(47 days)
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:
- Spondylolisthesis
- Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
- Spondylolysis
- Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
- Trauma including spinal fractures and/or dislocations.
The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
This document is a 510(k) summary for the Dio Medical FaSet Fixation System, which is a medical device for spinal stabilization. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.
Based on the provided text, no study was conducted to prove the device meets acceptance criteria. The key statement is found under "Performance Data" in the 510(k) Summary:
"The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K180729. No testing is required."
This means that instead of conducting new performance studies, Dio Medical Corporation is asserting that their "FaSet Fixation System" is identical to a previously cleared device (Huvexel Co. Ltd. - FaSet Fixation System, K180729). Therefore, the device's acceptance criteria and the study proving it meets them would be found in the documentation for the predicate device (K180729), not in this specific submission (K222515).
Since the document explicitly states "No testing is required," I cannot provide answers to the questions you posed regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment based on this FDA 510(k) summary for K222515. The information you're requesting would have been part of the original K180729 submission made by Huvexel Co. Ltd.
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