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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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An 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. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

The Grace Dynamic Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:
(i) Unalloyed titanium (ASTM F67)
(ii) Titanium alloy (ASTM F136)
(iii) Medical Grade Silicone
(iv) ASTM F1185 Hydroxylapatite

The provided document is a 510(k) summary for the Grace Dynamic Ossicular Replacement Prostheses. This type of regulatory document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, and technological characteristics. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or performance study report for a diagnostic AI device would.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, or training set details) because this document does not contain that type of data.

The 510(k) summary states: "Differences between the Grace Dynamic Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness." This statement, along with the comparison of materials and intended use to predicate devices, forms the basis of the "proof" for substantial equivalence in this context, rather than a detailed performance study with quantifiable acceptance criteria.

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Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.

Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include. fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window.

Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical qauge (code 02.14) The implant must be carried out by a qualified surgeon.

Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.

Otosurgical prosthesis of the middle hear, are manufactured from a wide variety of materials: titanium, poliethylene (PE), stainless steel, hydroxylapatite (HA). platinum (Pt). politetrafluoroethylene (PTFE), gold, polimetilxilossano (silicon) and Nitinol, or combination of these materials.

Numerous designs are available for replacement of any or all of the bones of the ossicular chain.

The provided document is a 510(k) premarket notification for an "Audio Prosthesis" (Total/Partial Ossicular Replacement Prosthesis). It describes the device, its intended use, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states that the device is "substantially equivalent" to legally marketed predicate devices based on having the same indications for use, technological characteristics (materials), and general design. The FDA's letter (K083780) confirms this substantial equivalence determination.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance), ground truth details, or training set information from this document.

The document primarily focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with specific acceptance criteria.

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The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.

The FISCH Titanium Middle Ear Prostheses are made of anodized titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.

The provided document is a 510(k) Summary for medical devices (FISCH Titanium Middle Ear Prostheses). This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It typically does not contain information about the device's performance in terms of specific measurable criteria, nor does it typically include clinical study data in the way one might expect for a novel device requiring extensive clinical trials. Instead, the focus is on comparing the new device's intended use, technological characteristics, and safety/effectiveness profile to an already approved device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Based on the nature of this submission, the "study" that proves the device meets acceptance criteria is primarily a comparison of the new device to a predicate device and a demonstration of substantial equivalence, rather than a standalone performance study with measurable outcomes against defined acceptance criteria.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance criteria" here is implicitly that the Karl Storz FISCH Titanium Middle Ear Prostheses are substantially equivalent to the predicate Stryker/Leibinger FISCH Titanium Middle Ear Prostheses in terms of intended use, dimensions, material, single use, sterility, and design.
• Reported Device Performance: No specific performance metrics (e.g., auditory gain, complication rates) are reported. The "performance" is considered equivalent to the predicate device due to the similarities highlighted in the tables.

Table of Substantial Equivalence (summarized from the document):

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

• Not applicable as this is not a clinical performance study with a test set. It's a regulatory submission demonstrating equivalence.

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

• Not applicable. Ground truth as typically established by experts for performance evaluation is not part of this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable.

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 device is a passive implantable medical device, not an AI-powered diagnostic tool.

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

• Not applicable. This device is a passive implantable medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the safety and effectiveness profile of the predicate device, which has already been legally marketed and deemed safe and effective by the FDA. The new device is compared against this established benchmark.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

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

• Not applicable.

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Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.

The provided document is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics. It focuses on demonstrating substantial equivalence to predicate devices based on design and safety characteristics, rather than reporting on specific performance outcomes from a clinical study with predefined acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness simply does not exist within this 510(k) submission.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided in the 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence based on design similarities and a qualitative assessment of safety and effectiveness, rather than quantitative performance against pre-defined acceptance criteria from a specific study.

2. Sample Size Used for the Test Set and Data Provenance

Not provided in the 510(k) summary.

No specific "test set" and its sample size are mentioned, as this is a premarket notification based on design changes and comparison to predicate devices, not a clinical trial reporting on performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/Not provided in the 510(k) summary.

No "ground truth" establishment in a clinical context is described, as there is no reported performance study with a test set.

4. Adjudication Method for the Test Set

Not applicable/Not provided in the 510(k) summary.

No adjudication method is described, as there is no reported performance study with a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done or reported in this 510(k) summary.

The submission focuses on design modifications and claims that the new device, by improving handling and reducing risks, is "expected to result in equal if not better audiological postoperative hearing gain." This is a qualitative statement of expectation, not a result from a comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not provided in the 510(k) summary.

This device is a physical medical implant, not an algorithm or AI system. Therefore, the concept of "standalone performance" in that context is not relevant.

7. The Type of Ground Truth Used

Not applicable/Not provided in the 510(k) summary.

No ground truth is described in the context of a performance study. The "safety and effectiveness" claims are based on design comparisons to predicate devices and theoretical advantages of the new design features. The statement "Clinical test results confirm the safety and effectiveness of this design" is made, but no details of these "clinical test results" are provided, nor is the nature of the "ground truth" used.

8. The Sample Size for the Training Set

Not applicable/Not provided in the 510(k) summary.

No training set is mentioned, as this is not an AI/algorithm-based device and no such study is described.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided in the 510(k) summary.

No training set is mentioned, and therefore, no ground truth establishment for it.

Summary of what is present in the document relevant to safety and effectiveness:

• Rationale for Design Changes: The document clearly outlines the reasons for modifying the device, primarily focusing on facilitating intraoperative handling, reducing risks of patient trauma, and improving post-operative sound transmission.
• Safety Features: Mention of reduced tissue necrosis by improving vascular circulation, standardization and shortening of surgical procedures, elimination of instruments and crimping, and reduction of potential risks.
• Theoretical Performance Improvement: Expectation of "equal if not better audiological postoperative hearing gain" due to gentle clip-on attachment and alignment with sound transmission axis.
• MRI Compatibility: Testing in a 3.0 Tesla NMR tomograph revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
• Comparison to Predicate Devices: A detailed table compares the new device (CliP® Piston MVP) to its predicate devices (Titanium K-Piston and CliP® àWengen) in terms of design, intended use, materials, and specific features, highlighting the modifications and their perceived benefits.
• Conclusion on Safety and Effectiveness: The document concludes that the results of design validation raise no new issues of safety and effectiveness, and that "clinical test results confirm the safety and effectiveness of this design," though these results are not detailed.

Essentially, this 510(k) submission argues for substantial equivalence primarily through comparison of design features and theoretical benefits based on those design changes, rather than providing detailed data from a quantitative performance study with explicit acceptance criteria.

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Reconstruction of the sound conduction chain between the base of stapes and the tympanic membrane level by replacing the missing middle ear bones with a total implant in the sense of a tympanoplasty of type IIIC given an existing intact base of stapes with normal mobility and without luxation.

Titanium Ossicular Replacement System

The provided text is a 510(k) clearance letter from the FDA for the "Titanium Ossicular Replacement System." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or any studies conducted.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance evaluation against specific criteria or study results.

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Ask a specific question about this device