(546 days)
The Anterior Dynamized system is intended for use in anterior instrumentation and afusion for for kyphotic decompression deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.
The Anterior Dynamized system is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The Anterior Dynamized construct allows continual compression of the bone graft while avoiding hyperextension type forces on the The components of the Anterior Dynamized system construct. have been designed with anatomic limitations in mind.
The provided text is a 510(k) summary for a medical device called the "ALC Dynamized Fixation System." It describes the device, its components, indications for use, and a brief mention of non-clinical performance data.
Crucially, the document explicitly states "PERFORMANCE DATA: Non-Clinical" and then describes static and dynamic mechanical testing. There is no mention of clinical studies, human performance data, acceptance criteria related to a specific clinical outcome, or any of the detailed information requested in your prompt regarding clinical performance, ground truth, expert involvement, or sample sizes related to patient data.
Therefore, I cannot provide the requested information from the given text as it only discusses mechanical testing, not clinical performance.
Here's a breakdown of why each requested point cannot be answered based on the provided input:
- A table of acceptance criteria and the reported device performance: The document only mentions mechanical tests (static compression bending, torsion, dynamic bending compression) to characterize properties like stiffness, strength, maximum applied moment, and fatigue life. It does not state specific acceptance criteria for these mechanical properties nor does it report the numerical performance values against any such criteria. It certainly doesn't provide clinical acceptance criteria or performance data.
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical samples of the device, not a set of patient data. The document does not specify the number of constructs or components tested for the non-clinical evaluations.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies, involves expert assessment of patient data. This document describes mechanical testing, which does not involve human experts establishing a "ground truth" in that sense.
- Adjudication method for the test set: Not applicable. Adjudication methods are for reconciling differences in expert opinions on clinical data.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is a clinical study involving human readers evaluating cases. The provided data is for non-clinical, mechanical testing.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is for a physical medical device, not a software algorithm.
- The type of ground truth used: Not applicable for mechanical testing.
- The sample size for the training set: Not applicable. This refers to the training of an algorithm, which is not the subject of this document.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary focuses solely on the description of a spinal fixation device and its non-clinical mechanical performance testing. It does not contain any information regarding clinical studies, patient data, or the clinical performance metrics you are asking about.
§ 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.