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The ATEC Lateral Plate System is intended for use via the lateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1- S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The ATEC Lateral Plate System is implanted through a lateral or anterolateral surgical approach to the thoracolumbar spine to provide temporary stabilization until fusion has occurred. The system will be comprised of both implants manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 for fixation and the required instruments to place them. ATEC Lateral Plate System implants will be provided in a range of sizes and lengths used to create a construct to immobilize the spinal segments.

This document is a 510(k) summary for the ATEC Lateral Plate System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. It explicitly states that clinical data was "Not applicable" for the determination of substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance.

Here's a breakdown of the requested information based on the provided text, primarily noting what is not present:

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

No acceptance criteria for performance (e.g., sensitivity, specificity, accuracy, etc.) are stated as this is not a diagnostic or AI/ML device requiring such metrics. The "device performance" in this context refers to nonclinical mechanical testing.

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

Not applicable. There was no clinical test set used for performance evaluation that involved human data. The testing mentioned is nonclinical (mechanical) and typically uses a set number of manufactured devices.

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

Not applicable. There was no clinical test set requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC study was not done. The document explicitly states "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

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

Not applicable. This device is a medical implant (plate system for spinal fixation), not an algorithm or AI/ML product.

7. The type of ground truth used

Not applicable. Clinical ground truth (e.g., expert consensus, pathology, outcomes data) was not used as no clinical performance study was conducted. The "ground truth" for the nonclinical testing would be the physical properties and mechanical behavior of the tested devices against established ASTM standards and predicate device data.

8. The sample size for the training set

Not applicable. This device is a medical implant, not an AI/ML product that would require a training set.

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

Not applicable. See response to #8.

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