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The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodvlolisthesis with objective evidence of neurologic impairment. fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis and kyphosis), tumor, fracture and previous failed fusion.

The MONARCH Spine System consists of pedicle screws, washers, spine plates, spinal rods, slotted connectors, dual rod connectors, J-hooks, polyaxial screws, open hooks, closed hooks, and spherical nuts.

Here's an analysis of the provided text regarding the MONARCH Spine System, focusing on the acceptance criteria and study information:

Based on the provided text, the MONARCH Spine System is a spinal fixation device, and the "performance data" mentioned refers to engineering tests to characterize the device's mechanical properties, not clinical studies involving human or AI evaluation. Therefore, many of your requested points regarding clinical study design are not applicable.

Here's the information that can be extracted or deduced from the text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "Performance data were submitted to characterize the MONARCH Spine System." However, it does not detail the specific acceptance criteria or the reported performance outcomes of these tests. This information would typically be in a more detailed performance data section of the 510(k) submission, which is not fully included here. The 510(k) summary focuses on the substantial equivalence against predicate devices for its intended use, implying that the performance data demonstrated equivalence in mechanical characteristics.

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

This is not applicable as the "performance data" refers to device characterization tests (e.g., mechanical testing of components or assemblies), not a clinical test set with patient data.

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

Not applicable. Ground truth for clinical data is not relevant here as there's no clinical test set described. For device performance testing, the "ground truth" would be established by engineering standards and validated testing methodologies, not clinical experts.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set mentioned.

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 is a spinal implant, not an AI-powered diagnostic device, and no MRMC study or AI-assistance is mentioned.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

For the device's mechanical performance, the "ground truth" would be the established engineering standards and specifications to which the device was designed and tested (e.g., ASTM standards for implant materials and mechanical performance). It relies on physical measurements and adherence to specified limits rather than expert consensus or patient outcomes directly for the "performance data" section.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this device does not involve machine learning.

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

Not applicable. No training set is mentioned.

Summary of Device Performance and 510(k) Process:

The provided document is a 510(k) summary for the MONARCH Spine System. The "performance data" mentioned refers to the engineering and mechanical testing required to demonstrate that the device is substantially equivalent to legally marketed predicate devices (ISOLA Spinal System, K993030; Tri-Fix Spinal Fixation System, K011830).

The key takeaway from this document is that the FDA reviewed these performance data and determined that the MONARCH Spine System, for its stated indications for use, is as safe and effective as the predicate devices. The focus of a 510(k) is typically on demonstrating this substantial equivalence through a comparison of technological characteristics and performance data, not through extensive clinical studies as required for a Class III device with a PMA.

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