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The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The PROVIDENCE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The VIP® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The XTEND® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The UNIFY® Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The CITADEL® Anterior Lumbar Plate System is intended for use by an anterior or anterolateral approach in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudarthrosis, spondylolisthesis, scoliosis, kyphosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

The TRUSS® Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or failed previous spine surgery.

The PLYMOUTH® Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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), and/or tumor. The SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for standalone use.

The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord.

These plate and screw systems are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, vertebrectomy, or laminectomy and may be inserted using an anterior, posterior, anterolateral, or lateral approach. The devices are available in various lengths and widths to accommodate varying patient anatomy. The plates are secured through the plate's screw holes into the vertebral bodies or a ratchet design which automatically locks during compression on the spinous process. Some devices can be used in conjunction with autograft and/or allogenic bone graft to be packed inside the device. These devices are manufactured from titanium alloy, or radiolucent PEEK polymer with titanium alloy or tantalum markers.

The provided text is a 510(k) summary for the MRI compatibility update and addition of sterile components for a range of spinal plate systems. It does not present acceptance criteria or detailed study results in the typical format of a clinical or performance study summary. Instead, it refers to standard ASTM tests conducted to determine MRI compatibility and confirms that no further performance or biocompatibility testing was required for this specific submission because the core device performance and technological characteristics remain unchanged from previously cleared versions.

Here's a breakdown of the information that can be extracted, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific acceptance criteria or quantitative performance results. It states that MRI testing was performed according to specific ASTM standards (F2052, F2119, F2182, F2213). For such MRI compatibility tests, the "acceptance criteria" usually refer to the device meeting the requirements outlined within those ASTM standards to be labeled as MR Conditional at a certain field strength. The document implies compliance without listing the specific numerical outcomes or acceptance thresholds used.

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

• Sample Size: The document states "MRI testing was performed on the worst case subject devices." It does not specify the exact number of devices tested for each ASTM standard.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was likely conducted in a controlled laboratory setting by Globus Medical or a contracted test facility. The nature of MRI compatibility testing for medical devices is typically in-vitro (lab-based) rather than using patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

• Not applicable. This submission is for MRI compatibility and sterile components, not for a diagnostic or AI device that requires expert-established ground truth from clinical cases.

4. Adjudication Method:

• Not applicable. This is not a study involving human readers or expert consensus for ground truth.

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

• No. This type of study is not relevant to a submission for MRI compatibility of spinal implants.

6. Standalone Performance Study:

• Yes (for specific performance aspects implied by conformity to ASTM standards). The MRI compatibility tests are "standalone" in the sense that they assess the device's characteristics in a controlled environment as per the ASTM standards. However, it's not a standalone clinical performance study in the context of an AI algorithm performing a task. The document states "No further device performance testing was required for this submission. The performance testing remains the same for the subject and predicate devices." This implies that the fundamental mechanical/structural performance of the spinal implants was established in prior submissions (e.g., K040721 for ASSURE® and other predicates listed in {12}).

7. Type of Ground Truth Used:

• Not applicable in the conventional sense of a clinical ground truth. For MRI compatibility testing, the "ground truth" is adherence to the physical and safety parameters defined by the ASTM standards (e.g., a certain displacement force is considered safe, a certain artifact size is acceptable).

8. 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" or a ground truth established for it.

In summary, the document details a regulatory submission to update labeling for MRI compatibility and add sterile components. It relies on established ASTM standards for MRI safety assessment, rather than a clinical performance study with patient data and expert ground truth.

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The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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), and/or tumor. The SP-Fix® spinous process fixation plate is intended for use with bone graft material and is not intended for stand-alone use.

The SP-Fix® Spinous Process Fixation Plate System consists of plates, rods, and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix® implants are composed of titanium allov (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).

Here's an analysis of the provided 510(k) summary for the Globus Medical Inc. SP-Fix® Spinous Process Fixation Plate, specifically addressing the requested information about acceptance criteria and the supporting study:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report or a comprehensive technical specification. Therefore, much of the requested information (like specific acceptance criteria values, detailed study designs, and ground truth establishment for AI systems) is not present in this type of document, as it's not typically required for a 510(k) for this type of device (a spinal fixation plate). This submission relies on engineering rationale and mechanical testing, not a clinical effectiveness study with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented (mechanical testing) supports this determination by showing that the new device's mechanical properties are comparable or superior to the predicate. Specific quantifiable thresholds for "static plate dissociation" are not typically disclosed in a public 510(k) summary, as they are part of the detailed testing protocol submitted to the FDA.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a spinal implant. The "test set" here refers to the samples used in mechanical testing, not a clinical dataset for an AI or human reader study. The number of physical units tested for "static plate dissociation" is not specified in this summary.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable. The data is from laboratory mechanical testing, not human patient data.

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

• Not applicable. This submission is for a medical device (spinal fixation plate) and relies on mechanical testing and engineering rationale, not expert clinical review (e.g., radiologist consensus) to establish ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This relates to clinical studies with human observers or AI outputs, which is not the basis of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. An MRMC study was not done. This device is a physical implant, not an AI diagnostic tool.

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

• No. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Testing Measurements: The "ground truth" for this device's performance is established through physical measurements and destructive testing in a laboratory setting (e.g., force required for static plate dissociation). This is compared against the known performance characteristics of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This refers to machine learning algorithms. The device does not involve a "training set."

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

• Not applicable. The device does not involve a "training set" or AI.

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The SP-Fix™ Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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), and/or tumor. The SP-Fix™ Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.

The SP-Fix™ Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix™ implants are composed of titanium alloy (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).

The provided text is for a 510(k) summary for the SP-Fix™ Spinous Process Fixation Plate, a medical device. It does not describe or include an AI device or a study involving AI. Therefore, I cannot provide information regarding acceptance criteria and studies that prove an AI device meets acceptance criteria.

The information provided pertains to the mechanical testing of a physical medical device to demonstrate its substantial equivalence to predicate devices, which is a standard regulatory pathway for non-AI medical devices.

Here's what I can extract from the provided text about the device and its testing:

Regarding the specific questions about AI device studies:

Since this document describes a physical medical device and its mechanical testing for regulatory clearance, the following points are not applicable and cannot be answered based on the provided text:

• Sample size used for the test set and the data provenance: Not relevant for mechanical testing of a physical device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for mechanical testing.
• Adjudication method for the test set: Not relevant for mechanical testing.
• 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 relevant for a physical medical device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for mechanical testing. The "ground truth" for mechanical testing is typically engineering specifications and performance benchmarks derived from predicate devices or industry standards.
• The sample size for the training set: Not relevant as there is no AI model being trained.
• How the ground truth for the training set was established: Not relevant as there is no AI model being trained.

The document states that mechanical testing was performed to demonstrate substantial equivalence. This type of testing involves subjecting the device to various physical forces and measuring its response, not analyzing data with an AI algorithm.

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