Search Results

The NEXXT MATRIXX® SI System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.

· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients

undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The NEXXT MATRIXX® SI System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.

The NEXXT MATRIXX® SI System is a collection of additively manufactured implants intended to facilitate fusion of the sacroiliac joint. The NEXXT MATRIXX® SI System includes three different implants which are press-fit shafts or threaded screws including the IMPAXX SI Implant, HELIXX SI Fully Threaded Implant, and the HELIXX SI Lag Implant. The HELIXX SI Lag Implants may be used with optional HELIXX SI Modular Washers. All subject implants are manufactured from Ti-6A1-4V per ASTM F3001 or Ti-6A1-4V ELI titanium alloy per ASTM F136 and are offered in various sizes to accommodate patient anatomical needs.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (NEXXT MATRIXX® SI System), which is an orthopedic implant for sacroiliac joint fusion and fracture fixation.

This document describes the device, its intended use, technological characteristics, and references non-clinical performance testing. However, it does not contain information about studies related to AI/software performance, human reader studies (MRMC), or the evaluation of an algorithm against acceptance criteria for diagnostic or prognostic purposes.

Therefore, I cannot extract the information required to answer your questions regarding:

1. A table of acceptance criteria and the reported device performance (in the context of AI/software).
2. Sample sizes used for a test set or data provenance (related to AI/software performance).
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set (for AI).
9. How ground truth for the training set was established.

The document focuses on the mechanical and material performance of a physical implant and its substantial equivalence to predicate devices based on non-clinical (mechanical) testing, not on the performance of a software or AI component.

Ask a specific question about this device

The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-drilling versions. This submission adds additional 1-level plate options to the Struxxure Anterior Cervical Plate System.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "STRUXXURE® MCS Anterior Cervical Plate System." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical testing and a comparison of intended use, indications for use, basic design, and materials.

Crucially, this document does NOT describe the performance of software or an AI-powered device, nor does it detail a clinical study involving human readers or the establishment of ground truth for such a device. The acceptance criteria and study information requested in your prompt (related to AI/software performance) are not applicable to the content provided.

The document discusses:

• Device: STRUXXURE® MCS Anterior Cervical Plate System, which is an implantable medical device (plates and screws) for anterior cervical spinal fixation.
• Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device (STRUXXURE® Anterior Cervical Plate System) to allow the new device to be marketed.
• Testing: Mechanical tests were performed on the "worst case subject plate per ASTM F1717: static compression bending, static torsion, and dynamic compression bending."
• Conclusion: The tests demonstrated "substantially equivalent mechanical performance of the subject plates as compared to legally marketed predicates."

Therefore, I cannot provide the information requested in your prompt using the provided text because it does not pertain to the performance of a software or AI device. The document is about the physical characteristics and mechanical performance of a spinal implant.

Ask a specific question about this device

The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of rods, pedicle screws, connectors and fasteners. Rods are available in either straight, or pre-contoured (curved) or revision forms in a variety of lengths. Pedicle screws are available in modular and non-modular polyaxial, and non-modular uniplanar designs having double lead standard or cortical/cancellous thread forms in a variety of diameter-length combinations. Connectors include offset, various wedding band options and transverse rod-to-rod. Set screws are used to fasten the components. The INERTIA® CONNEXX™ Modular Pedicle Screw System implants may be sold sterile or nonsterile.

This document is a 510(k) Premarket Notification for a medical device called the "INERTIA® CONNEXX™ Modular Pedicle Screw System." It is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices.

Based on the provided text, the device in question is a pedicle screw system for spinal immobilization and stabilization, not an AI/software-driven diagnostic tool. Therefore, the information typically requested in questions 1-9 (related to acceptance criteria for AI algorithms, sample sizes for training/test sets, expert adjudication, MRMC studies, etc.) is not applicable to this type of device submission.

The "Performance Data" section explicitly states:

• "Mechanical testing of worst case INERTIA® CONNEXX™ constructs included dynamic compression bending according to ASTM F1717."
• "The results demonstrate that INERTIA® CONNEXX™ Modular Pedicle Screw System performance is substantially equivalent to the predicate."

This indicates that the acceptance criteria and proof of performance are based on mechanical testing of the physical device to ensure it meets established ASTM standards and is comparable to previously cleared devices, rather than on the performance of a diagnostic algorithm or human-AI interaction.

