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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)

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The LumiVyTM 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.

Additional supplemental fixation is not necessary for the LumiVy™ - AS implants if the integrated screws are implanted.

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™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body.

The FDA submission for the LumiVy™ Lumbar IBF System does not contain information regarding acceptance criteria for device performance based on a study, or details of such a study. The document is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, primarily based on material, intended use, and design characteristics.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance.
• Sample size, data provenance, or details about ground truth establishment or experts for a performance study.
• Information on adjudication methods.
• Details on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set sample size or ground truth establishment for a training set.

The document states: "No additional testing was performed on the LumiVy™ Ti Lumbar IBF components." This indicates that a separate performance study with associated acceptance criteria for the device itself was not conducted for this specific 510(k) submission. Substantial equivalence was demonstrated through comparison to existing cleared predicate devices.

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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.

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