(117 days)
The NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL 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. The System is designed for use with 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 Modulus Expandable Posterior Lumbar MOD-EX PL 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 degenerative disc disease (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 Expandable Posterior Lumbar MOD-EX PL Interbody System be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The subject Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System is a thoracolumbar interbody system consisting of an interbody fusion device and associated general instruments. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a posterior (PLIF) or transforaminal (TLIF) 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 Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System interbodies are multi-component devices manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136, Invibio PEEK Optima LT-1 per ASTM F2026, and Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C. 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 endplates of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX PL Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.
This document is a 510(k) K210214 clearance letter for the NuVasive® Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System. It describes the device, its indications for use, and the performance data submitted to demonstrate substantial equivalence to previously cleared devices.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics. Instead, it states that the device was tested to demonstrate "substantial equivalence" to predicate devices, and that the "results demonstrate that the subject NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System meets the same criteria as the predicate devices."
The performance tests performed are listed as follows:
| Test Name | Standard (if applicable) | Reported Device Performance |
|---|---|---|
| Static Compression | ASTM F2077 | Meets same criteria as predicate devices |
| Dynamic Compression | ASTM F2077 | Meets same criteria as predicate devices |
| Static Compression Shear | ASTM F2077 | Meets same criteria as predicate devices |
| Dynamic Compression Shear | ASTM F2077 | Meets same criteria as predicate devices |
| Gravimetric and Particulate analysis | ASTM F1714 and F1877 | Meets same criteria as predicate devices |
| Subsidence and static push-out | N/A | Meets same criteria as predicate devices |
| Bacterial endotoxin testing (BET) | ANSI/AAMI ST72:2011/(R)2016 | Meets same criteria as predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for static compression). The testing appears to be non-clinical performance testing of the device's physical and mechanical properties, not a clinical study involving human patients or data from a specific country. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable in the context of this device's performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device clearance based on non-clinical performance testing and substantial equivalence, not a study involving expert-established ground truth for a test set (e.g., for AI model evaluation).
4. Adjudication Method for the Test Set
Not applicable, as this is non-clinical performance testing, not a clinical study requiring adjudication of human reader interpretations.
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
Not applicable. This document pertains to the clearance of an intervertebral body fusion device and does not involve AI or MRMC studies.
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 software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the performance specifications and criteria of the referenced ASTM and ANSI/AAMI consensus standards, and by the performance characteristics of the predicate devices. The device must meet these established engineering and safety standards to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is non-clinical testing of a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device clearance.
§ 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.