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The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication: spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

In addition, the Aaxter A3 Posterior Spinal 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

· Degenerative spondylolisthesis with objective evidence of neurological impairment

· Fracture of the vertebral body

· Dislocation

· Scoliosis

· Kyphosis

· Spinal tumor

The Aaxter A3 Posterior Spinal System is a posterior spinal system which is a top loading multiple components, posterior pedicle and hook fixation system intended to provide segmental stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.

The Aaxter A3 Posterior Spinal System consists of variety of rods, hooks, screws, and cross links used to build a spinal construct for stabilization and promotion of spinal fusion in the thoracic-lumbar and sacral regions.

The Aaxter A3 Posterior Spinal System implant system components are supplied non-sterile for single use and are made from medical titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Specialized instruments made from surgical grade stainless steel are used for all the operations of the Aaxter A3 Posterior Spinal System.

Here's a breakdown of the acceptance criteria and study information for the Aaxter A3 Posterior Spinal System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the exact sample sizes (e.g., number of test constructs, individual screws, rods) for each mechanical test. It only states that these tests were performed according to ASTM standards.

The data provenance is not explicitly mentioned. Given it's a regulatory submission from a company in Taiwan (Aaxter Co., Ltd), the testing was likely conducted in a lab affiliated with the company or a certified testing facility, potentially within Taiwan or another country capable of performing the specified ASTM tests. This was a retrospective evaluation as it was part of a 510(k) submission, confirming the device's substantial equivalence to existing devices.

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

This information is not applicable to this type of device submission. The "ground truth" for a mechanical orthopedic implant like the Aaxter A3 Posterior Spinal System is established through adherence to recognized international standards (ASTM F1717 and ASTM F1798) and comparison to predicate devices, rather than expert clinical consensus or pathological review of patient data. The "ground truth" here is the performance metrics defined by the standards and the performance of previously cleared devices.

4. Adjudication Method (for the test set)

This information is not applicable. Mechanical tests against standards do not typically involve adjudication in the human expert sense. The results are objective measurements compared against specified criteria and predicate device data.

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

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic algorithms or imaging interpretation, not for mechanical orthopedic implants.

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

This information is not applicable. This device is a physical pedicle screw spinal system and does not involve algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is the mechanical performance standards (ASTM F1717 and ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal was to demonstrate "substantial equivalence" to these benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set" in the machine learning sense. The design and manufacturing processes are informed by engineering principles and material science, not data training.

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

This information is not applicable for the reasons stated above.

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