(267 days)
The Avenue® T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.
The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous bone graft for fusion.
After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral titanium locking pin.
The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.
The Avenue T cages are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.
The provided text describes a medical device (Avenue T® TLIF Cage) and its FDA clearance. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance, which is what your request is focused on. This document is a 510(k) summary for a physical medical implant, not an AI or software as a medical device.
Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars for AI-related performance. The document explicitly states:
- "Clinical testing was not required to demonstrate substantial equivalence." This means no human clinical trials were performed to assess patient outcomes or the device's clinical effectiveness in a real-world setting.
- "Non-clinical performance bench testing conducted to support substantial equivalence for the Avenue T TLIF Cage included: ... The results of this non-clinical testing demonstrate that the strength of the Avenue T TLIF Cage is sufficient for its intended use and is therefore substantially equivalent to legally marketed predicate devices." The "acceptance criteria" here refer to engineering and biomechanical tests comparing the device to existing predicate devices, not performance against clinical endpoints or AI metrics.
The information you are asking for, such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, and ground truth types, are standard for AI/software medical devices undergoing regulatory review, but are not applicable to the documentation provided for this physical implantable device.
§ 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.