(110 days)
The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine to replace a collapsed, damaged, or unstable disc. The 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options, and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
The provided text describes a 510(k) premarket notification for the "Eminent Spine 3D Lumbar Interbody Fusion Systems." This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than outlining acceptance criteria and a detailed study proving the device meets those criteria in the context of a typical AI/medical device performance study.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
The document mentions "acceptance criteria" not for clinical or diagnostic performance, but for mechanical testing.
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance |
|---|---|
| Static axial compression per ASTM F2077 | Device performs as well as or better than acceptance criteria. |
| Static axial compression-shear per ASTM F2077 | Device performs as well as or better than acceptance criteria. |
| Dynamic axial compression per ASTM F2077 | Device performs as well as or better than acceptance criteria. |
| Dynamic axial compression-shear per ASTM F2077 | Device performs as well as or better than acceptance criteria. |
| Subsidence per ASTM F2267 | Device performs as well as or better than acceptance criteria. |
| Expulsion | Device performs as well as or better than acceptance criteria. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to mechanical testing, not clinical studies involving patient 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 information is not applicable as the document describes mechanical testing of an implantable device, not an AI or diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes mechanical testing.
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
This information is not applicable as the document describes mechanical testing of an implantable device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes mechanical testing of an implantable device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be established by the physical testing standards (ASTM F2077, ASTM F2267) and their specified measurement methods and acceptable limits. It's not a biological "ground truth" as typically discussed in diagnostic studies.
8. The sample size for the training set
This information is not applicable as the document describes mechanical testing of a physical device, not an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable as the document describes mechanical testing of a physical device.
Summary of the Study:
The "study" described in this 510(k) summary is a series of mechanical tests designed to ensure the Eminent Spine 3D Lumbar Interbody Fusion Systems possess adequate strength and stability for their intended use. These tests were conducted according to ASTM standards (F2077 for static and dynamic testing, F2267 for subsidence), and an additional test for expulsion. The conclusion is that the device "performs as well as or better than the chosen acceptance criteria," which are implicitly defined by compliance with these ASTM standards and any internal specifications. The purpose of these tests is to demonstrate that the new device is mechanically equivalent to the predicate devices and safe for its intended surgical application, not to evaluate diagnostic performance or AI effectiveness.
§ 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.