Search Results

INTENDED USE. The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.

INDICATIONS: The stapesplasty prosthesis is indicated to treat patients with: - congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear - inadequate conductive hearing from previous stapes surgery

The MED-EL "Passive Middle Ear Implants" (PMEls) Stapesplasty Prostheses are partial ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. A partial (stapedotomy) or total opening of the footplate (stapedectomy) is required. The distal end (=piston) of the device is placed into the opening of the inner ear. The other end of the prosthesis (=Loop or Clip) is coupled to the long process of the incus or to the handle of the malleus. They are offered in different designs, functional lengths and/or piston diameters 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 text describes the acceptance criteria and a clinical study demonstrating the performance of the Med-El PMEI Stapesplasty Prosthesis.

Acceptance Criteria and Device Performance

The study concludes that the safety and effectiveness of the MED-EL PMEI Stapesplasty Prostheses are comparable to the current state of the art based on these outcomes.

Study Details

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

   • Audiological outcomes: 168 patients (115 female, 53 male), mean age 46.4 ± 12.9 years (range 12-70). Implanted ear: 86 right, 82 left.
   • Adverse events: 188 patients (127 female, 61 male), mean age 47 ± 13 years (range 12-82). Implanted ear: 98 right, 90 left.
   • Data Provenance: Europe, multicenter, retrospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   The document does not explicitly state the number or qualifications of experts who established the "ground truth" (audiological outcomes, adverse events) for the clinical study. However, it indicates that the study was a Post-Market Clinical Follow-Up (PMCF) investigation, and audiological outcomes would typically be measured and interpreted by audiologists or ENT specialists.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   The document does not specify an adjudication method for the clinical 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, this was not an MRMC comparative effectiveness study. The device is a passive middle ear implant for surgical implantation, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This question is not applicable. The device is a physical implant, not an algorithm.

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

   • Audiological Outcomes Data: Postoperative pure tone average (PTA4) air-bone gap (ABG) measurements.
   • Adverse Events Data: Recorded occurrences of adverse events, device dislocations/extrusions, and revision surgeries.

7. The sample size for the training set:
   This question is not applicable as the device is a physical implant, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established:
   This question is not applicable.

Ask a specific question about this device