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"Paonan" Armstrong Posterior System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacraliliac spine (T1-Sacrum/Tium) for the following indications:

• Degenerative disc diseases (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) degeneration of the disc confirmed by history and radies)
• Degenerative Spondylolisthesis with objective evidence of neurologic impairment.
• Fractures
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
• Failed previous fusion (pseudarthrosis)

"Paonan" Armstrong Posterior Spinal Fixation System includes pedicle screws, rods, cross connectors, and associated instruments. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

The document describes the "Paonan" Armstrong Posterior Spinal Fixation System, a medical device for spinal immobilization and stabilization. It outlines the acceptance criteria and the study performed to demonstrate its substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression Bending Test
• Dynamic Compression Bending Test
• Static Torsional Test (for spinal construct) | Performed, demonstrating "satisfactory mechanical performance" (implied as being equivalent to the predicate, though specific numerical results are not provided in this summary). The summary states, "The results demonstrate substantial equivalence of the 'Paonan' Armstrong Posterior Fixation System to the predicate device." |
  | Mechanical Testing per ASTM F1798:
• Axial Gripping Capacity Test
• Torsional Gripping Capacity Test (of Cross Link and Connecting Block interconnection mechanism) | Performed, demonstrating "satisfactory mechanical performance" (implied as being equivalent to the predicate). The summary states, "The results demonstrate substantial equivalence of the 'Paonan' Armstrong Posterior Fixation System to the predicate device." |

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

The document discusses mechanical testing of the device components, not clinical data from patients. Therefore, the concepts of "test set sample size" and "data provenance (country of origin, retrospective/prospective)" as they relate to human subjects or retrospective/prospective studies are not applicable in this context. The study performed involves laboratory-based mechanical tests of the physical device components.

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

This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717, ASTM F1798) and the performance of the predicate device, not by expert human interpretation of images or patient data. The evaluation is based on objective measurements and comparison to defined metrics derived from the standards and predicate.

4. Adjudication Method for the Test Set

This is not applicable. As the study involves mechanical testing against engineering standards, there is no human adjudication process involved in establishing test results or "ground truth." Results are determined by measurement and comparison to predefined criteria.

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

This is not applicable. An MRMC study pertains to the evaluation of diagnostic devices that rely on human interpretation of images or data, often comparing AI performance with and without human assistance. This document describes mechanical testing of a spinal fixation system, not a diagnostic AI device.

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

This is not applicable. The device is a physical spinal fixation system, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's mechanical performance is defined by:

• Established engineering standards: Specifically ASTM F1717 (for static/dynamic compression bending and static torsion of spinal constructs) and ASTM F1798 (for axial and torsional gripping capacity).
• Predicate device performance: The "Paonan" Armstrong Posterior Spinal Fixation System's performance was compared to the predicate system (MYKRES Spinal System, K051704) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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