(472 days)
The Titus Titanium Cervical by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Titus Titanium Cervical by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The Titus Titanium Cervical by SAGICO is designed in a manner to be used with additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
The Titus Titanium Cervical by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The Titanium Cervical by SAGICO, is intended to be used at one disc level from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Titus Titanium Cervical by SAGICO incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The Titus Titanium Cervical by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. The Titus Titanium Cervical by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Titus Titanium Cervical by SAGICO." This document is a regulatory filing for a medical device and describes its intended use, design, and comparison to legally marketed predicate devices to establish substantial equivalence.
**Crucially, this document does not describe:
- A study proving the device meets acceptance criteria.** Instead, it lists non-clinical performance data testing (like ASTM standards for static and dynamic compression, torsion, and pullout tests) that was conducted to support the claim of substantial equivalence. These are engineering and material tests, not clinical studies with patients or image-based diagnostic performance studies.
- Acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" discussed implicitly are related to the mechanical and material properties of the implant, ensuring it functions safely and effectively as an intervertebral body fusion device.
- Any human-in-the-loop (MRMC) studies or standalone algorithm performance. This is an implantable medical device, not an AI/ML-based diagnostic software.
- Ground truth establishment for diagnostic purposes or expert review processes.
Therefore, I cannot extract the information requested as it pertains to AI/ML diagnostic device performance studies. The document describes a physical medical device (an intervertebral body fusion device), not an imaging or diagnostic AI. The "K221138" is a 510(k) clearance number for an implant, not for a diagnostic algorithm.
If the request was for a different type of document (e.g., an FDA clearance for an AI-powered diagnostic device), I would be able to provide the requested information, assuming it was present in that document.
§ 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.