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Bell Implants (Gold and Titanium): The KURZ Bell implants are intended for partial replacement of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prostheses are implanted into the middle ear during a tympanoplasty procedure and are retained in the middle ear by the design configuration of the devices and the favorable biocompatible characteristics of gold and titanium.
Angular Prosthesis (Plester) (Gold with Titanium Bands): The KURZ Angular Prosthesis is intended to bridge defects at the long incudal process and otherwise intact chain.
Bell Prosthesis (Partial): Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate. The Bell Prosthesis is intended for partial replacement of the auditory ossicles.

The implant consists of a golden wire rectangle or an extremely thin mesh plate with a structured outer surface and a stem which is available in 1/4mm incremental lengths. It ends in a 'bell' with miniscule slits.
The implant consists of a titanium mesh plate that is textured on the surface that faces the tvmpanum. A bell with four slits and a textured inner side is located at the upper end of the shaft.
The Angular prosthesis (Plester) consists of a slit bell, an angular stem (both Au), and two (2) titanium clamps at its end. The open ends of the titanium clamps are slightly staggered, so that they do not touch each other.
The devices are implants for single patient use. They come in an individual sterile package in a sealed carton.

Unfortunately, the provided documents (510(k) summary and FDA clearance letters) for the Heinz Kurz GmbH Medizintechnik ossicular prostheses do not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the way you've requested.

Here's why and what information is provided:

What a 510(k) Summary and Clearance Letter Contain:

A 510(k) premarket notification is a regulatory submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically focuses on:

• Intended Use: What the device is designed to do.
• Technological Characteristics: How it's made and what it's made of (e.g., gold, titanium).
• Comparison to Predicate Devices: Showing it's similar in design, materials, and function to devices already on the market.
• Biocompatibility (often mentioned implicitly or through material choice): Ensuring materials are safe for implantation.
• Sterility: How it's sterilized and packaged.
• Labeling: Instructions for use.

What is Typically Not in a 510(k) Summary (especially for devices cleared decades ago):

• Formal clinical studies with detailed acceptance criteria, performance metrics, and statistical analysis: For most Class II devices (like these ossicular prostheses), especially those cleared before the mid-2000s, clinical trials demonstrating specific performance metrics against pre-defined acceptance criteria were often not required if substantial equivalence could be shown through design, materials, and intended use. The FDA relied heavily on a comparison to existing, already-cleared devices.
• Specific sample sizes, data provenance, expert qualifications for ground truth, or adjudication methods for clinical performance evaluation: These are elements of a formal clinical trial or performance study, which, as noted, were not explicitly presented in this type of submission for this device.
• MRMC comparative effectiveness studies: These are highly sophisticated clinical study designs usually associated with diagnostic imaging or AI devices, not typically a mechanical implant like an ossicular prosthesis.
• Standalone algorithm performance: This is irrelevant as these are physical implants, not AI algorithms.
• Ground truth types for performance studies: Again, not typically applicable to the evidence presented in a 510(k) for this type of device.
• Training set sample sizes or ground truth establishment for training: Irrelevant for a non-AI, physical implant.

Based on the provided text, here's what can be extracted and why the rest cannot be filled:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. No "test set" in the context of a performance study is described. The submission focuses on substantial equivalence to existing devices.

3. 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)

• Not applicable/Not provided. This information pertains to a formal performance study, which is not described. The ground truth for this device's regulatory clearance is its similarity to already-cleared devices that are considered safe and effective in clinical use by the medical community.

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

• Not applicable/Not provided.

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

• No. This type of study is completely irrelevant for a mechanical ossicular implant. It's designed for diagnostic tools, often involving interpretation by human "readers" (e.g., radiologists) with or without AI assistance.

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

• No. This is a physical implant, not an algorithm.

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

• Implicit "Ground Truth": The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (Smith & Nephew Richards and Xomed ossicular devices). The submission argues that the Kurz devices are so similar in design, materials, and intended use that they can be expected to perform equivalently. There isn't a separate, explicit "ground truth" established for this specific device's performance in the document.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI device with a training set.

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

• Not applicable/Not provided.

In summary, the provided documents represent a 510(k) submission, which relies on demonstrating "substantial equivalence" to existing legally marketed devices, rather than presenting a de novo clinical study with specific acceptance criteria and performance data for the device itself. Therefore, much of the information you've requested is not typically part of such a submission.

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