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When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment 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. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® ALIF and Lateral devices incorporate a large vertical cavity which can be packed with bone graft material. The devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

This appears to be an FDA 510(k) summary for a medical device called the "NEXXT MATRIXX® System," which is an intervertebral body fusion device. The document describes the device, its intended use, and the basis for its substantial equivalence to previously marketed devices.

However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm. The "Performance Data" section indicates: "The modified devices were evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF and Lateral interbody devices to substantially equivalent to the predicate." This refers to physical and mechanical characteristics of the implant, not the performance of an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI device meets those criteria based on this document. The document pertains to a physical medical device (spinal implant), not an AI algorithm.

If you have a different document or would like to ask about other aspects of AI device approval, please provide the relevant information.

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The NEXXT MATRIXX® corpectomy devices are indicated for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature patients to replace a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® corpectomy devices are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The NEXXT MATRIXX® corpectomy devices are intended for use with autograft or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft, as an adjunct to fusion and with FDA-cleared supplemental internal fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

This looks like a 510(k) summary for a medical device called the NEXXT MATRIXX® System, specifically for its corpectomy devices. Unfortunately, the provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI or algorithm performance.

The "Performance Data" section explicitly states: "The modified corpectomy device was evaluated via mechanical testing including included static and dynamic compression and static and dynamic torsion (ASTM F2077), subsidence (ASTM F2267) and expulsion. The results demonstrated the performance of the modified corpectomy is substantially equivalent to the predicate."

This describes physical and mechanical performance testing of the device itself (an implant used in spinal surgery), not the performance of an AI or algorithm. Therefore, I cannot extract the information requested regarding:

1. A table of acceptance criteria and reported device performance (for AI/algorithm)
2. Sample size and data provenance for a test set (for AI/algorithm)
3. Number and qualifications of experts for ground truth (for AI/algorithm)
4. Adjudication method (for AI/algorithm)
5. MRMC comparative effectiveness study (for AI/algorithm)
6. Standalone performance (for AI/algorithm)
7. Type of ground truth used (for AI/algorithm)
8. Sample size for the training set (for AI/algorithm)
9. How ground truth for the training set was established (for AI/algorithm)

The document is about the physical testing and substantial equivalence of a spinal implant device.

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When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment 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. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

This document (K193370) is a 510(k) premarket notification for a medical device called the "Nexxt Matrixx® System," specifically adding an anterior lumbar interbody fusion (ALIF) device. It is not a K medical device submission for an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be extracted from this document because it is not relevant to this type of traditional medical device submission.

The "Performance Data" section in the document states:

"The modified ALIF device was evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF is substantially equivalent to the predicate."

This indicates that the performance evaluation for this traditional device involved dimensional analyses to demonstrate substantial equivalence to a predicate device, not the kinds of clinical performance studies typically required for AI/ML devices.

Therefore, for your specific request:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of AI/ML performance. The success criterion here is "substantially equivalent" based on dimensional analyses.
2. Sample sized used for the test set and the data provenance: Not applicable. Dimensional analyses would involve measuring the device itself, not a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no "ground truth" in the AI/ML sense for a physical implant's dimensional analysis.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for a physical device's characteristics would be its specifications and physical measurements.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment 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. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

The NEXXT MATRIXX® rTLIF is a collection of additively manufactured spacers for lumbar/lumbosacral implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with autograft or allograft comprised of cancellous and/or corticocancellous bone graft material. The devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text is a 510(k) summary for a medical device (Nexxt Matrixx® System) and does not describe a study involving an AI or software-based medical device. Therefore, I cannot extract the information required to answer your prompt.

The document discusses a physical interbody fusion device and its substantial equivalence to a predicate device based primarily on mechanical performance testing (finite element analyses and Dynamic Axial Compression per ASTM F2077). It does not mention any artificial intelligence (AI) or machine learning components, nor does it describe a study involving human readers or the establishment of ground truth for a test set in the context of an AI device.

Therefore, I cannot populate the requested information.

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