Search Results

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

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 < 10^-6).
• Packaging Integrity: Packaging must maintain device integrity and sterility.
• MRI Compatibility: The device must be MRI Conditional at 1.5T, 3.0T, and 7.0T.
• Mechanical Integrity: The device must meet design and performance requirements for mechanical strength.
• Adverse Event Rates: Low rates of device dislocations/extrusions and revision surgeries, and stable bone conduction thresholds.

Study Details

The study conducted to demonstrate equivalence and meet the acceptance criteria was a Post-Market Clinical Follow-Up (PMCF) investigation conducted in Europe.

1. Sample size used for the test set and the data provenance:

• Audiological Outcomes: 92 patients (47 female, 45 male)
• Adverse Events: 102 patients (52 female, 50 male)
• Data Provenance: Europe, retrospective, single-subjects repeated measures (each subject served as his or her own control).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. However, given the nature of the study (clinical follow-up with audiological outcomes), it is implied that qualified audiologists and ENT surgeons were involved in collecting and interpreting the audiological data and clinical observations. The document mentions the target user is "qualified ENT surgeons only."

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not describe a specific adjudication method for the test set. It appears clinical data was collected directly from patient outcomes.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical implant (total ossicular replacement prosthesis) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the clinical effectiveness aspect (audiological outcomes) was outcomes data from patients who received the implant. This included:

• Postoperative PTA4 ABG measurements.
• Mean BC-PTA4 pre/post-surgery.
• Incidence of BC-PTA4 deterioration.
• Observation of adverse events (revision surgeries, dislocations/extrusions).

7. The sample size for the training set:

Not applicable. This is a physical medical device and does not involve AI algorithms that require a training set.

8. How the ground truth for the training set was established:

Not applicable. As a physical medical device, there is no training set or corresponding ground truth establishment process in the context of machine learning.

Ask a specific question about this device