Search Results

The Pagoda™ Pedicle Screw 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, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T) -S1/lleum) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Pagoda™ Pedicle Screw System consists of rods, polyaxial screws, reduction screws, monoaxial screws, set screws, transverse connectors, and offset connectors which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. All components are made from Titanium Alloy (Ti6Al4V).

This document describes the acceptance criteria and study proving the device meets them for the Ortho Development® Pagoda™ Pedicle Screw System.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For the Pagoda™ Pedicle Screw System, the acceptance criteria are based on compliance with established ASTM standards for spinal implant mechanical testing and demonstrating substantial equivalence to predicate devices. The reported performance is that the device meets these criteria.

Dynamic Compression Testing
- Performed according to ASTM F1717

Static Torsion Testing
- Performed according to ASTM F1717

Overall Substantial Equivalence
- Demonstrated equivalence in mechanical performance to predicate devices (Pangea K052123, Tiger K113058, Synergy Helical Flange Plug K041449, MOSS Miami K964024) based on the specified mechanical tests, ensuring the Pagoda™ system performs at least as safely and effectively as legally marketed predicate devices.

Clinical Equivalence
- Demonstrated equivalence in intended use, design, materials, manufacturing methods, and packaging to predicate devices. This implies that the device is expected to perform similarly in clinical applications for the stated indications. | Met Criteria:
- The Pagoda™ Pedicle Screw System underwent and successfully passed static and dynamic compression testing per ASTM F1717.
- The Pagoda™ Pedicle Screw System underwent and successfully passed static torsion testing per ASTM F1717.
- Conclusion: "Mechanical test results demonstrate that the proposed Pagoda™ Pedicle Screw System is substantially equivalent to the predicate devices."
- Conclusion: "Based on similarities in intended use, design, materials, manufacturing methods, and packaging, Pagoda™ Pedicle Screw System has demonstrated that it is substantially equivalent to the previously cleared predicate devices."

The FDA's 510(k) clearance (K131785) confirms that the device has met the criteria for substantial equivalence to its predicates. |

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

This submission is for a medical device (pedicle screw system), not a software or AI algorithm. Therefore, the concept of a "test set" in the context of data used for an algorithm's performance evaluation is not applicable here.

• Sample Size for Test Set: Not applicable. The "test set" here refers to physical devices undergoing mechanical stress tests, not data. The document does not specify the number of individual components or systems tested, but it is implied that a sufficient number were tested to meet the requirements of the ASTM standards.
• Data Provenance: Not applicable in the context of patient data. The provenance for the testing is "non-clinical tests" conducted on the device itself.

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

Not applicable. "Ground truth" in this context would refer to material science and mechanical engineering standards established by organizations like ASTM, interpreted and applied by qualified engineers and technicians, not medical experts establishing truth from patient data. The document does not specify the number or qualifications of the individuals who performed or supervised the mechanical testing.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The "adjudication" is determined by whether the physical device passes or fails the specified mechanical tests according to ASTM F1717.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices or AI algorithms where human readers interpret medical images. The Pagoda™ Pedicle Screw System is a physical implant, and its evaluation focuses on mechanical integrity and substantial equivalence to predicate devices, not human reader performance.

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

Not applicable. The Pagoda™ Pedicle Screw System is a physical medical implant, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation comes from:

• ASTM Standard Specifications: The established mechanical performance requirements and methodologies outlined in ASTM F1717 for static and dynamic compression, and static torsion. These standards define what constitutes acceptable mechanical device performance.
• Predicate Device Performance: The mechanical and functional characteristics of the legally marketed predicate devices (Pangea, Tiger, Synergy Helical Flange Plug, MOSS Miami). The "ground truth" for substantial equivalence is that the new device performs at least as well as these established devices.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The product development process involves design, engineering, and manufacturing, followed by non-clinical testing.

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

Not applicable, as there is no "training set." The engineering validation process for physical devices relies on design specifications, material properties, manufacturing controls, and adherence to recognized industry standards (like ASTM) to ensure safety and effectiveness.

Ask a specific question about this device