Search Results

Vivosonic NeuroScreen™ is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen M is indicated for newborns and infants from 34 weeks gestational age to 6 months.

Not Found

I am sorry, but the provided text is a 510(k) summary from the FDA for the Vivosonic NeuroScreen™ Infant Hearing Screener. It outlines the regulatory approval process and includes the indications for use.

However, it does not contain any information about the acceptance criteria, the specific study conducted to prove device performance, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot fulfill your request for this information based on the provided text.

Ask a specific question about this device

VivoSonic™ will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between patient and medical imaging electronics and to lubricate the insertion and passage of imaging devices, such as ultrasound transducers and endoscopes.

VivoSonic™ is intended for use in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and opthalmic ultrasound imaging.

VivoSonic™ is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures which currently use and ultrasound coupling gel or fluid alone or in combination with a latex, non-latex, polyurethane or polyethylene transducer cover where sterility and/or in vivo biocompatibility are required.

VivoSonic™ is an in vivo biocompatible sterile ultrasound couplant and lubricant that couples or conducts ultrasound between the body and the ultrasound transducer and electronics.

The VivoSonic™ formulation is in vivo biocompatible with tissue and body fluids and is recognized as safe for oral administration (1)

This is a 510(k) Premarket Notification for the VivoSonic™ Diagnostic Ultrasound Imaging Coupling Media. This document does not contain information about the performance of an AI/ML device.

The provided text describes a medical device (ultrasound coupling media) and its intended use, and states that it is substantially equivalent to other legally marketed predicate devices. It covers regulatory information, device classification, and indications for use.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, study details, ground truth establishment, or human-in-the-loop performance, as these topics are not present in the provided submission for this type of device.

Ask a specific question about this device

Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices.

Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging.

Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.

VivoSonic - In Vivo Biocompatible Sterile Ultrasound Imaging Couplant

This document is a 510(k) premarket notification for a medical device called VivoSonic (Diagnostic Ultrasound Imaging Coupling Media). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device that does not require premarket approval (PMA). This is a regulatory clearance process, not a performance study.

Therefore, I cannot provide the requested information based on the provided text, as it does not include:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document primarily focuses on the regulatory aspects of the device, its intended use, and its substantial equivalence to other devices already on the market.

Ask a specific question about this device