(85 days)
The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Fracture;
d) Spinal Stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
The CETRA Anterior Cervical Plate System consists of an assortment of non- sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine.
This document describes a 510(k) premarket notification for a medical device called the "CETRA Anterior Cervical Plate System". The context of the document is a submission to the FDA (Food and Drug Administration) for substantial equivalence to existing predicate devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria and device performance are demonstrated through non-clinical mechanical testing rather than clinical performance metrics. The core argument for substantial equivalence relies on the device's technological characteristics being similar to already approved predicate devices.
| Acceptance Criteria (Stated Goal) | Reported Device Performance (Summary) |
|---|---|
| Meet ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. | Mechanical testing conducted in accordance to ASTM F1717, including: |
- Static Axial Compression Test
- Dynamic Axial Compression Test
- Static Torsion Test |
| Ability of the locking mechanism to retain screws after implantation. | Screw push-out test conducted, which served to mechanically evaluate the CETRA Anterior Cervical Plate System locking mechanism's ability to retain screws after being implanted. |
The document concludes that the "new CETRA Anterior Cervical Plate System has the same intended use, the same indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate Hallmark Anterior Cervical Plate System (K100614) and the additional predicate devices..." This implies that the performance in these mechanical tests was found to be comparable and acceptable, establishing substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each mechanical test performed (e.g., number of plates or screws tested). It simply states that "Mechanical testing... were conducted" and "Additional mechanical testing included a screw push-out test."
Data provenance: This is a pre-market notification for a new device. The data is non-clinical (mechanical testing), not human clinical trial data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't directly apply in the usual sense of clinical studies. The testing was conducted by the device manufacturer, Orthofix Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this document. The "ground truth" for mechanical testing is based on established engineering standards (ASTM F1717) and physical measurements, not expert human interpretation (like in medical imaging). There's no mention of experts establishing ground truth in the way it would be done for, say, a diagnostic AI.
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for clinical studies where human interpretation or consensus is required (e.g., in MRMC studies). For mechanical testing, the results are quantitative and objective based on defined standards.
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
Not applicable. This device is a spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating the device's performance is based on established engineering standards and physical durability/functionality measurements as defined by ASTM F1717 and the screw push-out test. This is an objective, quantitative ground truth for mechanical properties.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for physical product evaluation in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for this physical 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.