CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)

• K Number: K963899
• Device Name: CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
• Manufacturer: EXMOOR PLASTICS LTD.
• Date Cleared: 1997-08-22 ( 329 days)
• Product Code: ETA
• Regulation Number: 874.3495
• Type: Traditional
• Panel: Ear Nose & Throat
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This product may be used for any defect in the ossicular chain of the middle ear, injury or congenital malformation.

Device Description

CAUSSE UNIVERSAL HA PROSTHESIS (formerly 'Causse Universal Ossicular Replacement Prosthesis)

AI/ML Overview

This is an FDA Premarket Notification (510(k)) K963899 for a medical device called the "Causse Universal Ossicular Replacement Prosthesis," later renamed "Causse Universal HA Prosthesis." The document is an approval letter from the FDA dated August 22, 1997, confirming that the device is substantially equivalent to legally marketed predicate devices.

The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The document is a regulatory approval letter, not a technical report detailing the device's validation studies.

Therefore, I cannot fulfill your request for that specific information based on the provided text.

Regulation Number and Section

§ 874.3495 Total ossicular replacement prosthesis.

(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.