Therefore, I cannot provide answers to questions 1-9 regarding acceptance criteria and study details for an AI-driven device, as this document describes a physical spinal implant.

Ask a specific question about this device

The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (TI-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediative patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to treat adolescent idiopathic scolosis. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allografi. Pediatric pediatic pediatic pediatic pediatic pediatic pediatic pedicle screw fixation is limited to a posterior approach.

The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of longitudinal members (rods), anchors (pedicle screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The INERTIA® CONNEXX™ Modular Pedicle Screw System implants are sold sterile and non-sterile.

The provided text describes the 510(k) premarket notification for the INERTIA® CONNEXX™ Modular Pedicle Screw System. This document outlines the device's indications for use, description, and the performance data submitted to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text does not contain any information about a study proving that an AI/ML device meets acceptance criteria. The entire document pertains to a physical medical device (pedicle screw system) and focuses on mechanical testing for substantial equivalence, not on the performance of a software or AI/ML product.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets them based on the provided input. The input text is for a different type of medical device entirely.

Ask a specific question about this device

The NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The NEXXT SPINE NAVIGATION System is an instrumentation system which includes taps and a probe, an awl and an inserter. The devices are used in conjunction with the Medtronic® StealthStation Navigation System to assist with placement of the Nexxt Spine INERTIA® Systems (INERTIA® Pedicle Screw and INERTIA® Pedicle Screw and Deformity Correxxion System) pedicle screws. The instruments are sold non-sterile and are reusable.

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study, focusing on the requested categories:

Device Name: NEXXT SPINE NAVIGATION System

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the test set.

The provenance of the data is that it was generated through side-by-side testing of the NEXXT SPINE NAVIGATION System and the predicate device. The text does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide information on the number or qualifications of experts used to establish ground truth. The study appears to be a technical performance test rather than involving clinical experts for ground truth assessment.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The study outlined is a technical performance study comparing the device to a predicate, not a study evaluating human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was conducted. The "Navigation dimensional analysis and positional accuracy validations" were performed on the device itself, comparing its technical performance to a predicate device, without the involvement of human operators or a human-in-the-loop scenario.

7. Type of Ground Truth Used:

The ground truth for the performance tests appears to be established by technical measurements and standards as per ASTM F2554. This standard likely defines acceptable dimensional and positional accuracy, which served as the "ground truth" against which the device's performance was measured. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This is expected given that the device is an instrumentation system with navigation capabilities, not an AI or machine learning algorithm that typically requires a training set. The performance data focuses on inherent accuracy and dimensional properties.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

Ask a specific question about this device

The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels and should have received at least six months of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation). Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation.

NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone ALIF System includes additively manufactured interbody and traditionally machined fixation screw implants. The interbody and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the interbody 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 300-700µm pores. The inferior/superior aspects of the interbody incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with turn lock mechanisms which secure the screws to the interbody component.

The provided text describes the NEXXT MATRIXX® Stand Alone ALIF System, a medical device, and the basis for its 510(k) clearance by the FDA. However, the text details the substantial equivalence to a predicate device based primarily on mechanical performance testing, and does not describe acceptance criteria related to an AI/Machine Learning device or a study involving human readers or ground truth for AI model training.

Therefore, the following information cannot be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance (for AI/ML performance)
2. Sample size used for the test set and the data provenance (for AI/ML performance)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for AI/ML performance)
4. Adjudication method (for AI/ML performance)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size (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 (for AI/ML performance)
8. The sample size for the training set (for AI/ML training)
9. How the ground truth for the training set was established (for AI/ML training)

The document focuses on the mechanical performance testing of an intervertebral fusion device, not an AI/ML diagnostic or assistive device.

Here's the relevant information that is available regarding the device's performance testing, which is mechanical in nature:

1. Acceptance Criteria and Device Performance (Mechanical Testing)

The document states that the mechanical testing was performed according to ASTM F2267 and ASTM F2077. While specific numerical acceptance criteria are not explicitly detailed (e.g., "must withstand X N of compression"), the conclusion is that the device's performance is "substantially equivalent" to predicate devices. This implies that the device met the performance standards established by these ASTM norms and demonstrated comparable performance to already cleared devices.

