Not applicable. No "adjudication method" is described as there is no human review of data to establish ground truth.

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 a physical implant, not an AI-driven diagnostic or assistive system. No MRMC study was performed or is 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.

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

Not applicable. The "ground truth" for the performance data in this context is based on engineering specifications and physical measurements compliant with ASTM standards, not clinical ground truth like pathology or expert consensus. The comparison is against predicate devices and their established performance characteristics.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no "training set."

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

Not applicable. There is no AI/ML model, and therefore no "training set" or corresponding ground truth establishment process.

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