(30 days)
The EVOS Lumbar Interbody System is an intervertebral body device in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.
The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 (per ASTM F-2026) and PEEK Optima LT120HA, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.
The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.
Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.
The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.
The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.
The provided text is an FDA 510(k) premarket notification for the EVOS Lumbar Interbody System. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop performance study.
Therefore, I cannot provide the requested information based on the provided text. The document states:
"No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed." (Page 6, Section VII)
This indicates that the submission relies on the prior clearance of the predicate device and does not include new performance studies or acceptance criteria beyond those relevant for establishing substantial equivalence for a medical device (material properties, dimensions, mechanical performance, etc.), rather than the type of AI-driven performance testing implied by the detailed questions.
To answer your request, a document detailing the clinical or technical performance study of an AI-enabled medical device would be needed.
§ 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.