(129 days)
Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Keos Lumbar IBFD can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.
The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
Here's an analysis of the provided text regarding the Keos Lumbar IBFD and its acceptance criteria, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static Compression Test (per ASTM F2077) | Met the acceptance criteria. |
| Dynamic Compression Test (per ASTM F2077) | Met the acceptance criteria. |
| Material Characterization (Effects of Cleaning): | |
| X-ray Diffraction (XRD) evaluation | Used to evaluate the effects of cleaning on the implants. The results showed the Keos Lumbar IBFD met the acceptance criteria. (Implies no detrimental alterations from cleaning based on XRD). |
| Fourier Transform Infrared Spectroscopy (FTIR) | Used to evaluate the effects of cleaning on the implants. The results showed the Keos Lumbar IBFD met the acceptance criteria. (Implies no detrimental alterations from cleaning based on FTIR). |
| X-ray Photoelectron Spectroscopy (XPS) | Used to evaluate the effects of cleaning on the implants. The results showed the Keos Lumbar IBFD met the acceptance criteria. (Implies no detrimental alterations from cleaning based on XPS). |
| Sterilization: | |
| Sterility Assurance Level (SAL) of 10⁻⁶ (implants) | Validation testing of the autoclave process (half-cycle method) conducted per ISO 17665 achieved a SAL of 10⁻⁶ for implants. (Implies the device can be effectively sterilized to this level). |
| Sterility Assurance Level (SAL) of 10⁻⁶ (instruments/case) | Validation testing of the autoclave process (half-cycle method) conducted per ISO 17665 achieved a SAL of 10⁻⁶ for instruments and case. (Implies the associated instruments and case can be effectively sterilized to this level). |
2. Sample Size for the Test Set and Data Provenance
The document does not provide specific sample sizes for the mechanical tests (Static and Dynamic Compression Tests) or the material characterization tests (XRD, FTIR, XPS). It only states that these tests were performed and the device met the acceptance criteria.
The data provenance is not specified (e.g., country of origin). Since these are material and mechanical bench tests, the concept of "retrospective or prospective" data provenance, as it typically applies to clinical studies, is not directly relevant here. These are laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for these tests (mechanical and material characterization) is the established standard (e.g., ASTM F2077 for compression, ISO 17665 for sterilization) and the objective measurements derived from the tests themselves, rather than expert consensus on a clinical outcome.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation where there's subjectivity and disagreement among human reviewers to establish a consensus ground truth. The tests mentioned are objective laboratory tests.
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
An MRMC study was not conducted. This device is an Intervertebral Body Fusion Device (implantable medical device), not an AI-powered diagnostic or assistive tool for human readers. No mention of AI or human reader improvement is present.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was performed.
7. The Type of Ground Truth Used
The ground truth used for the nonclinical tests was primarily:
- Standardized Test Methods: Adherence to established industry standards like ASTM F2077 for mechanical testing and ISO 17665 for sterilization validation.
- Objective Measurement Data: The results of the laboratory tests (e.g., force, displacement, spectral data) compared against defined pass/fail criteria within those standards.
- Material Specifications: Compliance with material standards (e.g., ASTM F2026 for PEEK-OPTIMA and ASTM F560 for tantalum x-ray markers).
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This device is a physical implant for which safety and effectiveness are shown through nonclinical (bench) testing and substantial equivalence to a predicate device, not through machine learning model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no training set.
§ 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.