(80 days)
The PERPOS™ FCD-2 System isindicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by rediographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.
The intended use of the PERPOS™ FCD-2 Anchor and Stabilizer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS™ FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The PERPOS FCD-2 is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOS™ FCD-2 Anchor and Stabilizer.
The PERPOS™ FCD-2 Single Use System consists of two each of a double-helix facet screw with a compression-locking collar, retaining ring and a self-retaining polymer washer packaged in a single use tray with the associated manual instruments. Modifications from the predicate device include changes to the washer configuration, instrumentation and packaging.
The provided text describes a 510(k) submission for a medical device (PERPOS™ FCD-2 System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance metrics.
Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document explicitly states:
"Documentation was provided to demonstrate that the PERPOS™ FCD-2 System is identical or similar to the predicate device in technological characteristics. The PERPOS™ FCD-2 System is identical to the predicate device in intended use and identical or substantially equivalent to the predicate device in materials, design and technological characteristics."
And "Risk analysis was conducted on the impact of the changes and appropriate design verification and validation was conducted under the company's design controls."
This indicates that the submission relies on demonstrating similarity to an already approved device and internal design controls, rather than a clinical study with specific performance metrics and acceptance criteria for the new device.
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