Search Results

When used as a pedicle screw fixation system, the NuVasive Reline 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The Nu Vasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the Nu Vasive Reline 4.5-5.0 System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Armada System.

The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce design changes to the modular screws of the previously cleared Reline 4.5-5.0 System.

The provided document is a 510(k) summary for the NuVasive® Reline® 4.5-5.0 System, a medical device for spinal fixation. It outlines the device's intended use, technological characteristics, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does not contain the level of detail requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device.

Specifically, the document discusses performance data in terms of nonclinical testing for mechanical properties, not performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, accuracy). It also does not involve human readers, ground truth establishment by experts, or training/test set sample sizes in the context of an AI/ML algorithm.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the document:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The "test set" in this context refers to physical device components undergoing mechanical testing, not a dataset for an AI/ML model. The document does not specify the number of samples tested for the Dynamic Flexion-Extension Moment Testing, nor does it refer to data provenance in the context of patient data.

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 / Not provided. This document describes a traditional medical device (spinal hardware) and its mechanical testing, not an AI/ML device that requires expert-established ground truth from medical imaging or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. Adjudication methods are relevant for establishing ground truth in human-AI studies or for resolving discrepancies in expert interpretations, which is not the subject of this document.

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 / Not provided. This document is for a spinal fixation system, not an AI-assisted diagnostic or interpretative device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. The device is a physical pedicle screw system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not provided. The "ground truth" for this device's performance is its mechanical integrity and strength as evaluated by a standardized test (ASTM F1798) to demonstrate substantial equivalence to a predicate device. There is no biological or interpretative ground truth in the AI/ML sense.

8. The sample size for the training set

• Not applicable / Not provided. This device does not involve a training set for an AI/ML model.

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

• Not applicable / Not provided. This device does not involve a training set for an AI/ML model.

In summary: The provided 510(k) summary is for a physical medical device (spinal fixation system) and details its mechanical performance testing to establish substantial equivalence. It does not provide information about acceptance criteria or a study design relevant to an AI/ML medical device as implied by the detailed questions.

Ask a specific question about this device

When used as a pedicle screw fixation system, the NuVasive® 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The NuVasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthosis 7. Tumor resection and/or 8. Failed previous fusion When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline 4.5-5.0 System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis, and fracture caused by turnor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Reline System.

The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a varietv screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) premarket notification for the NuVasive Reline 4.5-5.0 System, a pedicle screw system. It states that the device is substantially equivalent to legally marketed predicate devices. The information provided focuses on demonstrating this equivalence through non-clinical performance testing rather than clinical studies or AI-driven performance.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document confirms that "demonstrate that the subject NuVasive Reline 4.5-5.0 System is substantially equivalent to the predicate device." However, it does not provide specific numerical values for the acceptance criteria (e.g., minimum bending strength in Nm) or the numerical performance results of the NuVasive Reline 4.5-5.0 System or its predicate for direct comparison. It only states that the results show substantial equivalence.

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

The study described is non-clinical performance testing of a physical medical device (pedicle screw system), not an AI/software device involving data sets, patients, or human readers. Therefore:

• Sample Size for Test Set: This information is not provided as the tests are for mechanical properties of the device components. The ASTM standards typically specify the number of samples required for each test.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this involves mechanical testing of physical implants, not patient data.

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

Not applicable. Ground truth, in the context of expert consensus, is relevant for AI/diagnostic devices interpreting medical images or patient data. This is a physical device subject to mechanical engineering standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are used to resolve disagreements among human experts in clinical studies, not for non-clinical mechanical testing.

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

No, an MRMC comparative effectiveness study was not done. This document describes the testing of a physical medical implant (pedicle screw system), not an AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This document focuses on the mechanical properties and substantial equivalence of a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this type of device is defined by the ASTM standards (ASTM F1717 and ASTM F1798) themselves, which specify the test methodologies and, implicitly, the expected performance characteristics for pedicle screw systems. Substantial equivalence is determined by comparing the new device's performance to that of a legally marketed predicate device under these standardized test conditions.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device.

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

Not applicable. As there's no training set, there's no ground truth for it to be established.

Ask a specific question about this device