(30 days)
When used as an Intervertebral Body Fusion device, the RODIN Expandable Lumbar Cage System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The RODIN Expandable Lumbar Cage System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
When used as a Vertebral Body Replacement device, the RODIN Expandable Lumbar Caqe System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The RODIN Expandable Lumbar Cage System is intended for use with autograft and/or allograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
The RODIN Expandable Lumbar Cage System is an intervertebral body fixation system and vertebral body replacement consisting of implants with various widths, heights, and lordosis to accommodate individual patient pathology. The devices are intended to deploy using CTL Medical instruments once placed into the spinal interbody space. System implants and instruments are manufactured from implant grade titanium (Ti-6AI-4V ELI per ASTM F136) and surgical grade stainless steel and silicone rubber respectively. The implants consist of tantalum markers (per ASTM F560) that enable viewing the implant position under imaging. These implants are intended for use with supplemental spinal fixation and bone graft. The implants are provided in both sterile and non-sterile configurations.
I am sorry. I cannot provide the acceptance criteria and study information based on the input text. The provided text is a 510(k) summary for a medical device (RODIN™ Expandable Lumbar Cage System) and does not contain details of specific performance criteria or a clinical study evaluating the device's performance against such criteria.
The document explicitly states: "No additional bench testing was deemed necessary for the subject device as there is no major change in design and technology as compared to the predicate device. The bench testing submitted in the predicate device 510(k) K160646 is still applicable to the subject device."
This indicates that the submission relies on the testing and performance data of its predicate device (K160646, XYcor Expandable Spinal Spacer System) to demonstrate substantial equivalence, rather than presenting a new study for the RODIN™ system itself.
Therefore, the requested information, such as a table of acceptance criteria and reported device performance, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, and training set details, is not available within the provided text.
§ 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.