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EffortMed Spinal Fixation System is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the EffortMed Spinal Fixation System is intended to provide additional support during fusion using autograft in skeletally mature patients in the following acute and chronic instabilities or deformities:

• 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

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EffortMed Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the EffortMed Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis,fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The EffortMed Spinal Fixation System is intended to be used with autograft and/or allograft.

Device Description

EffortMed Spinal Fixation System is a top-loading, multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (Straight and curved) , connectors , hooks and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the U.S. FDA for the "EffortMed Spinal Fixation System." This document establishes the substantial equivalence of a new medical device to a legally marketed predicate device.

Crucially, this document is for a spinal fixation system (implants), not a software-based medical device or AI system. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to software/AI performance (e.g., accuracy, sensitivity, specificity studies with ground truth established by experts) are not applicable here.

Instead, for a spinal fixation system, "acceptance criteria" relate to biocompatibility, mechanical properties, and structural integrity. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) testing demonstrating that the device meets established standards for these properties, ensuring it is as safe and effective as the predicate device.

Here's how to interpret the information provided in the context of this specific device:

1. Acceptance Criteria and Reported Device Performance (as applicable to a physical implant):

The acceptance criteria for a spinal fixation system are typically defined by recognized consensus standards (e.g., ASTM standards) that evaluate the mechanical and functional performance of the device. The reported "performance" for such a device is not a single numerical output like an AI's accuracy, but rather the successful demonstration of meeting these standards.

Acceptance Criteria (based on common standards for spinal implants)	Reported Device Performance (based on provided text)
ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (evaluates static and fatigue properties of spinal implant constructs)	Tested: "ASTM F 1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" - Implies successful completion, demonstrating comparable static and fatigue properties to the predicate.
ASTM F1798: Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants	Tested: "ASTM F 1798: Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants" - Implies successful completion, demonstrating comparable performance of connectors and subassemblies.
Axial gripping capacity (of pedicle screws)	Tested: "Axial gripping capacity" - Implies successful completion, demonstrating adequate pullout strength.
Axial torque gripping capacity (of pedicle screws)	Tested: "Axial torque gripping capacity" - Implies successful completion, demonstrating resistance to loosening under torsional forces.
Flexion-extension moment (of the construct)	Tested: "Flexion-extension moment" - Implies successful completion, demonstrating stability under bending forces.
ASTM F543: Test Methods for Metallic Medical Bone Screws (covering various properties of bone screws)	Tested: "ASTM F543: Test Methods for Metallic Medical Bone Screws" - Implies successful completion, demonstrating compliance with general bone screw standards.
Annex A3-Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.	Tested: "Annex A3-Test Method for Determining the Axial Pullout Strength of Medical Bone Screws." - Implies successful completion of specific pullout strength testing.
Comparable shear failure force (following Chapman, J.R., et al principles)	Tested: "Determining the comparable shear failure force following the equation of Chapman, J.R., et al" - Implies successful completion, demonstrating adequate shear strength.
Tulip-dissociation testing on worst-case screw construct	Tested: "Tulip-dissociation testing on the worst-case bottom-loading screw construct at neutral and maximum screw angulations to evaluate the interconnection strength" - Implies successful completion, demonstrating the integrity of the screw head/rod interface.
Biocompatibility (Material safety)	Stated: "fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136." - Implies material safety and biocompatibility due to compliance with a recognized material standard.

2. Sample Size for Test Set and Data Provenance:

This information is not applicable in the AI/software sense. For a physical medical device like this, the "test set" refers to the physical units and materials subjected to bench testing. The "sample size" would relate to the number of components or constructs tested to meet statistical significance for the engineering tests. This detail is not typically included in a 510(k) summary, but rather in the full test reports. The "data provenance" (country of origin, retrospective/prospective) is also not relevant here, as it's not clinical data or real-world patient data.

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

This information is not applicable. Ground truth, in the context of an AI/software device, refers to a definitive diagnosis or finding established by human experts. For a physical implant, "ground truth" is defined by the objective, measurable outcomes of standardized engineering tests, not by expert consensus on images or patient data.

4. Adjudication Method for Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in establishing ground truth for diagnostic or AI performance studies. This is not relevant for bench testing of a physical implant.

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

No, a MRMC study was not done. MRMC studies are used to evaluate the impact of a medical device (often AI) on human reader performance, typically in diagnostic tasks. This device is a physical implant, not a diagnostic tool where human readers assess cases. The document explicitly states: "Clinical data: Not applicable."

6. If a Standalone Performance Study Was Done:

No, a standalone performance study (in the AI sense) was not done. A "standalone" study for AI refers to the algorithm's performance without human intervention. For this implant, the "performance" is its mechanical and material properties, which were evaluated via the listed ASTM standard tests. These are inherent properties of the device itself and don't involve "human-in-the-loop" interaction in the way an AI diagnostic tool would.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by objective, quantitative measurements obtained from standardized engineering and material tests (e.g., tensile strength, fatigue life, pullout strength, etc.) as defined by the ASTM standards listed. There is no expert consensus, pathology, or outcomes data used as "ground truth" for proving the device meets its acceptance criteria in the context of this 510(k). Its substantial equivalence is based on meeting these objective engineering standards and being comparable to the predicate device.

8. Sample Size for the Training Set:

This information is not applicable. A "training set" is used for machine learning models. This device is a physical implant and does not use machine learning.

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

This information is not applicable, as there is no training set for a physical implant.

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