(76 days)
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.
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Characterization of Mechanical Properties | Not explicitly detailed in this summary |
| (Likely included tests for strength, fatigue, torsional stability, etc., to ensure equivalence with predicate devices) | Performance data submitted and deemed sufficient for substantial equivalence. |
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.