(86 days)
The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.
The Medicon 2.4 Mandibular Reconstruction Plating System includes titanium plates, titanium alloy Star*Grip screws, templates and accompanying instruments and accessories. Plates are 2.5 mm thick and include flat and preformed straight, angled, and full mandible configurations in lengths from 6 screw holes to 29 screw holes. Plates can accept 2.4 mm diameter locking screws or standard, non-locking 2.4 mm and 2.7 mm diameter bone screws. All screws are self-tapping. The 2.7 mm diameter screws can also be used as emergency screws.
The device is supplied non-sterile and must be sterilized prior to use. Moist heat sterilization is recommended.
Instruments and accessories available are: screwdrivers, screw holding forceps, twist drills, drill guide, cheek retractor with drill guide and trocar, plate bender, plate bending forceps, plate bending pliers, cutting lever, plate holding forceps, plate cutting forceps, tap, templates, storage and sterilization trays for implants and instruments.
This looks like documentation for a medical device (a mandibular reconstruction plating system) and not an AI/ML powered medical device. Therefore, the concepts of "acceptance criteria," "study," "sample size," "ground truth," "expert consensus," "training set," and "MRMC comparative effectiveness study" are not applicable in the context of AI/ML.
The provided document, K043297, is a 510(k) summary for the Medicon 2.4 Mandibular Reconstruction Plating System. It details the device description, intended use, and claims substantial equivalence to a previously cleared device (K951689). The FDA's review confirms this substantial equivalence.
Instead of an AI/ML study, the document focuses on regulatory compliance for a physical medical device. The "acceptance criteria" here would be established by the FDA's regulatory framework for medical devices, specifically demonstrating substantial equivalence to a predicate device.
Key points from the document relevant to its clearance:
- Device Description: The system includes titanium plates, titanium alloy Star*Grip screws, templates, and instruments. Plates are 2.5 mm thick, come in various configurations, and accept 2.4 mm or 2.7 mm screws. The device is supplied non-sterile.
- Intended Use: Used for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts in emergency and non-emergency situations.
- Substantial Equivalence: The Medicon 2.4 Mandibular Reconstruction Plating System is substantially equivalent to the Medicon Titanium Mandibular Reconstruction System (K951689) with modifications in plate material, thickness, screw holes, and expanded product lines for plates, screws, and instruments.
The FDA's letter (pages 2-3) confirms the substantial equivalence determination, allowing the device to be marketed. This regulatory process does not involve the type of acceptance criteria or studies typically associated with AI/ML device performance.
§ 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.