(112 days)
EIT Cellular Titanium® Lumbar Cage LLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed 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. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.
The purpose of this Traditional 510(k) is to seek marketing clearance for the EIT Cellular Titanium® Lumbar Cage LLIF to be added to the EIT Spine line of lumbar interbody cages. The EIT Cellular Titanium® Lumbar Cage LLIF is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with autogenous bone graft and/or allogenic bone graft materials. The EIT Cellular Titanium® Lumbar Cage LLIF is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation. either applied anteriorly or posteriorly (e.g., using posterior pedicle screws).
The EIT Cellular Titanium® Lumbar Cage LLIF is made from Ti-6AI-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft.
The provided text describes a 510(k) premarket notification for a medical device, the EIT Cellular Titanium® Lumbar Cage LLIF. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study design and ground truth cannot be extracted directly from this document.
However, I can extract the acceptance criteria related to performance testing that was conducted and the reported device performance in relation to these tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Standard Applied | Reported Device Performance |
|---|---|---|
| Static Compression | ASTM F2077 | Performance testing per ASTM F2077 and ASTM F2267 was conducted. The document states "The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance." This implies the device met the performance requirements of these standards. The acceptance criteria themselves (e.g., minimum compression strength) are not specified in this document. |
| Static Compression-Shear | ASTM F2077 | Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided. |
| Dynamic Compression | ASTM F2077 | Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided. |
| Dynamic Compression-Shear | ASTM F2077 | Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided. |
| Expulsion | ASTM F2267 | Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided. |
| Subsidence | ASTM F2267 | Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided. |
| Biocompatibility Rationale | ISO 10993 | Biocompatibility rationale comparing the materials used (Ti-6AI-4V ELI) to manufacture the device and instruments with confirmed biocompatibility profiles per ISO 10993 was demonstrated. This suggests that the materials chosen are biocompatible and therefore meet relevant acceptance criteria for safety. Specific test results or numeric acceptance values are not provided. |
| MRI Safety Testing | ASTM F2052-15, ASTM F2213-06, ASTM F2182-11a | Performance testing per ASTM F2052-15, ASTM F2213-06, and ASTM F2182-11a was performed. This implies the device meets the safety requirements for MRI compatibility as defined by these standards. Specific results are not provided but substantial equivalence implies success. |
| Pyrogenicity Testing | Not Specified | Pyrogenicity testing has been completed on the "worst case" EIT lumbar cages. The document states "Equivalence has been established to these EIT lumbar cages and the EIT Cellular Titanium® Lumbar Cage LLIF subject device cages do not introduce a new "worst case" cage. As a result, the pyrogenicity testing completed for the EIT lumbar cage family is applicable to the EIT Cellular Titanium® Lumbar Cage LLIF devices." This implies the device meets pyrogenicity safety standards. Specific acceptance criteria are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission based on mechanical testing and a literature review for an allograft bone material claim. It does not refer to a clinical study with a "test set" of patient data for the device itself.
- Sample Size for Test Set: Not applicable in the context of the provided document as no human clinical study "test set" is described for the device. The "test set" would refer to engineered devices for mechanical, biocompatibility, and MRI safety testing.
- Data Provenance: Not applicable for a clinical test set. The provenance of the testing for the device's physical properties would be from the manufacturer's labs and contracted testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the device's mechanical, biocompatibility, and MRI safety performance is established by the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There's no human-interpreted "test set" that would require an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe an MRMC comparative effectiveness study for the EIT Cellular Titanium® Lumbar Cage LLIF.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on its ability to meet the specifications of the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for mechanical performance, biocompatibility, and MRI safety. The "ground truth" for the claim regarding allogenic bone graft materials comes from a "comprehensive clinical literature review."
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant and there is no mention of a "training set" in the context of machine learning. If referring to manufacturing controls, the sample size would be related to quality control processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set described in the provided document.
§ 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.