(127 days)
The INNOVASIS 'Excella® Spinal System, when used for pedicle screw fixation is intended only for patients:
a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
C) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and
d) Who are having the device removed after the development of a solid fusion mass.
The INNOVASIS 'Excella®' Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture:
C) Dislocation:
d) Scoliosis:
e) Kyphosis:
f) Spinal tumor; and
g) Previous failed fusion (pseudoarthrosis).
The INNOVASIS 'Excella® Spinal System, when used for anterolateral nonpedicle fixation, is intended for the following indications:
a) Deqenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies):
b) Spinal stenosis;
C) Spondylolisthesis;
ರು) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudoarthrosis;
f) Tumor;
g) Trauma (i.e. fracture or dislocation); and
h) Previous failed fusion.
The INNOVASIS 'Excella® Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis);
e) Pseudoarthrosis;
() Tumor:
g) Trauma (i.e. fracture or dislocation);
h) Previous failed fusion.
The Excella® Spinal System broadens to include the Excella® -P bone screws, which feature a multi-axial joint for free motion of the screw head to allow the physician greater flexibility when placing the screws, and a series of 4.5mm diameter polyaxial bone screws of 30mm, 35mm, 40mm and 45mm lengths. The locking caps for Excella®-P are a two piece design which includes a threaded locking screw attached to an alignment cap. The alignment cap is attached to the bottom of the locking screw and rotates about the radial axis. The modified cross connectors come in various pre-assembled, adjustable lengths and allow for variation in vertical placement on two rods.
This document is a 510(k) submission for a spinal system, not for an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) for an AI device is not available in the provided text.
The document discusses the mechanical performance testing for the Innovasis Excella® Spinal System to demonstrate substantial equivalence to predicate devices, but this is related to the physical properties of the spinal implants, not a software or AI/ML product.
Therefore, I cannot provide the requested table and study details for an AI/ML device based on the provided text, as the device described is a physical spinal implant system.
§ 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.