(140 days)
Expandable Lumbar Fusion Cage (Type I , Type II ) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine(L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Expandable Lumbar Fusion Cage (Type II) are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Posterior Spinal Fixation System.
The Expandable Lumbar Fusion Cage system is a kind of fusion device for thoracolumbar and spinal stability. The main indication of this product is spinal fusion for spinal operation. The components of system are made of titanium alloy. The Expandable Lumbar Fusion Cage system is used by trained orthopaedic surgeons and/or neurosurgeons in a standard operating environment. The Expandable Lumbar Fusion Cage system provides a wide range of implants, including different widths, heights, lengths and angles to choose from.
The provided text does not describe a study involving AI or software for diagnostic or prognostic purposes. The device in question is an "Expandable Lumbar Fusion Cage (Type I, Type II)", which is an intervertebral body fusion device used in spinal surgery.
Therefore, the requested information regarding acceptance criteria, performance data from an AI study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not applicable to this submission.
The "Performance Data" section (Page 4, Section 7) clearly states:
"Mechanical testing (static and dynamic compression, static and dynamic compressionshear per ASTM F2077 and subsidence per ASTM F2267) was conducted to demonstrate substantial equivalence to the predicate device."
This indicates that the device's performance was evaluated through physical mechanical testing to confirm its structural integrity and safety, not through a study involving AI or software analysis of medical images or data.
In summary, none of the requested information regarding AI device acceptance criteria and study details can be extracted from the provided FDA submission document because the device is a physical implant, not an AI-powered diagnostic or prognostic tool.
§ 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.