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The Monarch Spine System is a pedicle screw system intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Monarch Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Monarch Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Monarch Spine System Dual Rod Connectors can be used to connect Monarch Spine System Rods to rods of other DePuy AcroMed 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

The Monarch Spine System is both a rod-based and plate-based system designed to interface with various spinal anatomies. The plate-based system consists of pedicle screws, spine plates, ISOLA Modular Cross Connector (MCC) transverse connectors, J-hooks, washers, and nuts. The rod-based system consists of spinal rods, pedicle screws, polyaxial screws, caps, various slotted connectors, open and closed hooks, various rod-to-rod connections, ISOLA Modular Cross Connector (MCC) transverse connectors, and ISOLA EZ-X transverse connectors.

The Monarch Spine System is manufactured from implant grade titanium alloy that conforms to ASTM standard F-136.

This document is a 510(k) premarket notification for the Monarch Spine System. It focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria or a dedicated study report for performance. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states that substantial equivalence is based on "equivalence in design, materials, manufacturing methods, intended use, and relative indications and contraindications" to predicate devices, but no specific performance criteria or their achievement are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no pre-market clinical or performance study beyond substantial equivalence comparison is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no independent expert ground-truthing for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is described.

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: Not applicable. This device is a spinal fixation system, not an AI-driven diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Monarch Spine System is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for performance evaluation is described.

8. The sample size for the training set: Not applicable. The device is a physical implant, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is available in the document:

• Device Name: Monarch Spine System
• Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion, severe spondylolisthesis (Grades 3 and 4) of L5-S1, degenerative disc disease, trauma, spinal stenosis, deformities).
• Basis for Clearance: Substantial equivalence to predicate devices (TiMX Low Back System, Moss Miami Spinal System, ISOLA System) based on equivalence in design, materials, manufacturing methods, intended use, and indications/contraindications.
• Material: Implant grade titanium alloy conforming to ASTM standard F-136.

The provided text is a 510(k) summary, which is a pre-market notification to the FDA. Its purpose is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than to present detailed de novo performance study results against specific acceptance criteria.

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