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The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes non-clinical mechanical testing of the device components. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable to this type of study as described. The testing involves physical samples of the pedicle screw system components.

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

Given this is a non-clinical mechanical performance study rather than a clinical study evaluating diagnostic or treatment outcomes, there were no experts used to establish ground truth in the way one would for clinical data interpretation. The "ground truth" for this study is defined by the established standards of ASTM F1717 for mechanical testing. Compliance with these standards is objectively measured.

4. Adjudication Method

Since no experts were establishing ground truth for a clinical test set, an adjudication method is not applicable. The testing involves objective physical measurements against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical substantial equivalence of a medical implant, not the effectiveness of a diagnostic or treatment method involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone "algorithm only" performance study was not done. This is a physical medical device, not a software algorithm. The "standalone performance" here refers to the mechanical integrity of the device components in isolation (i.e., without being implanted in a patient, but using standardized test fixtures). The study conducted was precisely that – standalone mechanical testing of the device components.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on established engineering standards (ASTM F1717) for mechanical performance and material specifications (ASTM F136). The performance of the Athena Pedicle Screw System was compared directly against these standards and to the mechanical performance of predicate devices that previously met these standards.

8. The Sample Size for the Training Set

Since this is a non-clinical mechanical study rather than a machine learning or clinical study, the concept of a "training set" is not applicable. The device's design is developed through engineering principles, not through training on a dataset.

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

As the concept of a "training set" does not apply to this type of study, the question of how ground truth was established for a training set is not applicable. The design and manufacturing processes are validated against engineering specifications and industry standards.

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