(76 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 as 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 tumor 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 autograft or allograft bone.
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.
The provided document describes the FDA 510(k) summary for the Zodiac® Polyaxial Spinal Fixation System. This is a medical device, and the acceptance criteria and study described are for mechanical performance testing rather than an AI/ML-driven device with performance metrics like sensitivity, specificity, or AUC.
Therefore, the requested AI-specific information (like sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, types of ground truth, etc.) is not applicable to this document.
Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended use | Mechanical and dynamic testing provides reasonable assurance of safety and effectiveness. |
| Compliance with recognized consensus standards | Performance testing was performed per recognized consensus standards and the guidance document, "Spinal System 510(k)s - Guidance for Industry and FDA Staff." |
| Adequacy of static performance characteristics | Testing documented static performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation. |
| Adequacy of fatigue performance characteristics | Testing documented fatigue performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation. |
| Substantial equivalence to predicate devices (mechanical performance) | 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 (K033090, K042673, K051286, K071890). |
2. Sample size used for the test set and the data provenance
- Not Applicable: This document focuses on mechanical testing of a physical medical device, not a data-driven AI/ML model where test set sample sizes and data provenance are relevant in the same way. The "test set" would refer to the physical devices or components subjected to mechanical stress. The document does not specify the number of devices tested, but it implies standard engineering testing procedures.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: "Ground truth" in the context of AI/ML refers to accurately labeled data. For mechanical testing, the "ground truth" is established by adherence to engineering standards and validated testing methodologies, not expert labeling. The experts involved would be engineers and regulatory bodies evaluating the test results against established safety and performance benchmarks.
4. Adjudication method for the test set
- Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert labeling for AI/ML ground truth. For mechanical testing, adherence to standards and test protocols is the primary method of validation.
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: MRMC studies are specific to AI/ML devices that impact human reader performance (e.g., diagnostic image interpretation). This document is about a physical spinal fixation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm on its own. The Zodiac® system is a physical implant, not an algorithm.
7. The type of ground truth used
- Engineering Standards and Test Protocols: For mechanical devices, the "ground truth" is defined by established engineering and regulatory performance standards (e.g., ISO, ASTM, or FDA-recognized consensus standards for spinal implants) and rigorous test protocols. The device's performance is compared against these predefined physical limits and requirements.
8. The sample size for the training set
- Not Applicable: "Training set" refers to data used to train an AI/ML model. This is a physical device, so no training set in that sense is involved.
9. How the ground truth for the training set was established
- Not Applicable: As there's no AI/ML training set, this question is irrelevant.
§ 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.