(300 days)
The LumiVy™ Lumbar IBF System 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 LumiVy™ Lumbar IBF System 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 radios. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
Additional supplemental fixation is not necessary for the Lumi Vy™ -AS implants if the integrated screws are implanted for cages with a lordosis of less than or equal to 20°.
The purpose of this 510(k) submission is to introduce the LumiVy™ OsteoVy™ PEKK Lumbar IBF configuration. The LumiVy™ Lumbar IBF System device is intended to be used as an intervertebral body fusion device. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. These devices also contain Tantalum wires to aid in fluoroscopic visualization. The LumiVy™ Lumbar IBF System device is available in multiple anatomical shapes and sizes, to accommodate various vertebral bodies. These include smaller cylindrical and rectangular shapes, elongated elliptical shapes, and larger hemi-cylindrical shapes. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The LumiVy™ NanoVy™ Ti Lumbar IBF components are made of PEEK Optima LT1 with CP Titanium coating. The LumiVy™ OsteoVy™ PEKK Lumbar IBF is made from OXPEKK. The LumiVy™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body. Additionally, this submission adds hyper-lordotic options to the LumiVyTM System.
The provided text is a 510(k) summary for the LumiVy™ Lumbar IBF System, a medical device for spinal fusion. This document describes the device, its intended use, and substantial equivalence to predicate devices, primarily through non-clinical mechanical testing.
Crucially, there is no mention of an AI/ML component or associated clinical study for the device's performance or acceptance criteria related to AI/ML. The document focuses solely on the physical device itself (intervertebral body fusion system) and its mechanical performance.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving device performance related to an AI component, as the provided text does not contain any information about an AI/ML aspect of the LumiVy™ Lumbar IBF System.
The sections of your prompt that I cannot address based on this document include:
- A table of acceptance criteria and the reported device performance (for an AI component)
- Sample size used for the test set and data provenance (for an AI component)
- Number of experts used to establish ground truth and qualifications (for an AI component)
- Adjudication method (for an AI component)
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for an AI component)
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (for an AI component)
- The type of ground truth used (for an AI component)
- The sample size for the training set (for an AI component)
- How the ground truth for the training set was established (for an AI component)
§ 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.