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Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, during the first 14 days following surgery and helps prevent obstruction by adhesions.

Sphenoid Sinus Stent

This document is a 510(k) clearance letter from the FDA for the Micromedics Sphenoid Sinus Stent. It primarily establishes substantial equivalence to a predicate device and outlines regulatory compliance requirements. It does not contain the acceptance criteria, study details, or performance data asked for in the prompt.

Therefore, an answer fulfilling all requirements of the prompt cannot be generated from the provided text. The document acts as a regulatory approval, not a scientific study report.

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For surgical reconstruction of the sound conduction chain between the stapes and the ear drum, where the stapes is intact and mobile, by replacement of the missing ossicles with a partial implant.

S&T Partial Ossicular Replacement Prosthesis

This document is a 510(k) premarket notification for a medical device (S&T Partial Ossicular Replacement Prosthesis), indicating FDA clearance for marketing. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in clinical study reports, scientific publications, or detailed sections of a premarket application. This specific FDA letter and its linked "Statement of Indications for Use" only confirm that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, I cannot fulfill your request based on the provided text. The document does not contain the necessary details to describe the acceptance criteria and the study that proves the device meets them.

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For surgical reconstruction of the ossicular chain between the stapes footplate and ear drum where the stapes footplate is present and mobile.

S&T Total Ossicular Replacement Prosthesis

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "S&T Total Ossicular Replacement Prosthesis" and primarily states that the device is substantially equivalent to legally marketed predicate devices.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or expert qualifications for a test set.
• Information on adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• The type of ground truth used.
• Training set sample size or how its ground truth was established.

This document is a regulatory approval notice, not a detailed technical report or study summary. Therefore, the requested information is not available in the provided text.

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