Search Results

The ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the ArcTec™ Semi-Rigid Plating System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

The ArcTec™ Semi-Rigid Plating System includes plates, bolts, washers and locking nuts in addition to standard surgical instrumentation. The semi-rigid low profile plate has a low stiffness and is easy to contour. The patent pending washer design incorporates a unique polyaxial bandclamp feature that allows unlimited range of placement on the plate and screw angulation of up to 10 degrees in any plane. The system combines the simplicity of a plate with the adaptability of a polyaxial screw connection.

The provided text describes a 510(k) premarket notification for the ArcTec™ Semi-Rigid Plating System. This is a medical device for spinal fixation, not an AI/ML-based device. Therefore, many of the requested criteria related to AI/ML device performance and testing (such as effect size of human readers with AI, standalone algorithm performance, training set details, and ground truth establishment for AI models) are not applicable to this document.

However, I can extract information regarding the device's performance justification based on the mechanical testing described.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test set: Not applicable in the context of an AI/ML device. For this mechanical device, the "test set" refers to the physical devices subjected to mechanical testing. The document does not specify the number of samples used for ASTM F1717 testing.
• Data provenance: Not applicable. The testing is described as mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Experts: Not applicable. This device is evaluated through mechanical testing, not by human experts establishing ground truth for diagnostic accuracy.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This concept is relevant for reconciling expert disagreements in diagnostic studies, which is not the case here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC study: No. This is a mechanical spinal implant, not an AI-assisted diagnostic tool for which MRMC studies would be conducted.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This device does not have an "algorithm only" component.

7. The type of ground truth used

• Ground truth: For mechanical performance, the "ground truth" is defined by the standards and metrics outlined in ASTM F1717 for spinal implant testing. The document does not specify which particular aspects of ASTM F1717 were evaluated (e.g., static compression, fatigue, etc.), but it refers to the standard generally.

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Ground truth for training set: Not applicable.

Summary of Device Performance Justification:

The ArcTec™ Semi-Rigid Plating System demonstrates its performance and safety through mechanical testing in accordance with ASTM F1717. This testing serves as the basis for establishing substantial equivalence to legally marketed predicate devices, considering its intended use, function, design, material, and overall mechanical performance. The FDA reviewed this information and found the device substantially equivalent.

Ask a specific question about this device