(87 days)
The ASTRAEUS anterior lumbar interbody fusion device is a member of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous bone graft.
GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach.
The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach.
The THEMIS Transforaminal posterior lumbar is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with disc disease (DDD) at one or two contiquous 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
The GAIA Lumbar Interbody Fusion Device (LIFD) Family consists of the ASTRAEUS ALIF, the PROMETHEUS PLIF, and the THEMIS TPLIF.
The ASTRAEUS anterior lumbar interbody fusion (ALIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The ASTRAEUS ALIF devices are to be implanted via an anterior approach.
The PROMETHEUS posterior lumbar interbody fusion (PLIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The PROMETHEUS PLIF devices are to be implanted via a posterior approach.
The THEMIS transforaminal posterior lumbar interbody fusion (TPLIF) implants are interbody fusion devices intended for use an aid in spinal fixation and provided structural stability in skeletally mature patients. THE THEMIS TPLIF devices are to be implanted via a transforaminal or posterior approach.
The GAIA Lumbar Interbody Fusion Device (LIFD) Family implants are manufactured additively from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are offered in a variety of standard sizes (width, length, height, lordotic angle) designed to adapt to many different patient anatomy. Each interbody device has an axial graft window to allow bone grafting material of autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to be placed inside the interbody. Various interbody window lattices are provided to adapt to various bone graft placement methods. High friction surfaces with protrusions on superior and inferior of the interbody fusion device grip the end plates of adjacent vertebrae to resist expulsion or other unintended migration of the implants provide an alternative to autogenous bone graft blocks and assist to reduce complications related to bone graft.
This document describes the GAIA Lumbar Interbody Fusion Device (LIFD) Family, which includes the ASTRAEUS ALIF, PROMETHEUS PLIF, and THEMIS TPLIF devices. These devices are intended for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, and may also be used in patients with up to Grade 1 spondylolisthesis or retrolisthesis, or degenerative scoliosis. They are designed to be used with autogenous and/or allograft bone graft and supplemental spinal fixation systems.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GAIA Lumbar Interbody Fusion Device (LIFD) Family are based on mechanical strength testing to ensure suitability for its intended use and substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated in the provided text, the reported performance indicates the device meets these criteria by being "sufficient for its intended use and substantially equivalent to legally marketed predicate devices."
| Acceptance Criteria Category | Specific Test Standard | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Static Axial Compression | Sufficient for intended use; substantially equivalent to predicate devices |
| Dynamic Axial Compression | Sufficient for intended use; substantially equivalent to predicate devices | |
| Static Compression Shear | Sufficient for intended use; substantially equivalent to predicate devices | |
| Dynamic Compression Shear | Sufficient for intended use; substantially equivalent to predicate devices | |
| Subsidence (per ASTM F2267-04 (2018)) | Sufficient for intended use; substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the mechanical tests (static and dynamic axial compression, static and dynamic compression shear, and subsidence). The data provenance is derived from "non-clinical testing" conducted on the GAIA Lumbar Interbody Fusion Device (LIFD) Family. Further details regarding the testing facility or specific country of origin are not provided, nor is whether the data is retrospective or prospective, though non-clinical testing is inherently prospective for device clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The GAIA Lumbar Interbody Fusion Device (LIFD) Family is a physical medical device, and its performance evaluation for FDA clearance (510(k)) relies on non-clinical mechanical testing results, not on expert-established ground truth related to diagnostic or interpretive tasks.
4. Adjudication Method for the Test Set
This section is not applicable, as the evaluation method is based on objective mechanical testing against defined standards, not on subjective assessment or adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The provided information pertains to the clearance of a physical medical device (interbody fusion device) based on mechanical performance, not a diagnostic or AI-assisted system that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device in question is a physical interbody fusion device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by the specified ASTM international standards (ASTM F2077-18 for axial compression and compression shear, and ASTM F2267-04 (2018) for subsidence). These standards define acceptable mechanical properties and performance criteria for intervertebral body fusion devices. The device's performance is evaluated against these engineering standards.
8. The Sample Size for the Training Set
This section is not applicable. The GAIA Lumbar Interbody Fusion Device (LIFD) Family is a physical medical device. There is no "training set" in the context of mechanical testing for a physical device, unlike in the development of AI or diagnostic algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable, as there is no training set for a physical medical device.
§ 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.