(27 days)
The Momentum Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum™ Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
In order to achieve additional levels of fixation, the Momentum Posterior Spinal Fixation System can also be connected to the Cortium® Universal OCT Spinal Fixation System or neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the Cortium or neon3 Instructions for Use for a list of indications for use.
The Momentum® Posterior Spinal Fixation System is a standard pedicle screw and rod systems designed for fixation and correction in the thoracolumbar and sacroiliac spine. This 510(k) submission adds hooks, various connectors, and monoaxial screws to the previously cleared system from K231809 and K191932.
The subject hooks are intended to provide deformity correction according to patient anatomical needs. The subject connectors are intended to provide additional options to improve stability. The subject monoaxial fenestrated screws are identical below the tulip to the previously cleared fenestrated screws with the addition of the option to use G21 V-Steady bone cement. The Momentum® Posterior Spinal Fixation System is manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 and cobalt chromium Co-Cr-28Mo per ASTM F1537 and ISO 5832-12.
This document is a 510(k) premarket notification decision letter for a medical device called the "Momentum® Posterior Spinal Fixation System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.
The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the device's indications for use, technological characteristics, and performance data (mechanical strength testing results) to existing predicate devices.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study data for an AI/ML powered device based solely on the provided text. The document concerns a traditional implantable medical device, not an AI/ML product.
To reiterate, the provided text does not contain any of the following information:
- A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device with performance metrics like sensitivity, specificity, etc.
- Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to mechanical testing of physical components, not a data-driven model.
- Number of experts used to establish the ground truth...: Not applicable, as ground truth is not established in the context of an AI/ML model for this device.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The performance data mentioned (ASTM F1717 Dynamic Compression Bending) refers to mechanical testing of the spinal fixation system components to ensure their structural integrity and durability, not the performance of an AI/ML algorithm.
§ 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.