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The Medtronic Sofamor Danek PYRAMID® +4 ANTERIOR LUMBAR PLATE System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral lev :l below the bifurcation of the vascular structures or as an or anteriorly lateral placed supplemental fixation device for the 1.1 -L5 region.

When properly used, this system will ielp provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neo )lastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scolio is, lordosis, and/or kyphosis) associated with deficient posterior elements such as t at resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.

The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation of the vascular structures or laterally above the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by 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) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelcmenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic or liquity.

The subject device represents an expansion of the PYRAMID® ANTERIOR PLATE System. The prodicate system will be renamed the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. Like its predicate counterpart, the subject device is intended for use as an ant rior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons wit 1 options in the placement of the device to avoid interference with the vasculature, whil : still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.

The information provided describes the Medtronic Sofamor Danek PYRAMID® +4 Anterior Lumbar Plate System. This is a medical device, specifically an anterior lumbar plate system, and the provided document is a 510(k) summary for its premarket notification to the FDA.

Based on the provided text, the device's acceptance criteria are demonstrated through substantial equivalence to previously cleared devices rather than a performance study with specific metrics and thresholds. Therefore, a table of acceptance criteria and reported device performance in the traditional sense of diagnostic accuracy metrics cannot be fully generated.

However, I can extract the information to address the other points about the "study" that proves the device meets the acceptance criteria, which in this case is a comparative analysis for substantial equivalence.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not describe a clinical "test set" in terms of patient data. The "study" here is based on mechanical testing and a comparison to predicate devices. The sample size for these mechanical tests is not specified in the provided text.
• Data Provenance: The data provenance is primarily from in-vitro mechanical testing performed by the manufacturer, Medtronic Sofamor Danek. It is not patient data from a specific country or retrospective/prospective study.

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

This point is not applicable to this type of device submission. There was no "ground truth" established by human experts on a test set of data (e.g., medical images or patient outcomes). The assessment of substantial equivalence relies on the FDA's review team evaluating the provided documentation, including design specifications and mechanical test results, against predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring an adjudication method. The FDA's review process itself can be considered a form of adjudication but is not structured like a consensus-based ground truth establishment for a diagnostic device.

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

No, an MRMC comparative effectiveness study was not done or described for this medical device submission. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to evaluate human performance with and without AI. The PYRAMID® +4 Anterior Lumbar Plate System is a physical implant, not an imaging or diagnostic tool.

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

This question is not applicable. The device is a physical implant (anterior lumbar plate), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on the established safety and effectiveness of the identified predicate devices (PYRAMID® Anterior Plate Fixation System and XANTUS® Anterior Lateral Supplemental Fixation System), as well as engineering principles and mechanical testing to demonstrate that the new device performs similarly and is safe for its intended use. There is no biological or clinical "ground truth" in the typical sense of a diagnostic study (e.g., pathology, outcomes data).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical device. The device's design is based on engineering principles, existing medical knowledge, and the established designs of predicate devices, not on data used for machine learning.

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

Not applicable, as there is no training set. The "truth" for the design derives from engineering validation and comparison to established, legally marketed predicate devices.

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