(52 days)
The Novel III Spinal System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Novel Spinal System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The Novel ///™ Spinal Fixation and Adjustable Bridge System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Novel III TM Spinal Fixation and Adjustable Bridge System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Novel ///™ Spinal Fixation and Adjustable Bridge System implants.
The provided text is a 510(k) summary for the Novel III™ Spinal Fixation and Adjustable Bridge System, which is a medical device. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through mechanical testing and comparison of design and intended use.
Therefore, the document does not contain the information requested in points 1-9, as those details are typically associated with clinical trials or studies assessing diagnostic performance, which are not relevant for this type of device submission.
Here's a breakdown of why the information is not present:
- Acceptance Criteria and Device Performance (1): Not applicable for this type of device. The acceptance criteria here would be meeting the mechanical testing standards (ASTM F 1717-04 for the predicate, and implied substantial equivalence for the modified device). No specific reported "performance" in the sense of diagnostic accuracy or a clinical outcome study is provided or required for a device modification of this nature.
- Sample Size, Data Provenance (2): No clinical test set involving patients is described. The "test set" refers to the components tested in mechanical validation.
- Number of Experts, Qualifications (3): No expert ground truth establishment for a test set is described.
- Adjudication Method (4): Not applicable as there's no interpretation of clinical data by experts.
- MRMC Comparative Effectiveness Study (5): This is a mechanical device, not an AI or diagnostic tool where human readers would improve with AI assistance.
- Standalone Performance (6): "Algorithm only without human-in-the-loop performance" is not relevant for a spinal fixation system.
- Type of Ground Truth (7): Not applicable. The "ground truth" for this device is its mechanical integrity and ability to perform its intended structural support function, verified by engineering and material standards, not by clinical pathology or outcomes in a study for this submission.
- Sample Size for Training Set (8): No training set as this is not an AI/ML device requiring training data.
- Ground Truth for Training Set (9): Not applicable, as there's no training set.
Summary of what is present and relevant to the 510(k) in relation to 'testing':
The submission indicates that the predicate device (Novel™ Spinal System) underwent mechanical testing, including:
- Static Compression Bending
- Static Tension Bending
- Static Torsional
- Dynamic Compression Fatigue Testing
All these tests were performed per ASTM F 1717-04.
The subject device (Novel III™ Spinal Fixation and Adjustable Bridge System) "contains dimensionally modified components (not worst case) and therefore not subject to ASTM F 1717-04 additional testing." This implies that because the modifications were not considered "worst case" in terms of mechanical stress, the new device was deemed substantially equivalent to the predicate without needing to repeat all the same mechanical tests. The acceptance criteria for the subject device are therefore implicitly:
- Substantial Equivalence: The modified components do not negatively impact the mechanical performance already established for the predicate device.
- Compliance with ASTM F 1717-04 (by proxy via predicate): The predicate device met these standards, and the modifications to the subject device are not considered to compromise that compliance.
In essence, the "study" proving the device meets acceptance criteria is the mechanical testing of the predicate device against ASTM F 1717-04, and the subsequent engineering analysis that concluded the modifications in the Novel III™ system did not require new, full-scale mechanical testing due to their non-worst-case nature.
§ 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.