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The LowTop Pedicle Screw System is 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 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 (Pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

The LowTop System is intended for posterior, non-cervical pedicle fixation for the following indications:
Spondylolisthesis
Trauma (i.e., fracture or dislocation)
Spinal stenosis
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Pseudoarthrosis
Failed previous fusion

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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 S1) with removal of the implants after the attainment of a solid fusion.

The LowTop Pedicle Screw System is a spinal system that consists of screws, rods, connectors and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using a posterior approach.

The LowTop Pedicle Screw System is a spinal implant system. The provided text describes the device's mechanical testing, which served as the study to demonstrate it met the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

   Test Type	Acceptance Criteria (Standard)	Reported Device Performance
   Static Compression Bending	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"
   Static Torsion	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"
   Dynamic Compression Bending	ASTM F1717	"performed as designed and met, or exceeded, all product specifications"

2. Sample Size and Data Provenance:

   • The document does not specify the exact sample sizes used for each mechanical test.
   • The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. This was a laboratory study of a medical device, not a clinical trial with patient data.

3. Number of Experts and their Qualifications (for ground truth):

   • Not applicable. This device is hardware that underwent mechanical testing against engineering standards, not an AI or diagnostic device that requires expert-established ground truth from clinical data.

4. Adjudication Method (for ground truth):

   • Not applicable, as this was a mechanical testing study against established engineering standards rather than a clinical study requiring consensus among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This is a mechanical device, and such studies are typically for AI-powered diagnostic or interpretive tools.

6. Standalone Performance Study:

   • Yes, the "standalone" performance in this context refers to the device's mechanical integrity as an independent unit. The mechanical testing itself, conducted on the device, represents its standalone performance.

7. Type of Ground Truth Used:

   • The "ground truth" for this device's performance was the specifications and requirements outlined in the ASTM F1717 standard for spinal implant constructs.

8. Sample Size for the Training Set:

   • Not applicable. This is a mechanical device, not an algorithm that requires a training set.

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

   • Not applicable. There was no training set for this type of device.

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