(19 days)
The Lelbinger titanium ossicular chain reconstruction prostheses and accessories are used 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.
Titanium ossicular chain reconstruction prostheses are available for the following indications:
Chronic otitis media
Immobility of the stapes (otosclerosis in particular)
Injury of the ossicle (trauma)
Abnormal and defective formation of the middle ear
Secondary procedure to improve hearing
Revision operation on a malpositioned prosthesis
The system consists of various implants, instrumentation, and storage containers.
| Product Designation | Product Intended Use |
|---|---|
| Stapes prosthesis | Flat band and piston prosthesis for attachment to the malleus or incus, inserted through the footplate of the stapes. |
| Total prosthesis (TORP) | Plate prosthesis with shaft and shoe as ossicle replacement between the tympanic membrane and the footplate of the stapes. |
| Neomalleus total prosthesis | Malleus prosthesis as ossicle replacement In combination with stapes prosthesis. - |
| Incus prosthesis | Incus replacement to connect malleus and head of stapes. |
| Partial prosthesis (PORP) | Malleus and incus replacement to connect tympanic membrane and head of stapes. |
This is a 510(k) summary for a medical device cleared in 1999, which predates the widespread use of AI/ML in medical devices and the associated regulatory expectations for studies proving AI performance. Therefore, the document does not contain information related to AI acceptance criteria or studies.
The document describes the Zürich Titanium Ossicular Replacement System, a device for ossicle replacement to restore middle ear function. The basis for its clearance is substantial equivalence to predicate devices already on the market, not a detailed performance study with acceptance criteria as would be required for a novel AI device today.
Therefore, I cannot provide the requested information regarding AI acceptance criteria and studies from the given input.
However, I can extract information relevant to the device's regulatory submission based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The device's acceptance was based on its substantial equivalence to predicate devices, meaning it met the requirements for intended use, materials, design, and operational principles established by already marketed devices. There are no specific quantifiable performance metrics described as acceptance criteria in this document for the device itself, beyond being "substantially equivalent."
- Reported Device Performance: The document states the device "is intended to be used for ossicle replacement to restore middle ear function when the sound transmission chain is broken." There are no reported performance metrics (e.g., success rates, hearing improvement statistics) within this 510(k) summary.
2. Sample size used for the test set and the data provenance: Not applicable. Device was cleared based on substantial equivalence, not a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device was cleared based on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device was cleared based on substantial equivalence.
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 an implantable medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implantable medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI study. The "ground truth" for this device's clearance was that it was substantially equivalent in design and intended use to existing, legally marketed devices.
8. The sample size for the training set: Not applicable. This device is an implantable medical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This device is an implantable medical device, not an AI algorithm.
§ 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.