(56 days)
The FORTEZZA Spinal Stabilization System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion.
In addition, when used as a pedicle screw fixation system, the FORTEZZA Spinal Stabilization System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the FORTEZZA Spinal Stabilization System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The FORTEZZA Spinal Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.
The FORTEZZA Spine Stabilization System consists of a variety of shapes and sizes of screws and 5.5 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy. Components of the system include straight and pre-bent rods, multi-axial screw.
This document is a 510(k) summary for the FORTEZZA Spinal Stabilization System, a medical device. It does not describe any clinical studies involving humans or AI. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical, bench testing.
Therefore, the requested information elements related to clinical studies, AI performance, ground truth, experts, and sample sizes for training/test sets are not applicable to this document.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM F1717-14 and FDA Guidance) | Reported Device Performance |
|---|---|
| Static compression bending performance | Meets or exceeds predicate device performance |
| Static torsion performance | Meets or exceeds predicate device performance |
| Fatigue compression bending performance | Meets or exceeds predicate device performance |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a number of devices/tests, but implicitly refers to the number of samples required by ASTM F1717-14 for mechanical testing.
- Data Provenance: Not applicable for mechanical bench testing. The data is generated in a laboratory setting through controlled experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No human experts were involved in establishing "ground truth" for these mechanical performance tests. The ground truth is determined by the physical properties and mechanical behavior of the device components under standardized test conditions specified by ASTM F1717-14.
4. Adjudication method for the test set
- Not Applicable. There is no adjudication method in the context of mechanical bench testing. Performance is measured against pre-defined engineering and material standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This document describes a medical device for spinal stabilization, not an AI-powered diagnostic or interpretive tool. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This document describes a physical medical device, not a software algorithm.
7. The type of ground truth used
- The "ground truth" for the performance testing is based on engineering and material science standards and measurements. Specifically, the device's mechanical properties (static compression bending, static torsion, fatigue compression bending) are measured and compared against the properties of a predicate device, as required by ASTM F1717-14 and FDA guidance.
8. The sample size for the training set
- Not Applicable. There is no training set in the context of this type of medical device submission (mechanical testing for substantial equivalence).
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth for a training set.
§ 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.