(85 days)
EIT Cellular Titanium® Cervical Cages: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices intended for use for anterior cervical interbody fusion 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. The EIT Cellular Titanium® Cervical Cages is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
EIT Cellular Titanium® PLIF Cages: The EIT Cellular Titanium® PLIF Cages 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 or retrolisthesis 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® TLIF Cages: The EIT Cellular Titanium® TLIF Cages 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 or retrolisthesis at the involved level(s). These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis 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® ALIF Cages: The EIT Cellular Titanium® ALIF Cages 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 or retrolisthesis 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.
The purpose of this 510(k) was to update the indications for use to include use at multiple levels (e.g., up to 4 levels) for the EIT Cellular Titanium® Cervical Cages as well as other miscellaneous labeling updates.
The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). 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-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.
The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically intervertebral body fusion devices. It does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.
The document discusses the substantial equivalence of the EIT Cellular Titanium® Cages to previously cleared predicate devices based on indications for use, design, function, materials, and performance. The "Performance Testing Summary" section mentions a "comprehensive, clinical literature review" and "Additional MR-Safety testing" in accordance with ASTM standards, but these are related to the safety and fundamental characteristics of the implantable device, not the performance of an AI/ML algorithm.
Therefore, I cannot extract the information required to answer your prompt, as the prompt's criteria (acceptance criteria for an AI/ML device, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are specific to AI/ML device evaluation, which is not what this document addresses.
The document does not contain information on:
- Acceptance criteria for an AI/ML device's performance.
- A study proving an AI/ML device meets acceptance criteria.
- Sample size used for a test set or data provenance for an AI/ML study.
- Number of experts or their qualifications for establishing ground truth for an AI/ML study.
- Adjudication method for an AI/ML study.
- MRMC comparative effectiveness study or effect size for AI assistance.
- Standalone performance of an algorithm (AI).
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI study.
- Sample size for a training set in an AI context.
- How ground truth for the training set was established for an AI.
§ 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.