(159 days)
When used as a pedicle screw system, the Synthes Universal Spinal Parallel Connector is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lunbar-first sacral (LS-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion.
When used as a nonpedicle screw system, it is also intended for scoliotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disk disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; and fractures of the posterior thoracolumbar spine (levels T8-S2)
The overall levels of fixation are T8-S2.
The Synthes (USA) Universal Hook, Rod, and Pedicle/Sacral Screw Fixation System consists of rods, various hooks and screws, a trans-connector system, transverse bars and a parallel connector. The hooks and screws attach to the rod via a collar and a nut. The trans-connector system consists of a trans-connector bar and two trans-connector clamps. The trans-connector clamps attach to each rod; the trans-connector bar attaches to the transconnector clamps, and the clamps attach to the rod via a collar and a nut. There are additional components to the Synthes (USA) Universal Spinal System: transverse bars. It is manufactured from Ti-6Al-7Nb and 316L stainless steel.
The Synthes Universal Spinal Parallel Connector is provided non-sterile; moist heat sterilization is recommended
The provided text is a 510(k) summary for a medical device (Synthes (USA) Universal Spinal Parallel Connector) and focuses on describing the device, its intended use, and substantial equivalence to existing devices. It does not contain information about acceptance criteria, device performance metrics, study details, or ground truth establishment typically found in a clinical study report or a more detailed regulatory submission.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, expert involvement, adjudication, MRMC studies, standalone performance, or training set details.
The document only states that:
- The Synthes (USA) Universal Spinal Parallel Connector is substantially equivalent to the Texas Scottish Rite Hospital (TSRH) Crosslink Axial Plate, and the Cotrel Dubosset (CD) System Domino.
Substantial equivalence is a regulatory concept meaning that the new device is as safe and effective as a legally marketed predicate device. This determination is usually based on comparison of intended use, technological characteristics, and performance data (often non-clinical, such as mechanical testing, for devices like spinal connectors). The document mentions that the predicate system (TSRH Crosslink Axial Plate) is "similar in component dimensions and sizes" to the Synthes device, which is a key part of demonstrating substantial equivalence for this type of device.
To answer your questions, I would need a different type of document, such as:
- A clinical study report
- A pre-market approval (PMA) application summary
- A more detailed scientific publication about the device's performance
§ 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.