(91 days)
The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade® Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Brigade® Lateral System is interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade® Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The NuVasive® Brigade® Lateral System is an interfixated interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Lateral System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Lateral System intervertebral fusion device is composed of a PEEK interbody implant containing radiographic titanium alloy markers, and two (2) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMAL LT1) conforming to ASTM F2026 and titanium alloy (Ti-6A-4V ELI) conforming to ASTM F136 and ISO 5832-3 or (Ti-6A-4V) conforming to ASTM F1472. The purpose of this Premarket Notification in to implement design changes to the Brigade System previously cleared in K161230 (NuVasive® Lumbar Interbody Implant).
This document is a 510(k) premarket notification for the NuVasive® Brigade® Lateral System, an intervertebral body fusion device. It does not describe a study involving an AI/ML device or its acceptance criteria. Therefore, most of the requested information cannot be extracted from this document regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML device.
However, I can extract information related to the device itself and its regulatory approval process, which is the context of the provided text.
Here's what can be extracted from the document:
Device Information:
- Trade/Device Name: NuVasive® Brigade® Lateral System
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral Body Fusion Device
- Regulatory Class: Class II
- Product Code: OVD
- K Number: K181386
- Date Prepared: May 24, 2018
- Applicant: NuVasive, Incorporated
- Indications for Use: The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients across L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. It must be used with supplemental internal spinal fixation systems and autogenous and/or allogeneic bone graft. It can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. Devices are for patients who have had at least six months of non-operative treatment.
- Device Description: An interfixated interbody system made from PEEK and titanium alloy, available in various shapes and sizes. It consists of a PEEK interbody implant with radiographic titanium alloy markers and two titanium alloy bone screws.
- Predicate Devices:
- Performance Data: Finite Elemental Analysis (FEA) and engineering rationale were provided to demonstrate that the modified design did not create a new worst-case scenario. This data concludes the device is substantially equivalent to predicate devices.
- Clinical Studies: No non-clinical or clinical studies were conducted for this 510(k) submission.
Regarding your specific questions, this document does not contain the following information as it pertains to an interbody fusion device, not an AI/ML device:
- A table of acceptance criteria and the reported device performance: Not applicable. Performance was shown through substantial equivalence to predicates via FEA and engineering rationale, not specific performance metrics against acceptance criteria for an AI/ML device.
- Sample sizes used for the test set and the data provenance: Not applicable. No test set for an AI/ML algorithm was described.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this device is not an AI algorithm that would typically undergo such a study.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. Ground truth typically refers to data labeling for AI/ML.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.