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Ceramisys synthetic orbital implants of either hydroxyapatite or alumina oxide (alumina) are indicated for orbital implantation at the time of enucleation or evisceration of the natural eyeball. They may also be indicated for secondary implantation where extrusion, migration or other malfunction of the primary orbital implant has occurred.

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This document is a 510(k) premarket notification letter from the FDA regarding "Ceramisys Synthetic Orbital Implants." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.

The letter is an administrative notice approving the device for marketing and mentions the indications for use, but it does not include data from performance studies. Therefore, I cannot provide the requested information based on the provided text.

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Mesh wrapped Bioceramic orbital implants are designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.

Mesh Wrapped Bioceramic Orbital Implant

I apologize, but this document is not a study that proves the device meets the acceptance criteria. This is a 510(k) clearance letter from the FDA, indicating that the device, "FCI Mesh Wrapped Bioceramic Orbital Implant", is substantially equivalent to legally marketed predicate devices.

A 510(k) clearance does not typically include a detailed study proving performance against specific acceptance criteria in the way a clinical trial report would. Instead, it demonstrates substantial equivalence, often through comparisons of design, materials, and intended use to a previously cleared device, along with preclinical testing (e.g., biocompatibility, mechanical testing) rather than a clinical study focused on performance metrics like sensitivity or specificity.

Therefore, I cannot provide the information requested in your prompt based on the provided document. The document primarily focuses on regulatory clearance rather than a detailed performance study with acceptance criteria.

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As a primary implant for patients who present with eye disease or severe damage such that the eye must be enucleated or eviscerated.

An existing orbital implant that is malfunctioning or not satisfying the patient in terms of performance, may call for a secondary implant procedure to install a bio-ceramic orbital implant.

Bio-ceramic Orbital Implant

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a Bioceramic Orbital Implant, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance data or study results.

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