(63 days)
The Athena II 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, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena II Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
The Athena II 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 II Cervical Plate System are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. The Athena II Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.
The provided text is a 510(k) summary for the Athena II Cervical Plate System. It describes the device, its indications for use, and a comparison to predicate devices, including performance testing. However, this document does not describe a study involving an algorithm's performance, human reader studies, or the establishment of ground truth in a medical imaging context.
The information provided pertains to a mechanical medical device (a cervical plate system) and its structural performance, not an AI/ML-driven diagnostic or assistive device. Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
The document discusses pre-clinical testing for the Athena II Cervical Plate System, which focuses on the mechanical integrity and performance of the physical implant itself.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that pre-clinical testing was performed per ASTM F1717-13. The reported performance is a comparison to predicate devices.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression Bending | Equivalence to predicate devices (ASTM F1717-13) | Substantially equivalent to predicates |
| Static Torsion | Equivalence to predicate devices (ASTM F1717-13) | Substantially equivalent to predicates |
| Static Tension | Equivalence to predicate devices (ASTM F1717-13) | Substantially equivalent to predicates |
| Dynamic Compression Bending to 5MM cycles | Equivalence to predicate devices (ASTM F1717-13) | Substantially equivalent to predicates |
| Note: The specific numerical acceptance criteria from ASTM F1717-13 itself are not detailed in this summary, but the general principle is "substantial equivalence" to the predicates based on this standard. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not a study of an AI/ML device using a test set of medical data. The testing involves mechanical bench testing of physical medical devices. The "test set" would refer to the number of physical samples tested, which is not specified but is typically much smaller than for an AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of expert review of medical images or clinical outcomes, is not relevant to the mechanical testing of a cervical plate.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in expert interpretations of medical data, which is not what this document describes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is not an MRMC study. It is mechanical testing of a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices and the physical properties determined through the tests (e.g., load-bearing capacity, fatigue resistance). This is established via standardized testing protocols (ASTM F1717-13).
8. The Sample Size for the Training Set:
Not applicable. There is no training set for an AI/ML algorithm in this document.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for an AI/ML algorithm in this document.
In summary: The provided document is a 510(k) clearance summary for a spinal implant, focusing on its mechanical pre-clinical performance testing against predicate devices. It does not contain the type of information requested about AI/ML device studies or human reader performance.
§ 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.