(106 days)
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.
- The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine,
b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
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The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis).
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In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving only autogenous bone graft
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
- The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
This document describes a 510(k) submission for the Zodiac® Polyaxial Spinal Fixation System, which is a medical device. As such, the "acceptance criteria" and "device performance" are not related to diagnostic accuracy or clinical outcomes as would be the case for AI/ML devices. Instead, they refer to the device's mechanical properties and its substantial equivalence to previously approved devices. The "study" refers to mechanical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical and dynamic performance per recognized consensus standards and FDA guidance for spinal systems. | "Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use." |
| Satisfaction of requirements for posterior lumbar fixation. | "This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation." |
| Substantial equivalence to predicate Zodiac® Polyaxial Spinal Fixation System devices in terms of general design, intended use, and technological characteristics. | "The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic device that uses data for testing. The "test set" would refer to the physical samples of the device undergoing mechanical testing. The document states "Mechanical and dynamic testing was performed," implying laboratory testing of device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. For mechanical devices, "ground truth" is established by engineering specifications, material properties, and standardized testing protocols, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used for resolving discrepancies in expert interpretations of data, which is not relevant for mechanical testing of a spinal fixation system.
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
This information is not applicable. This is a physical spinal fixation device, not an AI/ML diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical spinal fixation device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For mechanical devices, the "ground truth" is typically derived from engineering specifications, material science principles, and established international and national consensus standards (e.g., ASTM, ISO standards for spinal implants) that define performance requirements for strength, fatigue life, and other mechanical properties. The document explicitly states, "Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff," indicating adherence to these established engineering "ground truths."
8. The sample size for the training set
This information is not applicable. This is a physical medical device. "Training set" refers to data used to train AI/ML models, which is not relevant here.
9. How the ground truth for the training set was established
This information is not applicable. As no training set is used for a mechanical device.
Summary of the Study:
The study described is a series of mechanical and dynamic performance tests conducted on the Zodiac® Polyaxial Spinal Fixation System and its additional components.
- Objective: To provide reasonable assurance of the safety and effectiveness of the device for its intended use and to demonstrate substantial equivalence to predicate devices.
- Methodology: Testing was performed according to "recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff." This involved evaluating both "static and fatigue performance characteristics."
- Results: The testing "clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation." Furthermore, the "mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device."
- Conclusion: The tests confirmed that the device's mechanical properties were comparable to previously approved predicate devices, supporting its substantial equivalence claim to the FDA.
§ 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.