(28 days)
The Keos Lumbar IBFD is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) of the spine. 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 I 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 and rod systems, anterior plate systems, 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 transforaminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.
The Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion (IBF). 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.
Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are made from PEEK radiolucent material and Hydroxyapatite (HA) Enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
Surgical instruments are required for implantation of the device. The accessories are manufactured from 17-4 Stainless Steel (per ASTM F899-11), 465 Stainless Steel, Silicon, 6061 Aluminum, 300 and 400 Series Stainless Steel.
I apologize, but the provided text from the FDA 510(k) clearance letter for the Keos Lumbar IBFD does not contain any information about acceptance criteria or a study proving the device meets performance criteria for an AI/software as a medical device (SaMD).
The document is a clearance letter for a physical medical device (an intervertebral body fusion device) and focuses on its substantial equivalence to a predicate physical device. It describes:
- The device name, regulation, and product code.
- The indications for use of the physical implant.
- The materials and manufacturing of the physical implant and surgical instruments.
- A statement about "Confirmatory testing, including impaction, as well as rationales were provided to demonstrate substantial equivalence." (This refers to mechanical and material testing, not AI performance).
Therefore, I cannot provide the requested table and study details as they are absent from the provided text.
If you have a different document that describes an AI/SaMD for which you need this information, please provide that text.
§ 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.