(445 days)
MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.
MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.
The provided text describes information about the MCI-Neuro Fixation System, a cranial fixation device. However, it does not contain the kind of detailed information about acceptance criteria, clinical study design, sample sizes, expert qualifications, or comparative effectiveness studies that your request asks for, especially concerning an AI/ML-driven device.
The document discusses:
- Regulatory Clearance (K212391): It's a 510(k) premarket notification for a Class II medical device.
- Device Description: The system consists of plates, screws, and meshes made from titanium.
- Predicate Device: K141911 - OPTIMUS NEURO SYSTEM.
- Performance Data: This section focuses on bench testing for physical and material properties (metallographic tests, cyclic polarization, cycle bend testing of plates, screw torsion yield test, pull-out testing, driving torque testing).
- Biocompatibility: Stated as supported by a reference device (K182758).
- Lack of Clinical Data: Explicitly states, "No clinical data were included in this submission."
Since this device is a physical fixation system and not an AI/ML driven diagnostic or prognostic tool, the concepts of human readers, AI assistance, ground truth establishment (beyond material specifications), training sets, and test sets in the context of diagnostic accuracy are not applicable to this document.
Therefore, I cannot provide a table of acceptance criteria and device performance, or details about clinical study design, sample sizes, expert qualifications, or adjudication methods as requested, because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence through material and mechanical bench testing.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).