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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 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 PLYMOUTH™ Thoracolumbar Plate System consists of rigid plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). These implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.

This document is a 510(k) summary for the PLYMOUTH™ Thoracolumbar Plate System. It describes the device, its indications for use, and the performance data submitted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that mechanical testing was conducted "in accordance with 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 to demonstrate substantial equivalence to the predicate system." It lists the types of tests: "static and dynamic compression bending and static torsion."

While the document indicates what tests were performed and which guidance document they followed, it does not explicitly state specific numerical acceptance criteria (e.g., minimum strength, maximum deformation) or the quantitative results of these tests for either the new device or the predicate. It only broadly asserts that the device is "similar to the predicate devices with respect to technical characteristics, design, materials, performance, and intended use" and that the information "supports substantial equivalence."

Therefore, a table with specific numbers for acceptance criteria and reported performance cannot be fully constructed from the provided text.

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

The document describes mechanical testing of the device itself, not clinical testing on human subjects. Therefore, the concepts of "test set" and "data provenance" (country of origin, retrospective/prospective) as they relate to human patient data are not applicable here. The "test set" refers to the physical devices tested in the lab. The sample size for these mechanical tests is not explicitly stated in the provided text.

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

This question is not applicable. Ground truth, in the context of expert consensus, typically refers to clinical data interpreted by medical professionals. This document focuses on mechanical performance of a medical device in a laboratory setting, not diagnostic or clinical accuracy determined by experts.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 refer to consensus processes among human reviewers of clinical data.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers evaluating medical cases (e.g., medical images) to compare the effectiveness of different diagnostic or interventional approaches, often with and without AI assistance. This 510(k) pertains to the mechanical performance of a spinal implant, not a diagnostic or AI-assisted interpretation tool.

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 510(k) is for a physical medical device (thoracolumbar plate system), not for an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation is established by engineering standards and predicate device performance. The mechanical tests (static and dynamic compression bending, static torsion) are designed to assess physical properties and durability against established industry guidance for spinal systems. The "truth" is whether the device meets these mechanical performance expectations and performs "similar" to legally marketed predicate devices.

8. The Sample Size for the Training Set:

This question is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) is for a physical medical device and does not involve an AI or machine learning component.

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

This question is not applicable for the same reasons as point 8.

In summary, the provided document details the mechanical testing of a spinal implant for 510(k) clearance, asserting substantial equivalence to predicate devices based on adherence to FDA guidance. It does not involve clinical studies with human subjects, expert consensus, or artificial intelligence/machine learning components that would necessitate the information requested in many of your questions.

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