(148 days)
Cervical System Indications:
The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.
This submission is to add additional ACIF configurations to the Tyber Medical PT Interbody System and corresponding trials. Additionally, the Indications for Use are being revised.
The new configurations will be manufactured from PEEK – Optima® and plasma sprayed with commercially pure titanium coating, identical to the existing devices in the system. The new ACIF configurations have superior and inferior surfaces that are inclined at larger angles than the existing configurations. In addition, a new extra-large configuration for these sizes will be included. Other geometries, such as the open lumen area and teeth geometry on the superior and inferior surfaces remain identical to the devices within the Tyber Medical PT Interbody System.
The trials will be manufactured from stainless steel and will incorporate trial geometries that match the corresponding implant.
The provided document is a 510(k) summary for the Tyber Medical PT Interbody Spacer System, which is a medical device. This document does NOT contain information about an AI/ML device or any study involving human readers and AI assistance. Therefore, I cannot generate a response that includes information related to acceptance criteria for an AI device, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance.
The document details the substantial equivalence of new configurations of an intervertebral body fusion device to previously cleared predicate devices. The performance data presented are for non-clinical mechanical tests (static, dynamic compression, shear, torsion, and expulsion testing) and pyrogenicity testing, which are standard for this type of medical implant. Clinical data was explicitly stated as "not needed for this device."
To reiterate, the provided text does not describe an AI/ML device, its acceptance criteria, or studies related to its performance in the context of human-AI interaction or standalone AI performance.
§ 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.