(26 days)
The ALINE™ Anterior Cervical Plating System is designed to provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures) and tumors. DDD is defined as neck and/or arm pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device is intended for anterior cervical intervertebral body screw fixation only.
The ALINE TM Anterior Cervical Plating System is utilized to provide post-operative stabilization until fusion of the cervical spine has eventuated. Essentially, the plating system acts as an internal splint that carries a portion of the load until the process of healing is complete. The Aline Cervical Plating system consists of Ti-13-13 plates, bone screws, and locking screws.
The provided text describes a medical device, the ALINE™ Anterior Cervical Plating System, and its clearance through the FDA's 510(k) process. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies of the kind requested in your prompt.
The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria as one would find for a de novo submission or a product requiring clinical trials for efficacy.
Therefore, I cannot fulfill your request for the specific details outlined, as a detailed study report with performance metrics is not present in the provided text.
The information I can extract and convey from the provided text is as follows:
- Device Name: ALINE™ Anterior Cervical Plating System
- Intended Use: To provide temporary stability to the cervical spine during the development of a solid spinal fusion in patients with degenerative disc disease (DDD), trauma (including fractures), and tumors. Intended for anterior cervical intervertebral body screw fixation only.
- Predicate Device: ALINE™ Anterior Cervical Plating System (K943523) – This indicates that the current device (K984342) is considered substantially equivalent to a previously cleared device.
- Regulatory Clearance: FDA 510(k) clearance (K984342) received on December 30, 1998, based on substantial equivalence to the predicate device.
To answer your request, if this were a study report, the following sections would typically contain the requested information:
- A table of acceptance criteria and the reported device performance: This would be found in the results section of a clinical or non-clinical study.
- Sample sized used for the test set and the data provenance: This would be in the methods section of a study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would be in the methods section, particularly for ground truth establishment.
- Adjudication method for the test set: Details on how discrepancies were resolved would be in the methods section.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: This would be explicitly stated as a study type, with an effect size reported in the results.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This would be a specific study design and reported in the methods/results.
- The type of ground truth used: This would be specified in the methods section (e.g., pathology, clinical follow-up, expert consensus).
- The sample size for the training set: This would be detailed in the methods for algorithm development.
- How the ground truth for the training set was established: This would be described in the methods for algorithm development.
Since none of this information is in the provided document, I cannot fill in the table or answer the specific questions about performance studies. The document only confirms that the device was deemed "substantially equivalent" to a previously cleared device, which typically relies on demonstrating similar technological characteristics and intended use, often without requiring new clinical performance studies for 510(k) clearance.
§ 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.