(140 days)
EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. 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® PLIF Cages: The ET Cellular Titanium® PLF 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 nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® TLIF Cages: The ETT 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 discogemic 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 nonoperative treatment prior to 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 discogenc 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 nonoperative treatment prior to treatment with the devices.
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 describes a medical device submission (K170503) for various EIT Cellular Titanium® Cages, which are intervertebral body fusion devices. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document states that the devices were subjected to mechanical testing. The acceptance criteria are implicitly the standards outlined in ASTM F2077-14 and F2267-04. The reported device performance is that the "results demonstrate that the devices are substantially equivalent to the predicate devices." No specific numerical results or detailed performance metrics are given in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Static compression (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Static compression-shear (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Dynamic compression (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Dynamic compression-shear (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Torsion (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Dynamic Torsion (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Expulsion (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Subsidence (per ASTM F2077-14 and F2267-04) | Devices met the standards, demonstrating substantial equivalence to predicate devices. |
| Bacterial endotoxin testing (as part of sterilization process) | Devices met the standards, demonstrating substantial equivalence to predicate devices. (No specific thresholds are provided for bacterial endotoxin limits in this extract). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size for the mechanical testing (e.g., number of devices tested for each type of cage and test). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as this is a regulatory submission summary focusing on equivalence rather than a clinical trial. The testing is described as "Performance Testing Summary," indicating laboratory mechanical tests rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This document describes mechanical testing of medical implants, not a diagnostic or prognostic device that would require human expert-established ground truth. Therefore, this information is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As this involves mechanical testing of physical devices against material and performance standards (ASTM standards), there is no adjudication method in the context of expert review for ground truth establishment. The evaluation is based on whether the devices physically meet the specified mechanical requirements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was conducted. This device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was done. This document pertains to a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards, specifically ASTM F2077-14 and F2267-04 for mechanical properties, and bacterial endotoxin testing for sterility. There is no biological or diagnostic "ground truth" as would be established by pathology or clinical outcomes in the context of a diagnostic device.
8. The sample size for the training set:
Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets.
9. How the ground truth for the training set was established:
Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets and ground truth for them.
§ 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.