(100 days)
The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine.
The ORIO-Ti lumbar intervertebral body fusion cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.
The subject devices are intervertebral body fusion devices for use in cervical lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally boxshaped or trapezoidal shaped with windows or pockets in their design to allow for the placement of autograft or allogenic bone graft. The ORIO-Ti Cage System is a Titanium alloy interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: as a single device via an anterior cervical (ACDF), bilaterally in pairs via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via an anterior (ALIF) approach. The exterior of the devices has "teeth" on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.
The provided text is a 510(k) summary for the ORIO-Ti Intervertebral Body Fusion Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.
Crucially, the document explicitly states under "8. Clinical Test Summary": "No clinical studies were performed."
Therefore, it is not possible to provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as no clinical studies were conducted for this device. The information provided heavily emphasizes non-clinical testing and comparison to predicate devices, which is common for 510(k) submissions where clinical data is often not required if substantial equivalence can be demonstrated through other means.
Without clinical study data, none of the points you asked for (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set ground truth establishment) can be answered.
§ 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.