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The LDR Spine USA Easyspine System is a posterior, non-cervical, pedicle 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: spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis (with objective evidence of neurologic impairment), trauma (i. e., fracture or dislocation), spinal stenosis, deformities or curvatures (i. e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Easyspine implants are single use devices for mono-and multi-segmental stabilization of the lumbar and thoracic vertebrae to promote fusion. The Easyspine System consists of sacral and pedicle screws, cross-connections, and rods of different rigidities. Specialized associated instrumentation is designed for implantation of these devices and for the distraction, compression or reduction of the lumbar and thoracic spine. The implants are made of surgical titanium alloy Ti6AI4V (ASTM F-136-92). Instruments used to implant Easyspine® are made of medical grade stainless steel. Both the Easyspine LP and Easyspine LP Multiaxial designs consist of various screws, rods, and connectors which are intended to provide temporary stabilization following surgery to fuse the thoraco-lumbar spine. The systems include side-loading screws which are offset as compared to the standard configuration. This offset allows separate rod tightening and polyaxiality locking. Additionally, the system facilitates conducting spondylolisthesis reduction by allowing bone screwing after rod tightening. The lateral offset loading feature incorporated into the designs has not altered the fundamental technology of the predicate Easyspine pedicle screw system. Operatively inserted implants serve to support the normal healing process. They are not intended to replace normal body structures, nor in cases of incomplete healing, to withstand the continually applied loading conditions.

The Easyspine® System, specifically the 6 mm and 7 mm diameter LP and LP Multiaxial pedicle screws, underwent non-clinical performance testing to demonstrate substantial equivalence to a predicate device (K043094 - LDR Spine USA Easyspine System).

Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The study was a non-clinical performance study and involved mechanical testing in accordance with ASTM 1717-04. Therefore, it did not involve human patients or clinical data for a "test set" in the traditional sense of a clinical trial.

• Sample Size: Not explicitly stated in terms of a number of "samples" but implied to be sufficient for testing according to ASTM 1717-04. This would typically involve multiple test specimens of the screws and associated components to ensure statistical validity.
• Data Provenance: The data is from laboratory testing (mechanical performance testing) of the device. There is no country of origin for human data, as no human data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. This was a non-clinical, mechanical performance study. "Ground truth" was established by the ASTM 1717-04 standard, which defines the testing methodology and performance parameters for spinal implant constructs. No human experts were required to establish ground truth for this type of testing.

4. Adjudication Method for the Test Set:

Not applicable. As a non-clinical mechanical performance study, there was no need for adjudication by multiple experts. The results were based on objective measurements against the specified ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This submission is for a medical device (pedicle screw system), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance was involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used was mechanical performance data comparison against a legally marketed predicate device (K043094) and compliance with the ASTM 1717-04 standard. This standard serves as the established "ground truth" for evaluating the mechanical integrity and performance of spinal implant constructs.

8. The Sample Size for the Training Set:

Not applicable. As this is a non-clinical performance study for a physical device, there is no "training set" in the context of machine learning or AI models.

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

Not applicable. There was no training set involved in this non-clinical performance study.

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