(29 days)
The Mercury Spinal System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anterolateral nonpedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
This system is intended to be used with bone graft.
Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws. Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone.
Screws, rods, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3.
The provided 510(k) summary for the Mercury Spinal System does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.
This document is a regulatory submission for premarket notification (510(k)) of a medical device. It focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than providing the type of performance study details requested for an AI/ML device.
Here's why the specific information requested cannot be extracted from this document:
- Device Type: The Mercury Spinal System is a mechanical implant (screws, rods, staples) for spinal fixation, not an AI/ML powered diagnostic or therapeutic device. Therefore, the concept of "accuracy," "sensitivity," "specificity," "reader studies," or "ground truth" as typically applied to AI/ML devices is not relevant in this context.
- Performance Data: The document states, "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use." This is the extent of the performance data description. It implies ISO/ASTM standard mechanical tests (e.g., fatigue, static strength, torsional strength) were performed, but specific acceptance criteria, test results, or study designs are not provided in this summary.
- Clinical Studies: For mechanical implants like this, clinical data (human subjects) is often not required for a 510(k) if substantial equivalence can be demonstrated through predicate devices and bench testing. There is no mention of human clinical trials, and thus no details on patient cohorts, expert readers, or ground truth establishment.
Therefore, I cannot populate the requested tables and sections with information from this document.
To answer your prompt with the provided input, I would have to state that the requested information is not present in the given 510(k) summary, as it pertains to an entirely different type of device and regulatory submission framework.
If you have a 510(k) summary for an AI/ML-powered medical device, I would be happy to analyze that for the requested details.
§ 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.