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When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MN), The AMT Spinal™ System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine (1) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis).

The AMT Spinal™ Svstem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5-S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The AMT Spinal™ System is designed for use as a construct system and consists of set screws, hex nuts, hooks, rods, screws, and cross link assembly (cross link rod and connecting hook) which can be variously assembled to provide immobilization of the thoracic. lumbar, and lumbosacral spine. The system is composed of the following components: right hand set screw, left hand hex nut, pedicle screw, polyaxial screw, rod, cross link assembly (cross link rod and connecting hook). All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136).

The components under review are the Polvaxial screws. Polyaxial upper body head, and concave compression washer. The AMT Polyaxial Pedicle Screw serves as an additional option to the pedicle screw configurations currently offered in the AMT Spinal™ System (K002059). in a construct system. The AMT Polyaxial Pedicle Screw utilizes the same straight forward simple instruments and is identical to the pedicle screws currently offered in the AMT Spinal™ System in the all areas with the exception of the following:

The top loading polyaxial head allowing for greater positioning abilities.

• The rotating head (polyaxial) eliminates the need to bend rods for constructs up to the . three (3) vertebral levels.
• The rotating head (polyaxial) can be rotated allowing the surgeon greater versatility in ● positioning rod and screws to the anatomy.
• Allows anatomical screw placement and easy rod positioning. ●
• This allows the surgeon multi-angle pedicle screw insertion. .
• All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136). Materials:

Function: The system functions to assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine.

The provided document does not describe a study involving an AI/Machine Learning device or software. Instead, it's a 510(k) premarket notification for a spinal implant system: the Micron Precision Engineering AMT Spinal™ System, specifically the AMT Polyaxial Pedicle Screw.

Therefore, I cannot provide information about acceptance criteria or studies related to AI performance, as the document details:

• Mechanical testing of a physical medical device. The "study" mentioned is non-clinical performance testing for static and fatigue compression and static torsion of the pedicle screw, performed according to ASTM F1717-96.
• A "substantial equivalence" determination by the FDA, comparing the proposed device to legally marketed predicate devices. This process does not involve clinical trials with human subjects for this type of device, nor does it involve AI performance validation.

Here's what I can extract from the document regarding the device's performance and the basis for its clearance, as per the request, but adapted to the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a physical medical device (spinal implant), the "acceptance criteria" are not reported as specific performance metrics against a predefined threshold like sensitivity, specificity, or AUC for an AI model. Instead, the acceptance criteria are generally met by demonstrating substantial equivalence to predicate devices and verifying mechanical performance through established standards.

The following points (2-9) are not applicable as this is not an AI/ML device study:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the biomechanical samples tested in a lab, not a data set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering standards and physical measurements.
4. Adjudication method for the test set: Not applicable.
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 physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used: For mechanical testing, the "ground truth" is derived from established engineering principles, material properties, and the performance requirements of the ASTM F1717-96 standard. For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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