(63 days)
The DeRoyal Industries. Inc. Multider "Plus Oel in chronic, non-healing wounds, ulcers, and over burns to provide a procecive film and a moist wound environment conducive to healing.
The DeRoy I Industrics, In Multidex "Plus Gel is the same as Multidex" Plus Powder in the same manner as Multider " Plus Powder, it is used in case of thoric, nombaling would, ut car, and over burn as a protection in the same in the same prodicate devices, the plater, in the strong nonealing would , ulces, ac over buns as a pocecive film. Like that for the devices is used o cover wouds and a provide a moist the basis for the device is a bot the proces and in provide a most environment conductive on healing concept of the bacesing be the form the basis for the decise in that the Device DesignMaterials UsedPhysical Propries: The proposed DeRoyal Industries, Inc. Multics I Plus Gr. Includes the same materials as the same of the country stour riop. The proposed Dekoyal Industries, Inc. Multies." Plus Colincludes the same Multidex Plus Powder. The concept of use is that it can be easi
This document is a 510(k) summary for the DeRoyal Industries, Inc. MULTIDEX® PLUS GEL. It describes the device and its intended use, and compares it to legally marketed predicate devices.
However, it does not contain any information about a study that tests specific acceptance criteria and reports device performance against those criteria.
The document states that "The DeRoyal Industries, Inc. Multidex® Plus Gel is the same as Multidex® Plus Powder... Like its predicate devices, the Multidex® Plus Gel is used to cover wounds and to provide a moist environment conducive to healing." It highlights the difference in form (gel vs. powder) for easier application and flexibility but doesn't present data from a clinical or performance study about this.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence based on materials, intended use, and existing knowledge of a key ingredient (glycerin), rather than providing results from a specific performance study.
N/A