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The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic. Jumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the following instabilities or deformities:

• Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

• • Spinal Stenosis (indicated for L1-S1 only);
• • Spondylolisthesis;
• • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• • Trauma (i.e., fracture, dislocation, or subluxation);
• • Spondylolysis;
• • Tumor;
• • Pseudoarthrosis: and/or
• • Failed previous fusion

The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.

The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laninoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following:

• • Pseudoarthrosis and failed previous fusions;
• • Spondylolisthesis;
• • Spondylolysis;

• Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;

• • Degeneration of the facets with instability and;
• • Trauma including spinal fractures and/or dislocations.

The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.

The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/illum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, 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; deformities or curvatures (i.e., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Alpine XC Adjustable MIS Fusion System 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 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); trauma (i.e., fracture or dislocation); and/or tumor. The Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use.

The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to 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 Aspendevice is intended for use with bone graft material, not intended for stand-alone use.

The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to 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 LPlate device is intended for use with bone graft material, not intended for stand-alone use.

The Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems referred to in this submission include the following systems: Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate. These subject Miscellaneous Spinal Fixation Systems are identical to the predicate Miscellaneous Spinal Fixation Systems, Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate, currently marketed. As defined within the product-specific Indications for Use, the subject Miscellaneous Spinal Fixation Systems are intended for the stabilization and immobilization of spinal segments as an adjunct to fusion in the cervical, thoracic, lumbar and/or sacral spine.

The provided text is a 510(k) summary for several Zimmer Biomet Spine fixation systems. It explicitly states that "Performance testing is not necessary" for this particular submission because the systems themselves are identical to already marketed predicate devices. The purpose of this submission is solely to obtain clearance for modified product labeling establishing the safety and compatibility of these existing passive implants in the magnetic resonance (MR) environment.

Therefore, the document does not contain information about acceptance criteria or a study demonstrating device performance in the traditional sense of evaluating efficacy or accuracy against a pre-defined standard. It's a regulatory filing based on demonstrating substantial equivalence to already cleared devices.

Based on the provided text, I can extract the following information:

1. Table of acceptance criteria and the reported device performance: This information is not present in the document. The document states "Performance testing is not necessary to evaluate the effects within magnetic fields during Magnetic Resonance Imaging (MRI) on the subject Miscellaneous Spinal Fixation Systems." The submission is for modified labeling regarding MRI safety of existing devices, which are substantially equivalent to their predicates.

2. Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication was involved.

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 document is about spinal fixation systems, not AI-powered medical imaging devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about spinal fixation systems, not standalone algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for performance testing.

8. The sample size for the training set: Not applicable. This document is about physical medical devices, not machine learning models with training sets.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth was established.

In summary, the provided FDA 510(k) summary (K202309) primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for the purpose of clarifying MRI safety labeling. It explicitly states that performance testing is not necessary because the devices themselves are identical to their predicates, and the changes are limited to labeling regarding MRI compatibility. Therefore, the details requested about acceptance criteria, study design, and performance metrics are not present in this specific document.

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The Gallery™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery™ Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Gallery™ Laminoplasty Fixation System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure.

The provided document describes the "Gallery™ Laminoplasty Fixation System," a medical device intended for spinal fixation. It outlines the device's indications for use and a summary of mechanical testing conducted to establish substantial equivalence to predicate devices.

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 a distinct "test set" in the context of a clinical study or AI model evaluation. The "performance data" refers to mechanical testing of the device itself.

• Sample Size: Not explicitly stated as a number of devices or iterations, but implied to be sufficient for mechanical testing according to the listed ASTM standards and worst-case construct testing.
• Data Provenance: The data is from mechanical testing performed on the device itself (Gallery™ Laminoplasty Fixation System) rather than human or animal subjects. No country of origin is mentioned for the data, as it is laboratory-based mechanical testing. The testing is assumed to be prospective to the submission date.

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

N/A. This information is not relevant as the study described is mechanical testing of a medical device, not a human reader or AI study where ground truth would be established by experts.

4. Adjudication Method for the Test Set:

N/A. This is not applicable to the mechanical testing described.

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 MRMC comparative effectiveness study was mentioned. The document describes mechanical testing of a spinal fixation system, not an AI or human-reader study.

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

No standalone algorithm performance study was mentioned. The device is a physical implantable system, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" here refers to the established standards and specifications for material properties and mechanical performance of spinal fixation devices. These are implicitly defined by the ASTM standards (ASTM F382-99, ASTM F543-07) and engineering rationale for worst-case construct testing.

8. The Sample Size for the Training Set:

N/A. This device is a physical medical implant, not an AI system that requires a "training set."

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

N/A. This question is not applicable to the device described.

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