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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."

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.

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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

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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.

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