Search Results

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the ARX® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The ARX-Link™ Cross Connector is a titanium alloy, multiple component system comprised of a variety of non-sterile single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The ARX-Link [M Cross Connector is available in various sizes. This device is an addition to the current system (K061600) and therefore is fully cross-functional within the current system.

The ARX-Link™ Cross Connector is a medical device and its performance was evaluated through biomechanical testing. The information provided in the 510(k) summary (K070995) details the study conducted to demonstrate its substantial equivalence to previously cleared devices.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated. For biomechanical testing of medical devices, the "sample size" typically refers to the number of test specimens (e.g., constructs with the ARX-Link™ Cross Connector) subjected to mechanical tests. The document only mentions that testing was "in accordance with ASTM F1717."
   • Data Provenance: Not applicable in the context of device biomechanical testing, as the data is generated from laboratory experiments on device prototypes/samples, not human or patient data.
   • Retrospective or Prospective: Not applicable for biomechanical testing.

2. Number and Qualifications of Experts for Ground Truth:

   • Not applicable. Ground truth for biomechanical testing is established by adherence to a recognized standard (ASTM F1717) and the physical properties/performance observed during the tests, not by expert interpretation of data like in clinical trials or image analysis.

3. Adjudication Method for Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical or imaging studies to reach consensus on difficult cases among multiple human readers. This is not relevant for objective biomechanical testing.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a spinal implant system.

5. Standalone Performance Study:

   • Yes, a standalone study was conducted in the sense that the device's mechanical performance was tested independently against the ASTM F1717 standard. This is not an "algorithm-only" performance as the device is a physical implant. The testing evaluates the physical device itself.

6. Type of Ground Truth Used:

   • Standardized Biomechanical Testing Results: The ground truth is derived from the objective measurements and pass/fail criteria defined by the ASTM F1717 standard for spinal implant constructs. This standard specifies test methods for determining the mechanical characteristics of spinal implant assemblies.

7. Training Set Sample Size:

   • Not applicable. This device is a physical implant, not an AI or software algorithm that requires a "training set." The design and manufacturing process would involve engineering specifications, materials science, and prototyping, but not data "training" in the machine learning sense.

8. How Ground Truth for Training Set Was Established:

   • Not applicable. As noted above, there is no "training set" in the context of this physical medical device. The "ground truth" for the device's design and manufacturing is established through engineering principles, material specifications (e.g., ASTM F136 for medical grade titanium alloy), and quality control processes to ensure compliance with design intent and safety standards.

Ask a specific question about this device