(197 days)
The Brigade Hyperlordotic System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Brigade Hyperlordotic System is intended for use with autograft. The Brigade Hyperlordotic System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Brigade Hyperlordotic System.
The NuVasive Brigade Hyperlordotic System is an interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Hyperlordotic System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Hyperlordotic intervertebral fusion device is a device composed of a PEEK interbody implant containing radiographic titanium alloy markers, and four (4) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMA LT1) conforming to ASTM F-2026 and titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.
The NuVasive® Brigade® Hyperlordotic System is an intervertebral body fusion device. The provided text describes the nonclinical testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study establishing performance against specific acceptance criteria for a new clinical endpoint.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Standard / Parameter | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Static & Dynamic) | Static and dynamic compression, torsion, and compression shear testing per ASTM F2077 | All test results passed acceptance criteria |
| Expulsion Resistance | Expulsion testing per ASTM Work Item Z8423Z | All test results passed acceptance criteria |
| Subsidence Resistance | Subsidence testing per ASTM F2267 | All test results passed acceptance criteria |
| Biocompatibility/Material Integrity | Wear debris/mass change analysis during ASTM F2077, per ASTM F1714 and ASTM F1877 | All test results passed acceptance criteria |
| Screw Fixation Strength | Screw push-out testing | All test results passed acceptance criteria |
| Overall Performance | Meets or exceeds the performance of the predicate device and does not introduce any new risks | System is substantially equivalent to the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document details nonclinical (preclinical) testing, not a clinical study with a "test set" of patients. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided. The tests mentioned are laboratory-based mechanical and material assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for the nonclinical tests is based on established engineering standards (e.g., ASTM standards) and the performance of the predicate device for comparison. There is no mention of expert adjudication for these engineering tests.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as this was a nonclinical study based on standardized tests.
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
No MRMC study was performed or mentioned. This device is a physical intervertebral body fusion device, not an AI-based diagnostic or assistive software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical implant.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests was based on established engineering standards (ASTM and ISO) and the performance metrics of the legally marketed predicate devices. The goal was to demonstrate that the subject device's performance meets or exceeds these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and the testing described is nonclinical. There is no "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.