(266 days)
INTENDED USE: The passive middle ear implant - tympanoplasty partial 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 partial 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 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 partial ossicular replacement prosthesis is indicated, if at least the stapes head and its stapes footplate are present and functional.
Tympanoplasty Sizers for partial prosthesis: INTENDED USE: The tympanoplasty Sizers are intended to be used during a partial 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 partial prosthesis are intended to intraoperatively determine the distance between the head 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 partial prostheses apply.
The MED-EL "Passive Middle Ear Implants" (PMEI) Tympanoplasty Partial Prostheses are partial 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 text describes the regulatory clearance for the MED-EL PMEI Tympanoplasty Partial Prostheses and includes details about non-clinical and clinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does not outline specific, quantitative acceptance criteria with corresponding "reported device performance" in a table format as typically requested for AI/ML device submissions. Instead, it discusses the outcomes of the clinical study in relation to the "state of the art" and provides general performance metrics.
Here's an attempt to extract and frame the information according to your request, with the understanding that specific acceptance criteria in the exact format you provided are not explicitly stated in this document for the device itself, but rather for the performance relative to existing treatments.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative "acceptance criteria" for the device's performance in a tabular format are not clearly defined in the provided document, I will infer them from the clinical outcomes that were deemed acceptable by the manufacturer for demonstrating substantial equivalence. The document primarily focuses on achieving outcomes comparable to the "state of the art."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Effectiveness: | |
| % of patients with postoperative PTA4 Air-Bone Gap (ABG) ≤ 20 dB (comparable to state of the art, which is 62.5-71.3%) | 72% of patients with postoperative PTA4 ABG ≤ 20 dB |
| Mean BC-PTA4 (Bone Conduction Pure Tone Average) before surgery | 19.8 ± 12.2 dB HL |
| Mean BC-PTA4 (Bone Conduction Pure Tone Average) after surgery | 17.9 ± 12.2 dB HL |
| Rate of BC-PTA4 deterioration > 10 dB HL | 3.2% (6/186 patients) |
| Safety: | |
| Rate of (recommended) revision surgeries | 5 (out of 202 patients) |
| Rate of (potential) device dislocations/extrusions | 3 (out of 202 patients) |
| Total Adverse Events (AEs) | 34 AEs in 21 patients |
2. Sample size used for the test set and the data provenance
- Sample Size for Audiological Outcomes: 186 patients (89 female, 97 male)
- Sample Size for Adverse Events: 202 patients (98 female, 104 male)
- Data Provenance: The study was a "large multicenter, retrospective, single-subjects repeated measures (each subject served as his or her own control) Post-Market Clinical Follow-Up (PMCF) investigation with the PMEI Tympanoplasty Partial Prostheses in Europe."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish "ground truth" in the context of image interpretation or similar diagnostic tasks. The ground truth for the clinical outcomes (audiological data, adverse events) was established by direct clinical measurements and follow-up, not by expert consensus on data interpretation. The "Intended User" is stated as "qualified ENT surgeons only, with adequate skills to perform otological surgeries," who would be responsible for the clinical procedures and likely the reporting of outcomes.
4. Adjudication method for the test set
Not applicable. The study involved direct clinical outcomes and adverse event reporting, not a process requiring adjudication of interpretations (e.g., of medical images) by multiple experts.
5. 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
Not applicable. This document describes a medical device (a passive middle ear implant) with an associated clinical study, not an AI/ML-powered diagnostic or assistive tool involving human readers. Therefore, an MRMC study and effects on human reader performance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was outcomes data, specifically:
- Postoperative audiological measurements (PTA4 ABG, BC-PTA4).
- Reported adverse events, including device dislocations/extrusions and revision surgeries.
These were collected directly from patient follow-ups.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.