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The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.

The provided text does not contain information regarding software or AI device performance, acceptance criteria, or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification summary for a medical device called the "Spine Wave Gen II Expandable Interbody System," which is a physical implant for intervertebral body fusion procedures.

The information provided covers:

• Device Name: Spine Wave Gen II Expandable Interbody System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at specific levels (L2-S1 posterior surgical approach, L2-L5 lateral surgical approach), used with autogenous bone graft and supplemental fixation, after at least six months of non-operative treatment.
• Device Description: Composed of titanium alloy, PEEK-OPTIMA with BaSO4, and commercially pure titanium wafers stacked into an expandable implant. Includes a delivery device and is provided sterile.
• Predicate Devices: Multiple predicate devices from Spine Wave, Globus Medical Inc., LDR Spine USA, Ulrich GmbH & Co. KG, Biomet Spine, and Synthes Spine Co. LP.
• Non-Clinical Performance Data: Lists various ASTM standards for testing coating microstructure, shear testing, shear fatigue testing, tensile testing, abrasion testing, static and dynamic axial compression, static and dynamic compression shear, subsidence, and wear debris analysis. These are mechanical and material property tests for the physical implant, not software.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving a device meets acceptance criteria related to a software or AI device, as that information is not present in the provided document.

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The Avenue® T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.

The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous bone graft for fusion.

After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral titanium locking pin.

The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.

The Avenue T cages are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.

The provided text describes a medical device (Avenue T® TLIF Cage) and its FDA clearance. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance, which is what your request is focused on. This document is a 510(k) summary for a physical medical implant, not an AI or software as a medical device.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars for AI-related performance. The document explicitly states:

• "Clinical testing was not required to demonstrate substantial equivalence." This means no human clinical trials were performed to assess patient outcomes or the device's clinical effectiveness in a real-world setting.
• "Non-clinical performance bench testing conducted to support substantial equivalence for the Avenue T TLIF Cage included: ... The results of this non-clinical testing demonstrate that the strength of the Avenue T TLIF Cage is sufficient for its intended use and is therefore substantially equivalent to legally marketed predicate devices." The "acceptance criteria" here refer to engineering and biomechanical tests comparing the device to existing predicate devices, not performance against clinical endpoints or AI metrics.

The information you are asking for, such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, and ground truth types, are standard for AI/software medical devices undergoing regulatory review, but are not applicable to the documentation provided for this physical implantable device.

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