(29 days)
The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.
The F3D™ Lateral System is part of the Foundation 3D Interbody System. The purpose of this Special 510(k) is to add sizes and lordotic angles to the system. The cages are additively manufactured implants made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F136 specifications. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.
The provided documentation is a 510(k) premarket notification for a medical device called the "CoreLink F3D™ Lateral System." The purpose of this submission is not to present a study proving the device meets acceptance criteria related to an AI/ML algorithm's performance. Instead, it describes a Class II medical device (intervertebral body fusion device) that is being submitted for substantial equivalence to existing predicate devices.
The "Performance Testing" section mentions "FEA was performed to demonstrate that the modified geometries of the cage did not change the worst case device in the system" and "The information summarized in the Design Control Activities Summary demonstrates that the modified geometries of the cage meet the pre-determined acceptance criteria for the verification activities."
This indicates that the performance testing here is for the mechanical and structural integrity of the intervertebral body fusion device, not for the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information because the document does not describe the acceptance criteria and study proving an AI/ML device meets acceptance criteria. The device described is a physical implant, not an AI/ML product.
§ 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.