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The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis.
10. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.

The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

3° Anterior Cervical Plating System - The 3° Anterior Cervical Plating System is a temporary titanium alloy (Ti6Al-4V ELI, per ASTM F136) system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assists in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.

Reliant Anterior Cervical Plating System - The Reliant Anterior Cervical Plating System is temporary, titanium alloy system comprised of a variety of single-use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assist in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.

Unity Lumbosacral Fixation System - The Unity Lumbosacral Fixation System consists of the Unity 51 Lumbosacral Fixation Plate for lumbosacral fixation and the Unity LX Lumbar Fixation Plate for anterior or anterolateral fixation above L5-S1.

The Unity 51 Lumbosacral Fixation Plate is designed specifically for supplemental fixation of anterior lumbar fusions at the L5-S1 level. The plate is contoured to the unique anatomy of the L5-S1 segment. The Unity 51 Plate is available in six heights: 17mm to 25mm in 2mm increments and one additional plate at 28mm.

The Unity LX Lumbar Fixation Plate is designed for lumbar levels above L5-S1 in 2 configurations - anterior and anterolateral. In the anterolateral configuration, the plate allows surgeons lateral-to-medial placement of the self-neuro foramen. The Unity LX Plate is available in six heights: 19mm to 25mm in 2mm increments and two additional plates at 28mm and 31mm.

Hallmark Anterior Plate System – The Hallmark Anterior Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V-ELI, per ASTM F136) components that allow a surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

NewBridge Laminoplasty Fixation System – The NewBridge Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium alloy components. The specially shaped plates, made of commercially pure (CP) titanium conforming to ASTM F67, are designed to fit the anatomy of a dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.

The screws, made of titanium alloy (Ti-6AI-4V ELI, per ASTM F136) are available in a variety of lengths and diameters in order to meet individual anatomical requirements.

The NewBridge Laminoplasty Fixation System must always be used with an allograft.

CETRA Anterior Cervical Plate System – The CETRA Anterior Cervical Plate System is comprised of an assortment of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body, by means of screws to the cervical spine. The system includes the necessary instrumentation to assist in the surgical implantation of the devices.

The provided document describes the addition of MR Conditional labeling to several spinal fixation systems and details the non-clinical tests performed to support this claim. It does not contain information about a study proving the device meets clinical acceptance criteria or comparative effectiveness with human readers. The information below is based only on the provided text, focusing on the MR Conditional aspect.

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria for MR Conditional labeling:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Conditional Labeling)

Note: The document states that the devices "met requirements necessary for MRI Conditional labeling", implying that the performance in each test fell within the acceptable limits defined by the respective ASTM standards for MR Conditional compatibility. Specific quantitative values for displacement force, torque, artifact size, or temperature rise are not provided in this summary.

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

• Sample Size: Not explicitly stated for each test. The testing was conducted on the "subject devices," referring to the various components of the 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, and CETRA Anterior Cervical Plate System. Typically, MR safety testing involves multiple samples of the actual devices or representative worst-case configurations.
• Data Provenance: The tests conducted are non-clinical, controlled laboratory experiments. No human patient data (retrospective or prospective) or country of origin for such data is relevant for these specific MR safety tests.

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

• Not applicable. The ground truth for MR Conditional testing is established by recognized international standards (ASTM). The tests are performed by qualified testing laboratories or personnel following these standardized protocols, not by clinical experts establishing a ground truth based on patient cases.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical study endpoints, especially when expert consensus is needed to establish ground truth or resolve discrepancies in interpretations of medical images or patient outcomes. For non-clinical, standardized engineering tests, the results are objectively measured against the criteria defined in the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for the addition of MR Conditional labeling, which relies on non-clinical engineering tests to ensure device safety in the MR environment. It does not involve AI or human-in-the-loop performance evaluation.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone study in the context of an algorithm or AI performance was not done. The tests performed are engineering-based evaluations of physical device properties in an MR environment.

7. The Type of Ground Truth Used

• The ground truth used for this determination is explicit, objective criteria defined by internationally recognized consensus standards for MR safety: ASTM F2052-15, ASTM F2213-17, ASTM F2119-07, ASTM F2182-19E2, and ASTM F2503. These standards specify the methods and acceptable limits for magnetically induced displacement, torque, image artifacts, and radiofrequency induced heating.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device. Therefore, there is no "training set" in the conventional sense.

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

• Not applicable. Since there is no training set, the establishment of its ground truth is not relevant.

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The AZURE Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

• a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
• b) Spondylolisthesis;
• c) Trauma (i.e., fracture or dislocation);
• d) Spinal stenosis;
• e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• f) Tumor;
• g) Pseudoarthrosis;
• h) Revision of previous surgery

The AZURE Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) and Nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.

The provided text describes the AZURE Anterior Cervical Plate System, a medical device, and its premarket notification. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices tested) for the mechanical tests. The data provenance is non-clinical, meaning it's from laboratory testing of the device itself, not from human or animal subjects. The testing was conducted in a laboratory setting to ASTM F1717-12 standards.

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

This question is not applicable in this context. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by expert medical consensus. The performance is objectively measured against the criteria defined by ASTM F1717-12.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical mechanical testing. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth for clinical data. Here, performance is determined by objective measurements meeting predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic or assistive AI system on human reader performance for interpretation of medical images or data. The AZURE Anterior Cervical Plate System is a physical implant, not a diagnostic or AI-driven system.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. Again, this device is a physical implant, not an algorithm. The performance evaluation is based on its mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance study (mechanical testing) is the established engineering specifications and performance thresholds defined within the ASTM F1717-12 standard. The device's ability to withstand static torsion, static axial compression bending, and dynamic axial compression bending according to this standard is the objective measure of its performance.

8. The Sample Size for the Training Set

This is not applicable. Training sets are used in the development of AI algorithms. This document is for a physical medical device (an anterior cervical plate system), not an AI algorithm.

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

This is not applicable, as there is no training set for a physical implant.

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The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:

• instability caused by trauma or fracture; .
• instability associated with correction of cervical lordosis and kyphosis deformity; ●
• . instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic . malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative . · disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.

1. Acceptance Criteria and Reported Device Performance:

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

The provided document describes mechanical and other non-clinical performance testing. It does not mention a "test set" in the context of clinical data, human subjects, or data provenance from specific regions. The testing was conducted on samples of the Reliance Anterior Cervical Plate System itself.

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. This was a non-clinical performance study involving mechanical testing and assessments of material properties, not a study requiring expert clinical review to establish ground truth.

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

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth. This document describes non-clinical performance 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:

Not applicable. This device is a spinal implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

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

Not applicable. This device is a physical medical implant, not a software algorithm.

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

The "ground truth" for this performance study was established through standardized mechanical testing protocols (ASTM F-1717) and assessments of material properties (sterilization, biocompatibility). The comparison was made against the performance of legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This document describes non-clinical performance testing of a physical device, not a machine learning model that requires a training set.

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

Not applicable, as no training set for a machine learning model was used.

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