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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 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 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 allograft or autograft bone and is not intended for stand-alone 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 allograft or autograft bone in place in order to prevent the graft from expulsion, or impinging the spinal cord.

SP-Fix®: 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.

RELIEVE®: The RELIEVE® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. RELIEVE® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Plates may be filled with bone graft material. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

The provided document is a 510(k) premarket notification from the FDA for two medical devices: the SP-Fix® Spinous Process Fixation Plate and the RELIEVE® Laminoplasty Fixation System. It confirms that the FDA has reviewed the submission and determined that the devices are substantially equivalent to legally marketed predicate devices.

However, this document does NOT contain information related to the acceptance criteria and the study that proves a device meets given acceptance criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, expert involvement for ground truth, adjudication methods, or MRMC studies for a test set.
• Information on standalone algorithm performance.
• Type of ground truth used.
• Sample size for and establishment of ground truth for a training set.

The document states under "Performance Data":

"Globus is not aware of any performance standards or special control as established to date for the above device or product code. Testing was conducted in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Static and Dynamic Compression and Static Cantilever Bending testing performed on the RELIEVE® plates demonstrates substantial equivalence to the predicate devices. No additional mechanical testing for SP-Fix® plates was performed."

This indicates that mechanical testing was performed to demonstrate substantial equivalence to predicate devices, rather than to meet specific performance acceptance criteria for a new, AI-based device. The context of your request (acceptance criteria, test/training sets, ground truth, experts, MRMC, etc.) strongly suggests an AI/ML medical device, which is not what this FDA submission describes.

Therefore, I cannot fulfill your request using the provided text because the document does not discuss the kind of performance studies (e.g., involving AI/ML, human readers, or specific diagnostic accuracy metrics) that your detailed questions pertain to.

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The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).

The provided document is a 510(k) premarket notification for the Choice Spine Laminoplasty™ Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a diagnostic or AI-driven device.

Instead, for a medical device like a spinal fixation system, "acceptance criteria" are generally met through a combination of:

• Design Specifications and Material Compliance: Ensuring the device is manufactured from medical-grade materials to specific dimensions and tolerances.
• Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
• Mechanical Performance Testing: Evaluating the device's strength, durability, and resistance to various forces it might experience in vivo.
• Sterilization Validation: Ensuring the device can be sterilized effectively without compromising its integrity.
• Clinical Performance (often through substantial equivalence): Demonstrating that the device performs as intended and is as safe and effective as legally marketed predicate devices.

The document primarily focuses on the Substantial Equivalence claim, which is the cornerstone for 510(k) clearance.

Here's an analysis based on the provided text, addressing your points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are derived from recognized standards and comparative performance to predicates, rather than a specific set of diagnostic metrics.

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

For a spinal fixation system seeking 510(k) clearance, the "test set" primarily refers to the physical devices (prototypes or production samples) subjected to mechanical and material testing, not a dataset of patient images or outcomes.

• Sample Size for Mechanical Testing: Not explicitly stated in the document. These tests (ASTM F2193, ASTM F543) typically require a specific number of samples (e.g., n=5 or n=6) to establish statistical significance for material properties and device performance.
• Data Provenance: The mechanical test data would be generated in a lab setting, typically by the manufacturer or a contract testing facility, specifically for this device design. It's not "retrospective or prospective" in the sense of clinical trials.

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

This concept is not applicable to this type of medical device submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms where subjective human interpretation is being evaluated or augmented. For a spinal implant, mechanical tests use objective physical measurements against established standards, and "ground truth" for clinical safety and effectiveness is largely inferred from substantial equivalence to devices with a known clinical history.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in clinical studies or when interpreting diagnostic images to resolve discrepancies among expert readers and establish a reference standard. For mechanical testing, the results are quantitative measures from instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted or is not detailed in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices or AI tools to assess reader performance with and without AI assistance. This device is a physical implant, not a diagnostic tool.

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

Not Applicable. This device is a physical spinal implant, not an algorithm or AI product. Its performance is evaluated through mechanical testing and comparison to predicate devices, not algorithm-only performance.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily established through:

• Recognized Standards: Specific ASTM standards (F2193, F543) define the methodologies and expected performance characteristics for spinal fixation devices. Compliance with these standards forms a "physical ground truth."
• Predicate Device Performance: The established safety and effectiveness of the identified predicate devices (DePuy Mountaineer, Synthes Arch Fixation System, Medtronic CENTERPIECE Plate Fixation System, Spectrum Spine Laminoplasty Plating System) serve as a de-facto "clinical ground truth" for substantial equivalence. The new device is accepted if it performs similarly or better in mechanical tests and has similar indications and materials.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware, not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable. As there is no training set for a hardware device, no ground truth needed to be established for it.

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

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

The HAVEN™ Laminoplasty System consists of spinal fixation plates for use in Laminoplasty. These implants are composed of titanium or titanium alloy (per ASTM F67, F136, F1295, and F1472). HAVEN™ implants may be used with previously cleared CANOPY®, RELIEVE®, QUARTEX™, ELLIPSE®, PROTEX CT® screws and CANOPY® Spacer.

The CANOPY® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY® plates and screws are manufactured from titanium or titanium alloy, as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent PEEK as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

This document describes the FDA's clearance of the HAVEN™ Laminoplasty System and CANOPY® Laminoplasty Fixation System. It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the requested information about acceptance criteria and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size) is largely not applicable in the context of this 510(k) submission.

