(262 days)
MNH - When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:
- having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- receiving fusions using autogenous bone graft only; .
- having the device fixed or attached to the lumbar and sacral spine; and
- . having the device removed after the development of a solid fusion mass.
MNI - Posterior pedicle systems are 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 (T-10 - S1/2):
- degenerative spondylolisthesis with objective evidence of neurologic impairment .
- fracture
- dislocation
- . scoliosis
- kyphosis
- . spinal tumor
- failed previous fusion (pseudarthrosis) .
The ORIA CLARIS includes implantable components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system to fit the patient's individual anatomical and physiological requirements. Selection of the necessary components is addressed in the surgical protocol. The titanium components are made of surgical implant grade CP Titanium and titanium alloy (6al4Vti). The basic system components include: Connectors, Nuts & Locking Screws, Rods, Crosslinks, Pedicle Screws, Sacral Screws, Unique Instrumentation. The system consists of a series of alloy compatible parts from which various spinal assemblies or constructs may be fashioned. Specially designed connectors, interconnection mechanisms incorporating nuts, screws; longitudinal members (rods) and/or transverse connectors, sacral screws and pedicle screws are offered. The levels of attachment (depending on specific indication) are lumbar and thoracic spine, and the sacrum and may only be used posteriorly.
This appears to be a 510(k) premarket notification for a medical device (ORIA CLARIS Posterior spine system). The provided document describes the device, its indications for use, and regulatory compliance, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined for performance studies of AI/diagnostic devices.
The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Eurosurgical, S.A., K021679) for regulatory approval, rather than presenting a performance study with specific acceptance criteria and detailed methodology using a test set, ground truth, experts, etc.
Therefore, I cannot populate the table or provide the requested information because the provided text does not contain:
- Explicit acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
- A "study" in the sense of a clinical trial or a performance evaluation against a defined ground truth on a test set. The closest it comes to "testing" is mentioning compliance with material, mechanical, and biocompatibility standards, and sterilization cycle validation, but these are not performance studies as typically described for AI/diagnostic devices.
- Sample size used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used (beyond general material/mechanical standards).
- Sample size for a training set.
- How ground truth for a training set was established.
The document's purpose is to satisfy regulatory requirements for market clearance based on substantial equivalence to an existing device, which often relies on demonstrating similar design, materials, and intended use, rather than novel performance benchmarks.
§ 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.