(106 days)
The indications for use of the MODUS® 2.5 Reconstruction Set include reconstruction surgery, including bone grafting and bridging defects in the mandible after tumor resection or severe infection. It is also indicated for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.
The MODUS® 2.5 Mandibular Reconstruction Set is a complete fracture fixation system that includes titanium plates, titanium screws, templates, and accompanying instruments and accessories.
This document is a 510(k) summary for the MODUS® 2.5 Mandibular Reconstruction Set, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your bullet points (acceptance criteria, study details, sample sizes, expert involvement, MRMC study, standalone performance, ground truth, training set) is typically not found in a 510(k) submission for this type of device (a Class II orthopedic implant).
Instead, 510(k) summaries for devices like this primarily focus on:
- Description of the Device: What it is made of, its components, and how it works.
- Intended Use: The medical conditions it is meant to treat.
- Comparison to Predicate Devices: How it is similar and different from previously cleared devices, and why these differences do not raise new questions of safety and effectiveness.
- Performance Data: Often non-clinical data (e.g., mechanical testing, materials testing) to demonstrate that the new device performs as intended and is equivalent to predicate devices. For orthopedic implants, this often involves fatigue testing, strength testing, and biocompatibility testing.
There is no information within the provided text about acceptance criteria, clinical study results, sample sizes for test or training sets, ground truth establishment, or expert reviews as these would be found in a clinical trial report. The document states that the device is "substantially equivalent" to predicate devices based on its design and intended use.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is essentially a regulatory clearance letter, not a detailed clinical study report.
§ 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.