(25 days)
The KURZ Aerial implants are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device and the favorable biocompatible characteristics of gold and titanium.
Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate.
The Aerial Total Prosthesis is intended for bridging a complete auditory ossicle defect.
The prosthesis is placed on the basis of the stapedis and the defect is bridged as far as the ear drum or up to the manubrium mallei.
The implant consists of a golden wire rectangle with a structured outer surface and a stem which is available in various lengths. It ends in a 'bell' with two slits.
The implant consists of an extremely thin mesh plate made of gold and a thin shaft, which is available in different lengths. It has a split piston at the end.
The implant consists of a titanium mesh plate that is textured on the surface that makes contact with the tympanum and a shaft that is available in various lengths.
The prosthesis consists of a titanium mesh plate that is connected eccentrically with a shaft available in various lengths. A hollow piston, open at the bottom, the inside of which is also textured, is located at the end of the shaft.
The device is a single patient use only implant. It comes in an individual sterile package in a sealed carton.
The provided 510(k) summary for the Heinz Kurz GmbH Aerial Prosthesis (K972585) does not contain the information requested regarding acceptance criteria and a study to prove the device meets those criteria.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices. In the context of 510(k) submissions, manufacturers typically compare their new device to legally marketed predicate devices to show that it is as safe and effective. This process generally does not involve establishing new acceptance criteria or conducting extensive effectiveness studies in the same way a Premarket Approval (PMA) application would.
Here's what can be inferred from the document regarding the device's assessment:
- Acceptance Criteria and Reported Device Performance: This information is not present. The document states, "There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants," implying that their safety and effectiveness are considered comparable to the predicate devices.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): None of these details are provided as there is no description of a specific study to establish acceptance criteria or device performance metrics. The submission is based on the premise that the device's technological characteristics and intended use are similar enough to predicate devices that new, extensive clinical studies are not required to demonstrate safety and effectiveness.
- Training Set Information: Not applicable, as there's no machine learning or AI component described or evaluated.
Explanation of the 510(k) Process as it relates to this document:
The 510(k) pathway is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). This is often achieved by demonstrating "substantial equivalence," meaning that the new device has the same intended use and the same technological characteristics as the predicate device, or, if there are differences, that those differences do not raise new questions of safety or effectiveness.
In this specific 510(k) summary, the manufacturer asserts:
- Identification of Predicate Devices: The KURZ Aerial total ossicular implants are substantially equivalent to total ossicular devices of Smith & Nephew Richards and Xomed (with Ionos).
- Description of Device: Details on the materials (gold, titanium) and design (wire rectangle, mesh plate, shaft, bell, piston) for different models (Standard, Dresden, Düsseldorf, Tübingen).
- Intended Use: Reconstruction of the ossicular chain to facilitate sound energy conduction.
- Technological Characteristics: Implants can be bent and shaped but hold their shape after placement.
- Safety and Effectiveness: "The KURZ Aerial total ossicular replacements have the same intended use as predicate devices. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants."
Conclusion:
The provided K972585 document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study proving those criteria are met for a novel device. Therefore, the specific information requested in your prompt (acceptance criteria table, study details, sample sizes, ground truth, expert qualifications, etc.) is not contained within this submission.
§ 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.