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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 CITADEL™ Anterior Lumbar Plate System is intended for use 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), spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

The CITADEL™ Anterior Lumbar Plate System consists of plates of various lengths with variable or fixed bone screws for spinal fixation of the anterior or anterolateral vertebral bodies of the lumbar or lumbosacral spine (L1-S1). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

The provided text describes a medical device, the "CITADEL™ Anterior Lumbar Plate System," and its 510(k) submission to the FDA. The submission focuses on establishing substantial equivalence to predicate devices through mechanical testing. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device.

Here's an analysis based on the provided text:

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

• Not found: The document states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 3, 2004 is presented." However, it does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the explicit performance results of the CITADEL™ device against these criteria. It only asserts that the device is "similar" to predicate devices in "technical characteristics, performance, and intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not found: This device is a mechanical orthopedic implant, not an AI or algorithm-based diagnostic tool. Therefore, concepts like a "test set" with data provenance (country, retrospective/prospective) are not relevant in the context of the device described here. Mechanical testing typically uses physical samples of the device components. The document does not specify the number of samples used for the mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable: Ground truth using expert consensus is relevant for diagnostic performance studies, not for the mechanical testing of an implant.

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

• Not applicable: Adjudication methods are relevant for expert review in diagnostic studies, not for mechanical testing.

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 mechanical implant, not an AI-assisted diagnostic tool.

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

• Not applicable: This is a mechanical implant, not an algorithm.

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

• Not applicable: For mechanical devices, performance is typically measured against established engineering standards (e.g., ASTM standards) rather than clinical ground truth types like pathology or outcomes data in the context of an AI model's performance. The "ground truth" here would be the physical properties and mechanical behavior of the device under test, compared to relevant standards or predicate devices.

8. The sample size for the training set

• Not applicable: This device is a mechanical implant and does not involve a "training set" in the sense of machine learning.

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

• Not applicable: As above, this concept does not apply to a mechanical implant.

In summary, the provided document relates to a 510(k) submission for a mechanical spinal implant. It confirms that mechanical testing was performed according to a guidance document for spinal systems. However, it does not offer the detailed information requested about acceptance criteria and a study design that would be relevant for an AI/algorithm-based medical device.

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