(189 days)
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The Delphos Implants Rigid Fixation System implants are intended for single use only.
The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture.
The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology.
The provided text describes a 510(k) summary for the "Delphos Implants Rigid Fixation System," a bone plate device. This summary focuses on establishing substantial equivalence to predicate devices rather than proving a medical device's performance through clinical studies or AI-driven acceptance criteria.
The information you're requesting (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is typically found in submissions for novel devices or AI/machine learning-based medical devices that require rigorous performance evaluation against established clinical endpoints or human performance.
This document does NOT contain the information needed to answer your questions about acceptance criteria performance, study design (sample size, provenance, experts, adjudication, MRMC, standalone), or training set details.
The document details:
- Device Name: Delphos Implants Rigid Fixation System
- Regulation Number: 21 CFR 872.4760 (Bone Plate)
- Regulatory Class: Class II
- Product Code: JEY
- Indications for Use: Fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction.
- Key Comparison: Substantial equivalence to predicate devices (Osteomed Modular Locking Fixation System, LeForte System Bone Plate & Screw, Biomet Microfixation Facial Plating System, CranioMaxillofacial Fixation (CMF) System - CMF Visionare).
- Performance Data: Primarily mechanical testing (ASTM F382 for plates, ASTM F543 for screws) to demonstrate comparable physical properties to predicate devices. Biocompatibility testing was also conducted according to ISO standards.
- Clinical Data: Explicitly states, "No clinical data were included in this submission."
Therefore, I cannot provide the requested information from this document. The provided text is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with performance metrics against acceptance criteria for a novel device or an AI/ML algorithm.
§ 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.