(175 days)
The Cranial LOOP Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.
The Cranial LOOP Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use.
The provided text describes a 510(k) premarket notification for the "Cranial LOOP Cranial Bone Fixation System". It outlines the device's intended use, technological comparison to predicate devices, and a general statement about performance testing. However, it does not contain the specific details required to complete your request, particularly regarding acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or ground truth establishment.
The document states: "Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices." This is a summary statement, not the detailed study information you're asking for.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth determination based solely on the provided text.
The closest I can get to addressing your points, based on the limited information, is:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The document broadly implies that the device must "perform as intended" and be "substantially equivalent to the predicate devices."
- Reported Device Performance: Not explicitly quantified in the provided text. The document states that "Mechanical and various performance testing confirms the Cranial LOOP Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate devices."
The remaining points (2-9) require detailed study information that is not present in the provided 510(k) summary document. This document focuses on the regulatory submission, intended use, and substantial equivalence claim, rather than the raw data or detailed methodology of the performance studies.
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).