(47 days)
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):
| Feature | Predicate Device (Stryker/Leibinger) | Karl Storz Device | Comparison |
|---|---|---|---|
| Intended Use | Ossicle replacement to restore middle ear function. | Same | Equivalent |
| Dimensions | Specific lengths and diameters for Stapes Piston, Incus, Neomalleus, Total Prosthesis | (Slightly different model numbers, but same dimensions) | Equivalent |
| Material | Titanium | Anodized Titanium (for Incus, Neomalleus, Total) / Titanium (for Stapes) | Equivalent (Anodized Titanium is a form of Titanium) |
| Single Use | Yes | Same | Equivalent |
| Sterile | Yes | Same | Equivalent |
| Design | One-piece, flat loop (Stapes); allows shaping, 4 holes (Incus); smooth/grooved (Neomalleus); plate with shaft/shoe (Total) | Same | Equivalent |
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.
§ 874.3495 Total ossicular replacement prosthesis.
(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.