(62 days)
The Endius Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Endius Cervical Plate System is a set of implants designed to be implanted via an anterior approach to the cervical spine. The system includes various plates and screws manufactured from Titanium. The material used in the manufacture of the components in the Endius Cervical System meets ASTM F136 for Ti 6A1-4VELI.
The provided text describes a 510(k) summary for the Endius Cervical Plate System, focusing on its substantial equivalence to a predicate device rather than presenting a study with detailed performance metrics against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of features and adherence to recognized standards for mechanical testing.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define explicit performance acceptance criteria in terms of clinical outcomes or specific quantitative measures for the device's function in a biological system. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device and meeting a standard for biomechanical testing.
| Acceptance Criteria (Inferred from Substantial Equivalence and ASTM Standard) | Reported Device Performance (Summary from Submission) |
|---|---|
| Product Components Match Predicate | Plates of various lengths, 4mm screws, 4.3mm revision screws. (Identical to predicate) |
| Indications for Use Match Predicate | Intended for anterior interbody screw fixation of cervical spine for temporary stabilization during fusion in patients with degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions. (Identical to predicate) |
| Materials Match Predicate | Titanium (Meets ASTM F136 for Ti 6A1-4VELI). (Identical to predicate) |
| Product Labeling Matches Predicate | Instructions for use and box labeling including all necessary warning statements. (Identical to predicate) |
| Packaging/Sterilization Matches Predicate | Non-sterile, single use only. (Identical to predicate) |
| Biomechanical Performance Meets Standard | Meets ASTM F1717 (Standard Specification for Implantable Bar, Plate, and Screw Devices for Internal Fixation Applications). |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a test set in the context of clinical data or human subjects. The "testing" mentioned refers to biomechanical testing of the device itself.
- Sample Size: Not applicable in terms of clinical subjects. For biomechanical testing (ASTM F1717), the standard defines the number of samples required for various tests; however, the specific number of test articles (plates, screws, constructs) used by Endius is not specified in this summary.
- Data Provenance: Not applicable for clinical data. The biomechanical testing would have been conducted in a lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This was a 510(k) submission based on substantial equivalence and biomechanical testing, not a clinical study requiring expert consensus for ground truth on patient outcomes or diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission concerns a spinal implant, not an AI or imaging diagnostic device. No MRMC study was conducted or is relevant to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a medical implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Predicate Device Comparison: The legal marketing status and safety/effectiveness history of the Window Dynamic Plate System (another Endius product) serves as a "ground truth" for substantial equivalence.
- ASTM F1717 Standard: Adherence to this recognized consensus standard for biomechanical testing of spinal implants (specifically "Implantable Bar, Plate, and Screw Devices for Internal Fixation Applications") provides the "ground truth" for the mechanical integrity and performance of the device under simulated physiological conditions.
8. Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The design and testing of the device are based on engineering principles, material science, and established biomechanical standards, not on learning from a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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.