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The MANTIS® Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

This Special 510(k) submission is intended to introduce a line extension to the MANTIS Spinal System, which entails additional diameter size cannulated polyaxial screw components as well as additional straight rod components in a variety of lengths. Modifications were made to the existing MANTIS Spinal System (K061813) to render the new components. The MANTIS Spinal System will include cannulated polyaxial screw, pre-bent rod and straight rod components that can be used via either a percutaneous surgical approach or a standard open approach.

The provided text does not describe the acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) summary for a spinal fixation system, focusing on its substantial equivalence to predicate devices and its intended use.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the given input.

The document discusses:

• Proprietary Name: MANTIS® Spinal System
• Common Name: Spinal Fixation Appliances
• Regulatory Class: Class III
• Device Product Code: 87 MNH, 87 MNI, 87 NKB
• Predicate Devices: Stryker Spine MANTIS Spinal System (K061813), Stryker Spine Xia® Titanium Spinal System (K013823, K043473, K002858, K060361), and Stryker Spine Osteonics Spinal System (K951725).
• Description of Device Modification: Line extension including additional diameter size cannulated polyaxial screw components and additional straight rod components.
• Intended Use: Posterior, non-cervical pedicle fixation for indications such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion.
• Technological Comparison: States that the additional screw and rod components have equivalent mechanical properties to the predicate devices and are made from the same materials.

Missing Information:

The document does not contain any information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader, multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This is a regulatory submission aimed at demonstrating substantial equivalence based on material and mechanical properties compared to already cleared devices, not a study evaluating performance against specific acceptance criteria for a new feature or algorithm.

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