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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® 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 MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6Al-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 510(k) covers design changes to MLX - Medial Lateral Expandable Lumbar Interbody System (K140770).

This document is a 510(k) premarket notification for a medical device, the NuVasive® MLX™-Medial Lateral Expandable Lumbar Interbody System. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document only describes nonclinical testing and Finite Element Analysis (FEA) for the device. Clinical data (human subject testing) for a "test set" in the context of device performance in patients (e.g., efficacy, safety) is not mentioned in this 510(k) summary. The testing described is pre-market, bench-top lab testing for mechanical properties and computational analysis.

Therefore, the concepts of "sample size for the test set" and "data provenance (country of origin, retrospective/prospective)" as they relate to human patient data are not applicable to the data presented in this particular 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This information is not applicable as the data presented is from nonclinical (bench and computational) testing, not clinical studies requiring expert ground truth for patient outcomes. The "ground truth" here would be the established ASTM standards and engineering principles for mechanical testing and FEA. Product engineers and test lab personnel with relevant expertise would interpret these results.

4. Adjudication Method for the Test Set

This is not applicable as the document describes nonclinical mechanical and computational testing, not clinical studies that typically involve adjudication of patient outcomes or diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This is not applicable. This 510(k) pertains to a physical medical implant (intervertebral body fusion device), not an AI/software device that would typically undergo MRMC studies for diagnostic accuracy or physician assistance.

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

This is not applicable. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

For the nonclinical performance data, the "ground truth" is based on:

• Established ASTM standards (e.g., F2077, F2063, F136, F1472) for material properties and mechanical testing.
• Engineering principles and Finite Element Analysis (FEA) models for assessing structural integrity and predicting performance under various loads.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" in the context of machine learning or AI. The testing described focuses on evaluating the physical properties and performance of the manufactured device and its design changes.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated in point 8.

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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 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 NuVasive 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 NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System. The NuVasive 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 MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V 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 design changes to NuVasive® Expandable Lumbar Interbody System (K130820).

The NuVasive MLX™ - Medial Lateral Expandable Lumbar Interbody System, as described in the provided 510(k) summary, is a medical device for intervertebral body fusion. The submission does not detail specific acceptance criteria or an analytical study with defined performance metrics in the way one might expect for a diagnostic or AI-driven device.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the primary "acceptance criteria" were met by proving that the modified design of the MLX System device does not introduce new worst-case performance scenarios compared to the established predicates.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The performance data section refers to "Finite Element Analysis (FEA), anterior shear impact testing, torsional separation testing and engineering rationale." These are typically engineering tests performed on a limited number of physical samples or computational models, not a "test set" of patient data as might be relevant for AI or diagnostic devices. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. For a device like the NuVasive MLX, ground truth is typically established through engineering standards, mechanical testing, and regulatory requirements, not through expert review of a "test set" in the context of diagnostic or AI performance.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective expert review (e.g., for image interpretation). For a mechanical device, performance is typically assessed against quantifiable engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices, particularly those involving image interpretation with or without AI assistance, which is not the nature of the NuVasive MLX device.

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

This information is not applicable/not provided. The NuVasive MLX is a physical implantable device, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The ground truth used for this device's "performance" is based on engineering standards, mechanical testing results, and regulatory requirements (substantial equivalence). This includes:

• ASTM and ISO standards for material composition.
• Results from Finite Element Analysis (FEA).
• Results from anterior shear impact testing.
• Results from torsional separation testing.
• Engineering rationale to demonstrate no new worst-case scenarios.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. The NuVasive MLX is a physical medical device, not an AI or software product that undergoes "training."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as point 8.

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The NuVasive 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 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 Expandable Lumbar Interbody System. The Expandable Lumbar Interbody 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 Expandable Lumbar Interbody System is 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.

The provided document describes the NuVasive Expandable Lumbar Interbody System, a Class II medical device intended for intervertebral body fusion of the spine. The evaluation criteria for this device are based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for an AI system. Therefore, many of the requested categories related to AI model evaluation are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for individual tests. The document refers to various "testing" and "cadaver testing" without detailing the number of units or cadavers used.
• Data Provenance: Not explicitly stated. Nonclinical testing was performed, but the location or specific origin of materials/samples is not mentioned. This is a medical device, so the tests would be performed on engineered samples or cadaveric specimens, not retrospective or prospective patient data in the sense of an AI study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. This is a physical medical device clearance, not an AI or diagnostic tool where expert ground truth is established for a test set. The "ground truth" here is compliance with established ASTM standards and comparable performance to predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing involves objective measurements against established technical standards, not subjective expert adjudication.

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 not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI performance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Technical Standards and Predicate Device Performance: The "ground truth" for this device's performance evaluation is established by:
  • ASTM International Standards: F2077 (for static and dynamic mechanical testing), F2129 (for corrosion testing).
  • Performance of Legally Marketed Predicate Devices: The "substantial equivalence" claim is based on demonstrating that the new device performs comparably to the NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359) without introducing new worst-case scenarios.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. This device does not involve an AI model requiring ground truth for a training set.

Summary of the Study:

The study described is a nonclinical performance testing regimen designed to demonstrate the mechanical and material characteristics of the NuVasive Expandable Lumbar Interbody System. The methodologies employed are based on established ASTM standards for intervertebral body fusion devices. The primary objective was to show that the subject device performs similarly to or better than two specific predicate devices already on the market (NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359)) across various mechanical and environmental tests. The conclusion states that the device presents "no new worst-case for performance testing," thereby establishing substantial equivalence to the predicate devices in terms of safety and effectiveness. This type of clearance (510(k)) relies on demonstrating similarity to existing legally marketed devices, rather than establishing de novo safety and effectiveness through extensive clinical trials for software performance.

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