(120 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain or improve mechanical performance compared to predicate devices, without introducing new worst-case scenarios. | Modifications to the MLX System were shown not to create new worst-case scenarios for performance. |
| Substantial equivalence in design, intended use, material composition, and function to predicate devices. | The subject device was found to be substantially equivalent to predicates in these areas. |
| Biocompatibility of materials. | Materials (Ti-6AI-4V ELI, Ti-6A1-4V, Nitinol SE508, Nickel-Cobalt-Chromium-Molybdenum alloy) conform to ASTM and ISO standards. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.