2. Sample size used for the test set and the data provenance

The document mentions "worst case NEXXT MATRIXX® Stand Alone ALIF System devices" were mechanically tested. However, the exact sample size (e.g., number of devices tested for each mechanical test) is not specified. The data provenance is implied to be from laboratory testing as part of the device's development and regulatory submission.

3 - 7. Information related to AI/ML studies, expert ground truth, MRMC, or standalone AI performance

This information is not applicable as the document is for a physical orthopedic implant (intervertebral fusion device), not an Artificial Intelligence/Machine Learning (AI/ML) software or diagnostic device.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not an AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established

Not applicable, as this is a physical medical device, not an AI/ML model.

Ask a specific question about this device

The STRUXXURE®-L and STRUXXURE®-A Plate System is indicated for treatment of spine instability via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracolumbar (T1-L5) spine or via an anterior surgical approach below the bifurcation of the great vessels in the lumbar and lumbosacral (1-S1) spine. The indications for use include fracture (including dislocation and subluxation), turnor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, spondylolisthesis, pseudarthrosis and failed previous spine surgery.

The STRUXXURE®-L System may also be attached to NEXXT MATRIXX® Lateral interbody devices. The STRUXXURE®-A Plate System may also be attached to NEXXT MATRIXX® ALIF interbody devices. In these configurations the STRUXXURE®-L and STRUXXURE®-A Plate System is used to treat skeletally mature patients having DDD at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The STRUXXURE®-L and STRUXXURE®-A Plate System is a lumbar plate and screw system. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold non-sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "STRUXXURE®-L and STRUXXURE®-A Plate System." It confirms the device's substantial equivalence to legally marketed predicate devices based on its intended use and technological characteristics. However, the document does not contain the specific information requested about acceptance criteria for device performance, nor details of a study proving those criteria are met for AI/ML-based device performance.

The document focuses on the regulatory clearance process for a traditional, non-AI/ML spinal plate system, comparing its mechanical properties and design to a predicate device. It explicitly states:

• "Mechanical testing of the worst case STRUXXURE®-L and STRUXXURE®-A Plate System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. In addition, screw backout testing and cage-plate dissociation testing were performed. The mechanical test results demonstrate that the STRUXXURE®-L and STRUXXURE®-A Plate System performance is substantially equivalent."

This indicates that the "study" demonstrating performance is mechanical testing against an ASTM standard, rather than a clinical study evaluating diagnostic accuracy or a comparative effectiveness study involving human readers and AI.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of details are not present in the provided text for an AI/ML device.

Ask a specific question about this device

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.

Ask a specific question about this device

The NEXXT MATRIXX® Stand Alone Cervical-TL System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical-TL System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical-TL System is intended to be used with the bone screw fixation provided and requires no additional fixation.

NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone Cervical-TL System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7 µm). The intervening geometric lattices have 300-700um pores. The inferior/superior aspects of the spacer incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with a turn lock mechanism which secures the screw to the spacer component.

The provided text describes a 510(k) premarket notification for the NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System, a Class II intervertebral body fusion device. The submission focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and performance metrics for an AI/ML device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving device performance, as the document does not contain this information. The document pertains to a medical device clearance for an implant, not an AI/ML diagnostic or assistive technology.

Here's a breakdown of why the requested information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics in terms of sensitivity, specificity, accuracy, or other related metrics. It states, "The modified Stand Alone Cervical-TL device components were evaluated via dimensional analyses. The results demonstrated the performance of the modified Stand Alone Cervical-TL device is substantially equivalent to the predicate. In addition, the screw pushout properties for the modified Stand Alone Cervical-TL construct were evaluated." This refers to mechanical and physical properties of the implant, not diagnostic performance.

2. Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/ML system tested on a dataset.

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. "Ground truth" in the context of an AI/ML device (e.g., expert-labeled images) is not relevant for this physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This type of study is relevant for AI-assisted diagnostic tools, not for an intervertebral body fusion device.

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 (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a spinal implant, which confirms its substantial equivalence to a predicate device based on mechanical and material characteristics. It does not address AI/ML system performance or related study details.

Ask a specific question about this device

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.

Ask a specific question about this device