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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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FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

FORTIFY® Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The spacers include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and the endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft comprised of cancellous or corticocancellous bone graft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surface grips the endplate of the adjacent vertebrae to resist expulsion. FORTIFY® Variable Angle endplates provide adjustable lordosis/kyphosis.

The provided text is a 510(k) summary for a medical device called "FORTIFY® Corpectomy Spacers." This document is focused on demonstrating the substantial equivalence of a new version of the device (with variable angle endplates) to previously cleared predicate devices.

It's crucial to understand that a 510(k) submission for a spinal implant device like this is primarily based on demonstrating mechanical and material equivalence to a predicate device, not on clinical performance metrics or AI algorithm validation. The questions you've asked (about acceptance criteria, AI performance studies, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices, especially those involved in image analysis or diagnostic support.

Therefore, based on the provided text, I cannot answer your specific questions related to AI/ML device validation. The information provided by the FDA for this particular 510(k) focuses on the mechanical and material aspects of the physical implant.

Here's a breakdown of why your specific questions cannot be answered from this document:

• No AI Component: The device described, FORTIFY® Corpectomy Spacers, is a physical spinal implant. It does not appear to involve any AI/ML components for image analysis, diagnosis, or treatment planning.
• Performance Data Type: The "Performance Data" section explicitly states: "Mechanical testing (static and dynamic compression, static and dynamic torsion, and expulsion) was conducted in accordance with ASTM F2077 and 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011." This confirms the performance data is related to the physical properties and biocompatibility of the implant, not to the performance of an AI algorithm.
• Focus on Substantial Equivalence: The entire submission's purpose is to show "substantial equivalence" to existing physical devices, meaning it works similarly, has similar indications, and performs mechanically as well as the predicate. This is a common pathway for new versions of existing medical devices and does not typically involve clinical trials or AI validation studies.

In summary, the provided document is for a traditional physical medical device and therefore does not contain the information requested about AI acceptance criteria and validation studies.

If you have a document describing an AI/ML medical device, please provide that, and I would be able to address your questions.

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