(371 days)
The Omnia Medical TiBrid™ Cervical Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have had at least six weeks of non-operative treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.
The Omnia Medical TiBrid™ ALIF, PLIF, TLIF and Lateral Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis 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. Patients should have had at least six months of non-operative treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.
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This document is a 510(k) clearance letter for the Omnia Medical TiBrid™ Cervical Cage, Omnia Medical TiBrid™ Lateral Cage, Omnia Medical TiBrid™ ALIF Cage, Omnia Medical TiBrid™ PLIF Cage, and Omnia Medical TiBrid™ TLIF Cage. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does NOT contain any information about acceptance criteria, device performance testing, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.
Therefore, I cannot provide the requested information from this document.
To answer your request, I would need to analyze a different part of the 510(k) submission, specifically the sections that detail the performance data and testing conducted to demonstrate substantial equivalence.
§ 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.