(32 days)
The Athena III 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 a solid spinal fusion 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. The Athena III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
The Athena III Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena III Cervical Plate System are manufactured from titanium alloy (Ti-6AI-V), as per ASTM F136. The system consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.
This document is a 510(k) premarket notification for the Athena III Cervical Plate System. It describes a medical device, specifically a spinal implant, and seeks to demonstrate its substantial equivalence to a previously cleared predicate device (Athena II Cervical Plate System).
The information provided does not describe an AI/ML medical device, nor does it detail acceptance criteria related to software performance, or a study involving human readers or ground truth determination as typically found in AI/ML performance evaluations. Instead, it focuses on the mechanical performance of a physical implant.
Therefore, I cannot extract the requested information using the prompt's categories, as they are tailored for AI/ML device evaluations.
Here's a breakdown of what is provided regarding acceptance criteria and the study, adapted to the context of this physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (for physical device) | Reported Device Performance |
|---|---|
| Mechanical Strength & Safety (Static Compression Bending) | Met acceptance criteria (further details in submission, not provided) |
| Mechanical Strength & Safety (Static Torsion) | Met acceptance criteria (further details in submission, not provided) |
| Mechanical Strength & Safety (Static Tension) | Met acceptance criteria (further details in submission, not provided) |
| Mechanical Strength & Safety (Dynamic Compression Bending) | Met acceptance criteria (further details in submission, not provided) |
| Material Composition | Titanium Alloy (Ti-6Al-4V) per ASTM F136 (Equivalent to predicate) |
| Manufacturing Processes | Equivalent to predicate |
| Design Features/Dimensions | Comparable to predicate (modified screw and wing plate design, but overall comparable) |
| Post-Processing Procedures (Sterility, Shelf-Life) | Equivalent to predicate |
| Indications for Use | Equivalent to predicate (anterior interbody screw fixation of the cervical spine, C3-C7 levels, for various conditions) |
| Intended Use & Fundamental Scientific Technology | Same as predicate |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "a full suite of mechanical testing" but does not specify the sample size for the test articles (cervical plates and screws). The "data provenance" in this context would refer to the testing facility and conditions, which are not detailed here.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is not applicable as the evaluation is for mechanical performance of a physical device, not an AI/ML algorithm requiring expert-established ground truth.
4. Adjudication Method:
This is not applicable as the evaluation is for mechanical performance of a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable as the device is a physical spinal implant, not an AI/ML system evaluated with human readers.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the mechanical properties of the Athena III Cervical Plate System were tested independently. The study involved:
- Static compression bending
- Static torsion
- Static tension
- Dynamic compression bending
These tests were performed "as per ASTM F1717," which is a standard specification for spinal plate mechanical testing.
7. Type of Ground Truth Used:
In the context of a physical device, the "ground truth" is defined by established engineering standards and material properties. For this device, the relevant "ground truth" is adherence to:
- ASTM F136 (for titanium alloy material)
- ASTM F1717 (for mechanical testing methods and likely performance criteria thresholds)
- AMS 2487A (for anodization).
8. Sample Size for the Training Set:
This is not applicable as the device is a physical spinal implant and does not involve a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set for a physical device. The "ground truth" for developing and validating the device is based on mechanical engineering principles, material science, and established regulatory and industry standards for spinal implants.
§ 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.