(218 days)
The Maxima™ Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Maxima™ Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also pre-assembled to the main plate and designed to assemble the sub-plate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. Screws can be inserted in the center hole of Main Plate - S type. Main Plate - S type are offered in no hole, one hole, two hole, three hole and ranges from 24mm to 108mm. Screws are available in lengths from 10mm to 20mm in 1mm increments. The screws have either a 3,5mm or 4.0mm diameter. Variable screw and Semi-fixed screw are provided. Variable screw provides more rotational and translational degree of freedom than Semi-Fixed screws.
The Maxima™ Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device K994239, K030327) | Reported Device Performance (Maxima™ Anterior Cervical Plate System) |
|---|---|
| Mechanical performance according to ASTM F1717-01 | Demonstrated substantial equivalence to ZEPHIR™ Anterior Cervical Plate System in mechanical testing per ASTM F1717-01. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The study relies on mechanical testing according to a standard. Therefore, there's no information about:
- Sample size for the test set: Not applicable in the context of this submission.
- Data provenance: Not applicable. The data provenance is mechanical testing in a lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for this device's performance is established by adherence to a recognized mechanical testing standard (ASTM F1717-01), not human expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation method is based on a mechanical testing standard, not clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is for comparing performance with and without an AI system, which is not relevant for this medical device submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating device performance is based on mechanical testing standards (ASTM F1717-01). The objective of the study was to show that the new device's mechanical performance is equivalent to that of existing, legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant; there is no "training set" in the context of machine learning or AI. The development process would involve engineering design and iterative physical testing, not data-driven training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.