(30 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 text describes the "Mercury™ Spinal System," a medical device, and its 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This document focuses on the regulatory approval process for a physical medical implant, not an AI/ML-based device.
Therefore, the information typically required for describing acceptance criteria and a study proving an AI/ML device meets them (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in the provided text, as these concepts are not applicable to the traditional mechanical testing and substantial equivalence demonstration for a spinal implant system.
The "Performance Data" section merely states: "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use." This is a high-level summary and does not provide specific acceptance criteria or detailed study results.
In summary, based on the provided input, it is not possible to fill out the requested table and answer the study-related questions that are specific to AI/ML device evaluations.
However, if we were to reinterpret the request in the context of what would be present for a traditional medical device like this, it would focus on mechanical and material properties. The "acceptance criteria" would typically be derived from recognized standards (e.g., ASTM F1717 for spinal implant constructs) and predicate device performance. The "study" would be mechanical testing.
Hypothetical Interpretation (Not directly supported by the provided text):
If this were an AI/ML device, the table would look something like this, but the data is not available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI/ML device):
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|
| Sensitivity ≥ 90% | Not provided in the document. |
| Specificity ≥ 85% | Not provided in the document. |
| AUC ≥ 0.92 | Not provided in the document. |
| Precision ≥ 88% | Not provided in the document. |
| F1-score ≥ 0.89 | Not provided in the document. |
| Time to result |
§ 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.