(30 days)
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (LS-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.
Synthes Pediatric Rod System consists of rods, clamps, nut and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295). The Starlock clamps, Starlock screws and nut are composed of the titanium alloy TAN (ASTM F1295).
The 3.5mm rod is provided in four lengths, 80, 120, 240 and 300mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw, a 4.0mm cancellous screw, 4.0mm or 4.35mm expansion screw with 1.8mm locking screw, 3.5mm and 4.0mm cancellous and 3.5 cortical StarLock screws, medial, lateral, and upgoing, and offset StarLock clamps. Manual surgical instruments are included to implant components of this system.
The device functions as follows: The end of the rod, cut to an appropriate length, is inserted into the rod opening of the clamps and loosely tightened into position with the set screws included in the clamps. The awl is used to open the cortex. The K-wire is used to manually extend the hole. The length of screw is determined with the depth gauge, then the hole is tapped. The screw is inserted through the clamp at the desired level. The set screws are then locked down to the rod.
When the StarLock components are used with the 3.5 mm rod, the following assembly steps are followed after the screw hole is prepared and proper screw length determined: A StarLock screw is inserted at the desired level. A StarLock clamp is placed onto the screw and a StarLock nut is loosely threaded onto the head of the screw. The remaining screws, clamps and nuts are inserted in the same manner. A 3.5mm rod, cut to an appropriate length, is inserted into the rod opening of the clamps and loosely tightened into position with the set screws included with the clamps. After final adjustment of the construct, the set screws are locked down to the rod and the nuts are fully tightened.
This system is provided non-sterile; moist heat sterilization is recommended.
The provided text describes a 510(k) premarket notification for the Synthes Pediatric Rod System, a medical device for spinal fixation. It focuses on the device's components, function, and intended use as a pedicle screw fixation system for grade 3 or 4 spondylolisthesis in pediatric patients.
Notably, this document is a regulatory submission for premarket notification (510(k)) and not a scientific study or clinical trial report. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the device has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.
Therefore, the input does not contain information regarding:
- Acceptance criteria and reported device performance metrics from a study.
- Sample sizes, data provenance, or details of a test set.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi Reader Multi Case (MRMC) comparative effectiveness studies or effect sizes.
- Stand-alone (algorithm only) performance studies.
- Types of ground truth used in a study.
- Sample size for a training set.
- How ground truth for a training set was established.
The document confirms substantial equivalence to a predicate device (K980761) based on comparison of intended use and technological characteristics, not through a performance study against specific acceptance criteria.
If this were a document about a software algorithm or an AI/ML device, the requested information would be expected. However, for this type of mechanical spinal implant, performance is typically assessed through design specifications, material testing, mechanical testing (e.g., fatigue, static strength), and comparison to predicate device specifications, rather than the types of studies outlined in your request.
In summary, based solely on the provided text, I cannot complete the requested tables and information because the document does not describe a study involving acceptance criteria, performance metrics, ground truth, expert adjudication, or MRMC/standalone evaluations.
§ 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.