(57 days)
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 screw indications are limited to the sacrum only.
- The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral 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). - The ZODIAC™ Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral 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).
- In addition, the ZODIAC™ Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. - The ZODIAC™ Polyaxial Pedicle Screw 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, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Adjustable bridges function as transverse connectors. Transverse connectors are used in spinal constructs to add torsional rigidity. The devices come in a range of sizes to accommodate the patient's anatomy. The transverse connectors will be used as part of the ZODIAC Polyaxial Pedicle Screw System. Components are manufactured from titenium alloy, Ti-6AI-4V ELI (ASTM F 136) or stainless steel (ASTM F138).
The provided text is a 510(k) summary for the ZODIAC™ Polyaxial Pedicle Screw System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on mechanical and dynamic testing. However, it does not contain the detailed information necessary to fully answer all the requested points about acceptance criteria and a study proving those criteria are met, particularly regarding AI performance or human reader improvements.
Here's an analysis based on the available information:
ZODIAC™ Polyaxial Pedicle Screw System - Acceptance Criteria and Supporting Study
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary implies that the acceptance criteria for this device are implicitly tied to the performance of its predicate devices. The "performance" being evaluated is mechanical and dynamic.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Mechanical strength and integrity comparable to predicate devices. | "The test results demonstrate that the mechanical performance of the ZODIAC™ Polyaxial Pedicle Terrew System is at least comparable to, if not better than, those of the predicate devices." |
| Dynamic Performance | Dynamic stability and durability comparable to predicate devices. | "The test results demonstrate that the mechanical performance of the ZODIAC™ Polyaxial Pedicle Terrew System is at least comparable to, if not better than, those of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document only states "Mechanical and dynamic testing of the transverse connectors as part of a spinal construct using the ZODIAC™ Polyaxial Pedicle Screw System was performed." It does not specify the sample size (e.g., number of constructs or individual components tested) nor the data provenance (e.g., country of origin, retrospective or prospective). This type of testing is typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study described is a mechanical and dynamic performance test, not a study involving human interpretation or expert ground truth as typically understood in AI/medical imaging contexts. The ground truth for such a study would be the physical properties and failure points determined by engineering standards and measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was a mechanical test, not one requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The provided text describes a mechanical and dynamic performance study, not an MRMC study comparing human readers with and without AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is a physical medical implant (pedicle screw system), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth for the mechanical and dynamic performance testing would be the quantitative data derived from the physical testing itself, measured against established engineering standards and specifications, and compared directly to the performance of the predicate devices. This is not "expert consensus, pathology, or outcomes data" in the typical clinical sense, but rather objective physical measurement data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for the mechanical testing described.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device and study.
§ 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.