FAICO CMF System

• K Number: K191997
• Device Name: FAICO CMF System
• Manufacturer: FAICO Medical LLC
• Date Cleared: 2020-04-22 ( 271 days)
• Product Code: JEY , DZL
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

FAICO CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:

1. Fractures
2. Osteotomies
3. Reconstructive procedures
4. Revision procedures where other treatments or devices have failed.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "FAICO CMF System." This document primarily focuses on regulatory approval based on substantial equivalence to existing devices and outlines the indications for use.

It does not contain information about acceptance criteria, specific device performance data, study designs (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set details for AI/algorithm-based devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval, not a scientific study report.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.