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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, scoliosis, 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 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.

Addition of 5.5mm diameter rod, screws, hooks and various connectors to the MONARCH Spine System. The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for the MONARCH Spine System, an addition of 5.5mm diameter rod, screws, hooks, and various connectors. It is a medical device submission, and therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics against an AI algorithm.

Regarding your numbered requests, based only on the provided text, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria (Implied)	Reported Device Performance
   Safety and Effectiveness substantially equivalent to predicate devices	Performance data were submitted to characterize the MONARCH Spine System. (Specific results not detailed in the provided text.)
   Manufactured from ASTM F-136 implant grade titanium alloy	Manufactured from ASTM F-136 implant grade titanium alloy.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document states "Performance data were submitted to characterize the MONARCH Spine System." However, it does not provide details on the sample size used for the test set, the provenance of the data (e.g., country of origin), or whether the data was retrospective or prospective. This information would typically be found in the detailed performance data report, which is not included in this summary.

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):
   As this is a mechanical medical device (spinal implant), the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The "performance data" would likely refer to mechanical testing, biocompatibility testing, and potentially animal or clinical performance data if submitted, but not expert consensus on images. The document does not mention experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable for this type of device and performance data. The document does not mention any adjudication method.

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:
   This device is a spinal implant, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This device is a spinal implant, not an algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For a spinal implant, "ground truth" would generally refer to established engineering standards for mechanical strength, fatigue, biocompatibility, and potentially clinical outcomes if a clinical study was performed. The document vaguely states "Performance data were submitted to characterize the MONARCH Spine System." It does not specify the type of ground truth used beyond the implicit requirement of meeting established regulatory and engineering standards for similar devices.

8. The sample size for the training set:
   This device is a physical implant, not a machine learning algorithm that requires a "training set." Therefore, the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established:
   As there is no training set for this type of device, this question is not applicable.

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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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The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis 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, lordosis and kyphosis), tumor, fracture and previous failed fusion.

The MONARCH Commercially Pure Titanium Spinal Rod is a 6.35mm diameter rod available in various lengths.

The provided text describes a 510(k) submission for the MONARCH Spine System Commercially Pure Titanium Spinal Rod. This is a medical device submission, and the content focuses on establishing substantial equivalence to a predicate device, as required for 510(k) clearances. The text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of AI/ML or diagnostic performance.

Instead, the "Performance Data" section merely states: "Performance data were submitted to characterize the MONARCH Commercially Pure Titanium Spinal Rod." This typically refers to mechanical, material, or biocompatibility testing required for a physical medical device, not a diagnostic or AI-driven system.

Therefore, I cannot fulfill your request for information related to acceptance criteria, device performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided document.

The document pertains to the regulatory clearance of a physical spinal rod, not an AI/ML diagnostic or predictive device.

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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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