(217 days)
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of carcellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
The CONCORDE LIFT Expandable Interbody Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion. They are fabricated from titanium alloy (Ti-6Al-4V) per ASTM F136. A cavity internal to each device is intended to hold autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CONCORDE LIFT device is available in both a convex configuration and a lordotic configuration.
The purpose of this submission is to seek clearance for the CONCORDE LIFT devices with lower starting heights.
The provided document is a 510(k) summary for a medical device called the CONCORDE LIFT Expandable Interbody Device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, design, performance, and indications for use, which is a standard regulatory pathway for Class II medical devices like intervertebral body fusion devices. The performance data listed (ASTM standards) relate to the physical and material properties of the implant itself, such as mechanical testing, MRI safety, and bacterial endotoxin testing, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information for an AI/ML device based on the given document. The questions about sample sizes, data provenance, ground truth, experts, adjudication, MRMC studies, and standalone AI performance are not applicable to the content provided.
§ 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.