(574 days)
The Poly/Platinum Pistons 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.
Poly/Platinum Pistons are implants for middle ear reconstruction. Available in a range of shaft diameters and lengths with loops for ossicular attachment. The device is a single patient use only implant, labeled as a restricted device for use only by a qualified health care professional and is individually sterile packaged, contained in a carton provided with an Important Product Information insert for the physician.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device (Poly/Platinum Pistons for middle ear reconstruction). It does not contain any information about acceptance criteria, device performance studies, or AI/ML components.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as none of that information is present in the provided text.
The document focuses on:
- Description of the device
- Identification of predicate devices for substantial equivalence
- Intended use
- Information bearing on safety and effectiveness (primarily by comparison to predicate devices and material differences)
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.