(98 days)
The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C Cervical Intervertebral Body Fusion Device or anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C Cervical Intervertebral Body Fusion and with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and or craft to faciliate fusion. Non-operative treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach approach.
Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
Talos®-C(HA) Cervical Intervertebral Body Fusion Devices
The Talos®-C(HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fuss are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. Non-operative tratment pror to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) Veeks. Talos®-C(HA) Cervices are to be implemented via an open anterior approach approach.
Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperloriotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.
The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.
The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.
The provided document is a 510(k) premarket notification letter and summary for a medical device (Talos®-C Cervical Intervertebral Body Fusion System). It does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.
The document details the device's indications for use, technological characteristics, and non-clinical testing (mechanical tests like compression, shear, torsion, and subsidence testing, as well as Finite Element Analysis) to demonstrate substantial equivalence to predicate devices for spinal fusion.
**Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML study.**
This submission is for a physical implantable device, not a software or AI-based diagnostic/treatment system. The "testing" mentioned refers to biomechanical performance of the implant, not performance metrics related to diagnostic accuracy or AI model output.
§ 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.