(268 days)
INTENDED USE: The passive middle ear implant - tympanoplasty total prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty total prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles totally. The tympanoplasty prosthesis is a medical device for single use delivered in sterile condition.
INDICATIONS: The tympanoplasty prosthesis is indicated to treat patients with: - congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma) - inadequate conductive hearing from previous middle ear surgery The total ossicular replacement prosthesis is indicated, if at least the stapes footplate is present and functional.
Tympanosplasty Sizers for total prosthesis INTENDED USE The tympanoplasty Sizers are intended to be used during a total ossicular replacement surgery to determine the required functional length of the MED-EL tympanoplasty prosthesis. The tympanoplasty Sizers are optional, single-use surgical tools for intraoperative transient use only and delivered in sterile condition. The Sizers for total prosthesis are intended to intraoperatively determine the distance between the footplate of the stapes and the tympanic membrane, thereby determining the required functional length of the MED-EL tympanoplasty prosthesis.
INDICATIONS The indications of the PMEI tympanoplasty total prostheses apply.
The MED-EL "Passive Middle Ear Implants" (PMEls) Tympanoplasty Total Prostheses are total ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. They are offered in different designs and fixed or adjustable functional length to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.
The provided document describes the safety and effectiveness of the MED-EL PMEI Tympanoplasty Total Prostheses. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance
The core acceptance criterion for the PMEI Tympanoplasty Total Prostheses is based on audiological outcomes, specifically the closure of the postoperative pure tone average (PTA4) air-bone gap (ABG).
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Target Outcome) | Reported Device Performance (Achieved Outcome) |
|---|---|
| Postoperative PTA4 ABG ≤ 20 dB in 48.3-57.4% of patients (state-of-the-art) | 53.3% of patients achieved a postoperative PTA4 ABG ≤ 20 dB |
Note regarding other criteria: While not explicitly stated as "acceptance criteria" with numerical targets, the document also implies the following are critical for acceptance and are demonstrated by the testing:
- Biocompatibility: The device should be biocompatible for its intended use.
- Sterility: The device must be sterile (SAL
§ 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.