(82 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. Vertebral staples are limited to use with 5.5mm and larger monoaxial screws only.
- The ZODIAC™ Spinal Fixation 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). - The ZODIAC™ Spinal Fixation 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™ Spinal Fixation 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 (L3-S1) and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. - The ZODIAC™ 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 scolliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis). - When used as an anterior fixation system, the ZODIAC Spinal Fixation System intended for degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumors and/or failed previous fusion.
The ZODIAC™ Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium allov or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.
The provided document describes a medical device, the ZODIAC™ Spinal Fixation System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit performance against predefined acceptance criteria from a clinical study.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable as this submission is for a spinal fixation system, which typically involves mechanical and biocompatibility testing, not diagnostic performance studies with human readers.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What would normally be tested clinically) | Reported Device Performance (as per 510(k)) |
|---|---|
| Not specified (clinical performance is not the primary focus of this 510(k) submission type) | Mechanical and dynamic testing was performed. |
| e.g., Clinical success rates, complication rates, fusion rates (for clinical trials) | Test results demonstrated that the ZODIAC™ Spinal Fixation System is at least comparable to, if not better than those of the predicate devices. |
| Substantial Equivalence to Predicate Devices | Documentation was provided that demonstrates that the ZODIAC™ Spinal Fixation System is substantially equivalent to other pedicle screw systems currently on the market. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for a 510(k) for a spinal fixation system that relies on mechanical testing and substantial equivalence. The "test set" in this context refers to the samples used in mechanical and dynamic testing of the device hardware, not a clinical data set. The document does not specify the number of individual implants or components tested.
- Data Provenance: The testing was presumably conducted by the manufacturer, Alphatec Manufacturing, Inc., or a contracted lab. The document does not specify the country of origin of this testing data. It is a retrospective summary of testing performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a hardware device (spinal fixation system), not a diagnostic algorithm where expert ground truth is established for a test set. The "ground truth" here would be the physical properties derived from mechanical testing specifications and comparison to predicate devices, which are assessed by engineers and regulatory bodies.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human readers or expert consensus involved in establishing a ground truth for a diagnostic test set in this context, there is no adjudication method.
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
- No, an MRMC study was NOT done. This device is a spinal fixation hardware system, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was NOT done. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Engineering specifications and performance of predicate devices. For a device like the ZODIAC™ Spinal Fixation System, the "ground truth" for its performance evaluation in a 510(k) is based on:
- Mechanical and Dynamic Testing Standards: The device's physical properties (e.g., strength, fatigue resistance) are tested against established engineering standards and specifications.
- Predicate Device Performance: The central claim of a 510(k) is substantial equivalence. The "ground truth" for this claim is a comparison of the device's design, materials, and performance (including mechanical testing) to that of legally marketed predicate devices, which are already considered safe and effective for their intended use.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware device, not an AI/ML algorithm. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this device, there is no ground truth established for it.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.