(120 days)
The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.
The Endoskeleton® TC is a cervical intervertebral body fusion device. The system is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The center of the implant is hollow and is to be filled with autograft material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.
This document is a 510(k) summary for the Endoskeleton® TC intervertebral body fusion device. It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices. Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML device.
The provided text describes a traditional medical device (an implantable fusion device) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already marketed predicate devices through mechanical testing. It does not mention any AI/ML components, software, or algorithms. Therefore, it's impossible to extract the requested information regarding AI/ML device performance, ground truth, expert consensus, or comparative effectiveness studies from this document.
Based on the provided text, I cannot complete the requested tables and descriptions because the document pertains to a physical medical device (an intervertebral body fusion device) and does not describe an AI/ML powered device or a study involving such a device.
The summary focuses on:
- Device Description: A titanium intervertebral body fusion device.
- Intended Use: Anterior cervical interbody fusion for degenerative disc disease.
- Predicate Devices: Other legally marketed interbody devices.
- Non-Clinical Testing: Mechanical tests like axial compression, shear, torsion, subsidence, and expulsion, all performed in vitro (e.g., in a lab setting, not on patient data or with AI).
- Substantial Equivalence: A regulatory pathway showing the new device is as safe and effective as existing ones, primarily based on design, materials, and mechanical 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.