(30 days)
EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and nano-scale features are intervertebral body fusion devices intented for use for anterior cervical interbody firsion in skeletally mature 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 EIT Cellular Titanium Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion.
EIT Cellular Titanium® ALIF Cage: The EIT Cellular Titanium® ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition reguires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.
EIT Cellular Titanium® TLIF Cage: The EIT Cellular Titanium® TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.
EIT Cellular Titanium® LLIF Cage: The EIT Cellular Titanium & LLF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two configuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confinued by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ETT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
EIT Cellular Titanium® T/PLIF Cage: The EIT Cellular Titanium® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition regures the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondvlolisthesis at the involved level(s). These patients may have had a previous non-firsion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.
The EIT Cellular Titanium® Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes. footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The EIT Cellular Titanium® Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.
The 3D Printed EIT Cellular Titanium® Cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.
The provided text is an FDA 510(k) summary for EIT Cellular Titanium® Cervical and Lumbar Cages. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices for intervertebral body fusion.
It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
The document primarily addresses:
- Device names and regulation numbers.
- Indications for Use.
- Device description (material, manufacturing process).
- Comparison to predicate devices, asserting that the fundamental scientific technology remains unchanged and there's no change to the intended use.
- Stating that performance data remains unchanged compared to predicate devices.
Therefore, I cannot provide details for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document is for a physical implant, not an AI/ML device, so such performance metrics (like accuracy, sensitivity, specificity for an AI algorithm) are not relevant or listed.
- Sample size used for the test set and the data provenance: Not an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI study.
- Adjudication method for the test set: Not an AI study.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not an AI study. The "ground truth" for these devices would typically relate to their mechanical properties, biocompatibility, and clinical outcomes, which are assessed through different types of studies (e.g., mechanical testing, animal studies, clinical trials) not detailed here in terms of acceptance criteria for AI performance.
- The sample size for the training set: Not an AI study.
- How the ground truth for the training set was established: Not an AI study.
In summary, the provided document is a regulatory submission for a spinal implant, not an AI/ML device. Therefore, the specific questions regarding acceptance criteria and study design for an AI/ML device cannot be answered from this text.
§ 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.