Explanation:

• 510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is "substantially equivalent" to a device already on the market (a predicate device). This often relies on comparing technical characteristics, materials, and mechanical or non-clinical performance, rather than clinical efficacy against pre-defined acceptance criteria for patient outcomes.
• Mechanical Testing vs. Clinical Studies: The performance data section explicitly states, "Compression, cantilever bending and expulsion testing performed on the HAVEN™ plates demonstrates substantial equivalence to the predicate devices. No additional testing for CANOPY® plates was performed." This indicates that the primary basis for clearance was a comparison of mechanical properties, not clinical performance against specific metrics.
• Absence of Clinical Study Details: The document does not mention any clinical studies, patient data, ground truth establishment by experts, or statistical analyses of human reader performance (MRMC) or standalone algorithm performance that would be typical for AI/ML device clearances requiring such details.

However, based on the provided document, I can extract the following relevant information regarding performance and its basis for substantial equivalence:

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

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

• Not Applicable in the traditional sense for clinical data. The performance claims are based on mechanical testing of the devices themselves, not on a test set of patient data.
• Data Provenance: The mechanical testing was performed by the manufacturer, Globus Medical Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No expert-established ground truth for patient data is mentioned as part of this 510(k) clearance.

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

• Not Applicable. No adjudication method for expert review of patient data is mentioned.

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 is a physical medical device (spinal fixation system), not an AI/ML algorithm for image interpretation or diagnosis. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable for clinical ground truth. For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate device's established mechanical properties.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device relying on a training set of data.

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

• Not Applicable. As above, no training set for an algorithm is involved.

In summary: The provided document is a 510(k) clearance for a spinal implant system. The "study" referenced is mechanical performance testing to demonstrate substantial equivalence to predicate devices, not a clinical study involving patient data, expert review, or AI performance metrics.

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

The Xspan™ Laminoplasty Fixation System is a posterior implant system comprised of laminoplasty plates, hinge plates, and mounting screws. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system components are manufactured from Titanium based alloy in accordance with ASTM F136. The single use only implants are provided sterile [gamma radiation] and should not be reused under any circumstances.

The system also includes instrumentation to aid with implantation. The instruments are supplied in a tray which is used for instrument sterilization and storage.

The provided text is a 510(k) Summary for the Xspan™ Laminoplasty Fixation System, a medical device for spinal surgery. This document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study demonstrating the device meets specific acceptance criteria related to a diagnostic or AI algorithm's performance.

Therefore, many of the requested categories cannot be filled as they pertain to studies evaluating the performance of AI/diagnostic devices, which is not the subject of this 510(k) summary. I will answer based on the information available in the document, and indicate "Not Applicable" or "Not Provided" where the information is not present.

Acceptance Criteria and Study Summary for Xspan™ Laminoplasty Fixation System

This device is a surgical implant, not a diagnostic or AI-driven device. The "acceptance criteria" here refer to the performance benchmarks established through mechanical testing to demonstrate equivalence to predicate devices, rather than criteria for diagnostic accuracy (e.g., sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as "sample size" in the context of a clinical test set. For mechanical testing, the information on the number of devices or test specimens is not provided.
• Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data origin is from internal testing performed by X-spine Systems, Inc.

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

Not applicable. This device is a surgical implant, and the performance evaluations primarily involve mechanical testing and material conformance, not expert-adjudicated ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for establishing ground truth in diagnostic studies, not for mechanical performance testing of a spinal implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

Not applicable. This is a medical device (spinal implant), not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a medical device, not an AI algorithm.

7. Type of Ground Truth Used

• For Mechanical Testing: Engineering specifications and standardized test methods (ASTM F2193 and ASTM F382) served as the "ground truth" or benchmarks for performance. Comparison was made against established performance profiles of predicate devices.
• For Biocompatibility: Material standards (ASTM F136) and historical evidence of biocompatibility for the specified titanium alloy served as the "ground truth."

8. Sample Size for the Training Set

Not applicable. This device does not involve an AI algorithm that requires a training set.

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

Not applicable. This device does not involve an AI algorithm or a training set.

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

The Release Laminoplasty Fixation System consists of a variety of sizes of implantable plates and screws that are attached to the lamina after a laminoplasty or laminectomy procedure. The implantable components are manufactured from medical grade ASTM F 136 Titanium alloy. The system also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for a medical device called the "Release® Laminoplasty Fixation System." It includes information about the device's intended use, classification, and a summary of performance data. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI-powered device or diagnostic.

This document is a regulatory submission for a physical implantable device (plates and screws for spinal fixation), not an AI/ML-driven diagnostic or medical device. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment is not applicable to the content provided.

The "Non-Clinical Performance Data" section mentions:

• ASTM F543 (screw insertion torque, torque to failure, pull-out)
• ASTM F2193 cantilever bend testing
• Finite Element Analysis

These are standard mechanical and material performance tests for physical orthopedic implants, not software or AI-based diagnostics. The document explicitly states: "Clinical performance data was not provided in this submission for a determination of substantial equivalence." This further indicates that no clinical study (which would be relevant for establishing performance characteristics in the context of AI) was conducted or reported in this submission.

Therefore, I cannot fulfill the request as the provided text does not contain the pertinent information for an AI/ML device.

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

The CANOPY™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY™ plates and screws are manufactured from titanium or titanium allov. as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent polymer as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

The provided document is a 510(k) summary for a medical device called the CANOPY™ Laminoplasty Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.

However, the document does not contain information related to an AI/ML device study. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes, data provenance, or details about test sets and training sets for an AI/ML model.
• Information about experts, ground truth adjudication, or multi-reader multi-case studies related to an AI/ML model.
• Any mention of standalone algorithm performance or human-in-the-loop performance with AI assistance.

Instead, the performance data cited refers to "Mechanical testing (static and dynamic compression, static compression bending and expulsion) was conducted in accordance with ASTM F543 and F2193 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004." This indicates physical testing of the implant's mechanical properties, not an AI/ML diagnostic or prognostic study.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies related to an AI/ML device based on the provided text. The document describes a physical medical implant device, not an AI/ML software device.

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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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