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The MX Monoaxial Pedicle Screw is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system the MX Monoaxial Pedicle Screws are indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The MX Monoaxial Pedicle Screw consists of pedicle screws and rods. Pedicle screws are inserted into the pedicles of the vertebrae and are available in two diameters (Ø5.5 and Ø6.2mm) and in lengths ranging from 30mm to 55mm. A rod is then placed through the screws. The rods are available in lengths ranging from 45-600mm. Two rod loading configurations are available. A closed screw is similar to the predicate screw with the head of the screw enlarged and the rod is slid through an opening in the head. A side loading configuration is similar to the closed screw except that there is an opening in the side of the screw head and the rod slid into this opening.

The document you provided is a 510(k) summary for the Scient'x MX Monoaxial Pedicle Screw. This document describes a medical device (a pedicle screw system) and its substantial equivalence to a predicate device, based on nonclinical testing.

Therefore, there is no information present in this document about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies. The document focuses on the mechanical and material aspects of the device in comparison to an already approved device.

Here's why the requested information is absent and what is provided:

• Acceptance Criteria/Reported Device Performance (Table): Not applicable. This device is a physical implant, and its "performance" is evaluated through mechanical testing, not diagnostic metrics like sensitivity, specificity, or AUC. The document states "Testing was performed per ASTM F1717 and is comparable to the predicate device." This is the core of their performance claim.

• Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" of patient data in the context of an AI/ML algorithm or diagnostic study. The testing refers to biomechanical tests on the screws themselves.

• Number of Experts and Qualifications: Not applicable. No human experts were involved in establishing ground truth for evaluating a diagnostic algorithm.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a diagnostic imaging or AI-assisted device.

• Standalone Performance: Not applicable. The device itself is a physical implant; it doesn't have "standalone algorithm performance."

• Type of Ground Truth: Not applicable. There's no ground truth in the sense of a medical diagnosis. The ground truth for this type of device is compliance with mechanical standards (e.g., breaking strength, fatigue life).

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI model.

• How Ground Truth for Training Set Was Established: Not applicable.

What the document does tell us about performance and acceptance criteria:

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the MX Monoaxial Pedicle Screw performs comparably to the predicate device (Scient'x Closed Pedicle Screw system, K020245) according to specific ASTM standards.
• Study Proving Device Meets Acceptance Criteria: The study involved "Nonclinical Tests" performed "per ASTM F1717." This standard (ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) specifies mechanical test methods for spinal implants. The document asserts that the results of these mechanical tests demonstrate comparability to the predicate device.

In summary, the provided text is for a physical medical device (pedicle screws) and not for an AI/ML diagnostic system. Therefore, the specific questions regarding AI/ML study design and performance metrics are not applicable and cannot be answered from this document.

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