(94 days)
The Mercury® and Overwatch® Spinal Systems are intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (TI -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. These systems are intended for anterior/ anterolateral non-pedicle 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.
These systems are intended to be used with bone graft.
The Spinal Elements Mercury Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.
When used for posterior non-cervical pedicle screw fixation in pediatic patients the Mercury and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the screws to help distribute loads placed against the bone.
Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.
The Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, set screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6A1-4V (ASTM F136).
The Overwatch Spine System is a multiple component system comprised of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, pedicle screws, set screws, transverse crosslinks, rod connectors, and hooks. When assembled, the components create a rigid structure to provide stabilization and promote spinal fusion. The systems screws are self-tapping and are available with either a cancellous or cortical cancellous dualfix thread design. The tulips are offered in low top, extended tab and tower configurations. All implant components of the Overwatch Spine System are manufactured from Ti-6Al-4V (ASTM F136) and are provided non-sterile for single-use. The system is to be used with bone graft material to facilitate spinal fusion.
This document is a 510(k) Premarket Notification from the FDA for the Mercury® and Overwatch® Spinal Systems. It establishes the substantial equivalence of these devices to previously cleared predicate devices. The information provided outlines the device description, indications for use, and performance data, but it does not describe a study meant to prove the device meets specific acceptance criteria in the way one might for a diagnostic AI device.
Instead, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The study described is a series of performance tests.
Here's the breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from FDA 510(k) process for substantial equivalence) | Reported Device Performance and Evidence in Document |
|---|---|
| Similar Indications for Use to predicate devices. | The Indications for Use for the Mercury® and Overwatch® Spinal Systems are stated to be substantially equivalent to the predicate devices. |
| Similar Technological Characteristics (design, intended use, operating principle, function) to predicate devices. | The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device. |
| Meets Performance Standards (mechanical and material properties) comparable to predicate devices. | Performance testing included: Static Axial Grip, Static Torsional Grip (both per ASTM F1798), Dynamic Compression Bending (per ASTM F 1717), Dynamic Flexion-Extension (per ASTM F1798), and Interconnection Strength (per ASTM F1798). All data indicates that the devices will perform as intended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes performance testing for a medical implant (spinal system), not a diagnostic algorithm. Therefore, the concept of "test set" and "data provenance" for patient data is not directly applicable in the same way.
- Sample Size: Not specified in terms of patient numbers. The "sample size" would refer to the number of devices or components tested in the mechanical performance tests. This information is typically detailed in the full test reports, which are not included here.
- Data Provenance: Not applicable in the context of patient data. The performance tests are laboratory-based mechanical tests.
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)
This is not applicable. The "ground truth" for this type of device is established through engineering and biomechanical standards (e.g., ASTM standards) and laboratory testing, not through expert consensus on medical images or clinical outcomes in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations, particularly for image-based diagnostics. This document is about mechanical performance testing.
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. MRMC studies are for evaluating diagnostic accuracy, particularly in imaging, with and without AI assistance. This document describes the mechanical performance of a spinal implant.
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 (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims for this device is based on accepted engineering standards (ASTM) for the mechanical and material properties of spinal implants. The device components are manufactured from materials conforming to specific ASTM and ISO standards (e.g., Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3). The performance tests (Static Axial Grip, Dynamic Compression Bending, etc.) are conducted according to these established standards.
8. The sample size for the training set
Not applicable. This device is not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI model that requires a training set.
§ 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.