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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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When labeled for pedicle screw fixation, the TiMX Low Back System is intended for use in Grade 3 and 4 spondylolisthesis at L5-S1, when affixed to the lumbosacral spine, utilizing autologous bone graft, and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

When labeled for non-pedicle screw posterior fixation, the TiMX Low Back System is intended for hook, wire and/or sacral/iliac screw fixation from the thoracic spine to the ilium/sacrum. Properly used, the posterior TiMX Low Back System will provide temporary stabilization as an adjunct to spinal bone grafting process. Specific indications are:

1. Idiopathic scoliosis.
2. Neuromuscular scoliosis/ kyphoscoliosis with associated paralysis or spasticity.
3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
4. Spinal fractures (acute reduction or late deformity).
5. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
6. Spondylolisthesis.
7. Neoplastic disease.
8. Previous Failed Fusion.

Levels of attachment for these indications range from T1 to the sacrum. This system is intended for single use.

All components of the TiMX Low Back System are made from implant grade titanium alloy conforming to ASTM F-136 specifications. TiMX pedicle and sacral screws, TiMX washers, TiMX slotted and cross connectors and TiMX Twister connectors are used in conjunction with the Isola System titanium components to comprise a rod based spinal fixation system.

TiMX Pedicle Screws are made from implant grade titanium alloy conforming to ASTM F-136 specifications. The TiMX Pedicle Screw is a variation of the existing titanium alloy pedicle screw previously cleared for the Isola Spinal System under K952236 and is the same screw that was found substantially equivalent for use with plates in K981274.

The machine thread portion of the TiMX pedicle screws are available in two thread lengths: Standard (30.0 mm) and No Cut +5 (17.0 mm). The No Cut +5 machine thread requires no cutting. Both the Standard and No Cut +5 thread length TiMX Pedicle screws are available in four cancellous diameters: 5.50 mm, 6.25 mm, 7.00 mm, and 7.75 mm. The larger size pedicle screws, 7.00 mm and 7.75 mm, may also be used in the sacrum. The cancellous portion of the Standard thread length is available in seven lengths that range from 25 mm to 55 mm in five millimeter increments. The cancellous portion of the No Cut +5 thread length is also available in seven lengths that range from 30 mm to 60 mm in five millimeter increments.

TiMX Sacral Screws are made from implant grade titanium alloy conforming to ASTM F-136 specifications. The TiMX Sacral Screw is a variation of the existing titanium alloy sacral screw previously cleared for the Isola Spinal System under K952236 and is the same screw that was found substantially equivalent for use with plates in K981274.

The TiMX Sacral Screw is designed with a larger diameter, 8.5 mm, for placement into the sacrum. TiMX Sacral Screws are available in the No Cut +5 (17.0 mm) machine thread length only. The No Cut +5 machine thread requires no cutting. The cancellous portion is available in four lengths that range from 35 mm to 50 mm in five millimeter increments.

TiMX Washers are manufactured from implant grade titanium alloy conforming to ASTM F-136 specifications. The TiMX Washer design is the same as previously cleared for the TiMX Low Back System under K981274. Washers are available in two styles: flat and tapered. Flat washers come in three sizes, 3 mm, 4.50mm and 5.0 mm. All edges of the washers are rounded. All washers have a chamfered inner hole for placement on the machine threaded portion of the TiMX screws. The tapered washer comes in one size with two different shaped inner holes: one round and the other oblong.

TiMX Connectors are manufactured from implant grade titanium alloy conforming to ASTM F-136 specifications. The Modular Cross Connector utilizes J-hooks which can be positioned anywhere along the construct to provide rod to rod connection. The TiMX Connector designs are a variation of titanium alloy Isola Slotted Connectors and the Modular Cross Connector and J-Hooks previously cleared for the Isola Spinal System under K952236.

The TiMX slotted connector assembly has two parts: a body and a set screw. Slotted connectors provide screw-to-connector-to-rod union. Slotted and offset designs are available in 14 inch diameters to accommodate the rod size. The slotted portion of each connector provides surgical latitude for screw placement. The machine threaded portion of the connector is locked to the screw with the nut. The rod is locked to the connector with the hexlobe set screw. The TiMX slotted connectors are offered in five designs: straight and extended (each with a 90° angle at the rod locking end), angled (with a 45° angle), offset left, and offset right.

TiMX Twister Connector is manufactured from titanium alloy conforming to ASTM F-136 specifications. The TiMX Twister Connector is a variation of the titanium alloy Isola Twister Connector previously cleared for the Isola Spinal System under K965046.

The Twister Connector, like other slotted connectors, provides a stable, strong and durable screw-to-connector-to -rod union. To provide secure fixation to the rod, a patented V-Groove Hollow Ground (VHG) design is used in all connectors. The two piece Twister connector design utilizes the attributes of the one piece connectors. It consists of a slotted transverse member with splines which mate with the splines of the V-Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7º increments.

The AcroMed TiMX Low Back System is a medical device for spinal fixation. The submission provided outlines the mechanical performance testing conducted to demonstrate substantial equivalence to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample sizes (number of constructs or components) used for each specific mechanical test. The data provenance is from bench testing conducted by AcroMed Corporation. The document does not specify country of origin for the data, but it is implied to be part of their regulatory submission to the US FDA. The study is a prospective test in the sense that the device was manufactured and then subjected to these specific tests to gather performance data.

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

Not applicable. This submission describes mechanical bench testing of an orthopedic implant, not a diagnostic device requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for this type of testing is derived from established engineering principles and ASTM standards for evaluating implant performance, not human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical properties of an implant, not its effectiveness in a clinical diagnostic setting involving human readers.

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

Not applicable. This is not an AI/algorithm-based device. The testing described is for the mechanical performance of a physical implant.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on:

• Engineering specifications and design requirements: The device must meet certain force, torque, and fatigue limits to be considered safe and effective.
• ASTM F-136 specifications: For material conformity (implant grade titanium alloy).
• Comparison to predicate device performance: The performance of the TiMX Low Back System was evaluated against the mechanical properties of the existing titanium alloy Isola Spinal Fixation System and standard titanium VSP pedicle screws, which were already cleared devices. The goal was to demonstrate "equal or superior" mechanical properties or "significant improvement."

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for the mechanical performance testing of an orthopedic implant. The tests described are direct evaluations of the device's physical properties.

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

Not applicable, as there is no training set in this context.

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