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The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Exactech Proliant Polyaxial Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.

This submission proposes a new pedicle screw spinal fixation system. The proposed Proliant Polyaxial Pedicle Screw System is a top-loading spinal fixation system that comprises various sizes of polyaxial screws, rigid rods and cross connectors to provide 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136). The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.

The Proliant Polyaxial Pedicle Screw System includes a complete instrumentation system to assist the surgeon in the implantation of each component according to a traditional open surgical procedure.

The provided text describes a 510(k) submission for the Exactech® Proliant™ Polyaxial Pedicle Screw System. This is a medical device for spinal fixation, and the summary focuses on demonstrating "substantial equivalence" to predicate devices rather than proving a new clinical benefit or performance against specific, quantifiable acceptance criteria in the way a diagnostic AI device might.

Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of document. The study described is a biomechanical engineering study, not a clinical study involving human patients or ground truth derived from expert review or pathology.

Here's a breakdown based on the available information:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a spinal fixation system, the "acceptance criteria" are not reported as specific performance metrics with thresholds (e.g., sensitivity, specificity thresholds for AI). Instead, acceptance is demonstrated by showing "substantial equivalence" to legally marketed predicate devices through biomechanical testing, indicating the device can withstand "clinically relevant biomechanical loads."

• Static Compression Bending, Static Torsion, and Dynamic Compression Fatigue testing per ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
• Biomechanical assessment comparing Proliant Polyaxial Pedicle Screw System mechanical performance to cited predicate systems. The results "demonstrate the proposed devices are substantially equivalent to cited predicates." |

Study Details

• 1. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" in this context refers to mechanical test specimens (e.g., spinal implant constructs). The document does not specify the number of samples tested for each biomechanical test (Static Compression Bending, Static Torsion, Dynamic Compression Fatigue). The testing is laboratory-based mechanical testing, not a clinical study on human data.
• 2. Data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is biomechanical laboratory testing.
• 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 mechanical performance is established by the physical testing results against engineering standards and comparison to predicate devices, not by expert human review.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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 not an AI/diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the physical performance as measured by standardized mechanical testing (ASTM F1717) and engineering analysis compared to the established performance of predicate devices.
• 8. The sample size for the training set: Not applicable. This is not a machine learning/AI device.
• 9. How the ground truth for the training set was established: Not applicable.

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