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UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace sterilized transcutaneous scanning gels that are not in vivo biocompatible or in vivo bioeliminated in surgical procedures, biopsies and similar sterile applications.

UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during transcutaneous and intracavitary medical diagnostic ultrasound imaging procedures. It will be used with transcutaneous and intracavity ultrasound imaging.

UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or fluid alone or in combination with a latex sheath where sterility and bioelimination are required.

UltraBio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "UltraBio - In Vivo Biocompatible Bioeliminated Sterile Ultrasound Imaging Couplant". This document is an approval letter for a medical device and does not contain information about acceptance criteria, device performance studies, or clinical trial details as requested in your prompt.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This indicates that the device's approval is based on its substantial equivalence to existing predicate devices, rather than a new study proving specific performance against acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace UltraBlo, as an in Wo bloompatible and brookers on in vivo bioshested on vivo biosxcretable, but sterilized transculaneous sounting gold transmilar sterile applications.

UltraBio will be used to couple sound waves between the patient and medical imaging electronic UltraBlo will be used to couple sound waves between in the material consisted on the consective transducers during intraoperative and intraction in and aspiration, intraoperative ultrasound imaging, and intracavity ultrasound imaging.

UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound Ultration is unlift use packaged, sichiles and interess for fluid alone or in combination with a latex, and procedures that canently use an undaound beaping get in the biocompatibility and bioelimination are required.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a device named "Ultrabio - InVivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant," primarily discussing its regulatory classification and indications for use. It does not contain the kind of technical performance study details requested in your prompt.

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