(318 days)
The Innovasis AXTiTM Titanium Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AXTi™ Titanium Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AXTi implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The Innovasis AXTi™ Titanium Stand-Alone ALIF System features a sterile packaged single use implant and associated reusable instrumentation for preparation of the surgical site and implantation of the device provided. The instruments and fixation screws are provided in storage trays for organization and steam sterilization.
The AXTi Titanium Stand Alone ALIF features all titanium (6Al 4V ELI) implant body and bone screws for fixation. The implant is a stand-alone anterior intervertebral body fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The implant body is provided sterile.
The interior of the device will be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The device is intended to support restoration of the sagittal balance.
It is intended to be used with all three internal fixation bone screws and will not require additional supplementary fixation for implants with a lordotic angle less than 20°.
Implants with a lordotic angle ≥20° are indicated for use with supplementary fixation, such as the Excella® Spinal System.
It is intended for use with the standard anterior (ALIF) approach
The provided text describes a 510(k) premarket notification for a medical device, the AXTi™ Titanium Stand-Alone ALIF System, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding the acceptance criteria or a study that proves a device meets AI/Machine Learning performance acceptance criteria.
The "Performance Data" section explicitly states "(Non-clinical)-Performance testing per ASTM F2077-14 and F2267-04 for Static Axial Compression. Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Subsidence and Expulsion testing indicates that the AXTi Titanium Stand-Alone ALIF is substantially equivalent to the predicates." This refers to mechanical and physical performance testing of the intervertebral fusion device itself, not the performance of an AI or Machine Learning algorithm.
Therefore, I cannot populate the requested table or answer the questions related to AI/Machine Learning performance, ground truth, expert review, or MRMC studies based on the provided input. The document describes a physical medical device, not an AI-powered one.
§ 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.