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The Avenue® L Lateral Lumbar 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

The ROI-A® ALIF Cage System is indicated for intervertebral body fusion of the from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

The ROI-T® Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

When used as a vertebral body replacement device, the ROI-T® Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.

The Avenue L Lateral Lumbar Cage is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA " LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L Lateral Lumbar Cage is available with VerteBRIDGE® titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, which may be used in addition to supplemental fixation. The Avenue L Lateral Lumbar Cage is designed for placement using a lateral surgical approach.

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 TLIF Cage System is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T TLIF Cage System 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 TLIF Cage System 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 TLIF Cage System via an integral locking pin.

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

The ROI-A ALIF Cage System is intended for use as an interbody fusion device in the lumbar spine. The device is manufactured from medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F560 embedded in the implant to facilitate visibility in x-ray imaging. The subject device is designed for placement using either an anterior or anterolateral approach. The ROI-A ALIF Cage System implants feature two slots which allow for use with device-specific integrated fixation - the ROI-A VerteBRIDGE anchoring plate. The ROI-A ALIF Cage System VerteBRIDGE anchoring plate is made of titanium alloy (Ti-6Al-4V, ASTM F136) and can be inserted to obtain fixation to the vertebral bone and create a standalone lumbar interbody fusion cage construct.

The ROI-T Implant System consists of crescent shaped cages in a variety of heights and lordotic angles. The ROI-T Implant System implant has an enclosed graft space design. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The ROI-T Implant System PEEK cages are designed to be inserted via a transforaminal approach. The ROI-T Implant System cages are manufactured from medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers (ASTM F560) embedded in the implant to facilitate visibility during x-ray imaging.

The provided document is a 510(k) premarket notification from the FDA regarding several intervertebral body fusion devices. It does not describe a study to prove a device meets acceptance criteria, but rather a submission for expanding indications for use of existing devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that a "comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modification for this device and that the devices was substantially equivalent to the predicate devices." This implies that the acceptance criteria revolved around demonstrating substantial equivalence and lack of additional risks when using allograft, rather than specific performance metrics against a predefined threshold. No specific performance data is reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or associated sample size is mentioned. The assessment was based on a "clinical literature review," not a specific study in this submission. Therefore, data provenance is not applicable in the context of a new study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. There was no test set or ground truth established by experts in the context of this submission. The determination was made through a literature review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not a study involving AI or human readers, but rather a regulatory submission for medical implants.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not directly applicable in the terms of a new study. The "ground truth" for the expanded indication was established through "comprehensive clinical literature review" demonstrating "substantial equivalence" and "no additional risks" compared to predicate devices. This relies on existing medical knowledge and regulatory precedent rather than a newly established ground truth for a test set.

8. The sample size for the training set:
Not applicable. This submission does not involve a training set for an algorithm.

9. How the ground truth for the training set was established:
Not applicable. This submission does not involve a training set for an algorithm.

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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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