(155 days)
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.
The Vy Spine™ LumiVy™ Lumbar IBF System is comprised of implants components. The implant component, the Vy Spine™ LumiVy™ Lumbar IBF System device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Vy Spine™ LumiVy™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body.
The provided text is a 510(k) summary for the Vy Spine™ LumiVy™ Lumbar IBF System. It details the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed. However, it does not contain information about studies involving acceptance criteria and device performance in the context of AI or specific performance metrics typically associated with medical device studies involving such criteria (e.g., sensitivity, specificity, accuracy).
The "Non-Clinical Testing" section explicitly states that the RELIANCE Lumbar IBF System (the predicate device) underwent "various ASTM Standard tests at a third party facility," and that the subject device "has similar design, sizes, indication of use & biocompatibility as the predicate devices." This implies that the current device's equivalence is established based on its similarity to a legally marketed predicate device that has already met certain performance standards through non-clinical testing (e.g., mechanical, material, biocompatibility tests), rather than a new standalone clinical study with specific acceptance criteria and performance metrics.
Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes, expert involvement, ground truth, MRMC studies, or standalone algorithm performance, and training set details, is not present in the provided document, as these typically relate to the evaluation of diagnostic or AI-powered devices, not primarily mechanical implants like intervertebral body fusion systems.
The document primarily focuses on establishing substantial equivalence based on design, materials, and intended use to an existing predicate device, backed by non-clinical (mechanical/material) testing.
§ 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.