Search Results

The Hitachi Aloka Medical, Ltd UST-5310 or UST-5311 or UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intraoperative and Intra-operative (neurosurgery) procedures.

This device is not indicated for Ophthalmic applications.

Linear Array transducer

The provided text is a 510(k) summary for a medical device (ultrasound transducers). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way you've outlined.

The document states:

• "No new hazards were identified with the addition of the UST-5311 transducers to the PROSOUND ALPHA7 & ARIETTA70."
• "The subject systems and the transducers have been evaluated for acoustic output, biocompatibility, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards."
• "Clinical testing: None required"

This means the submission relies on demonstrating that the new application (using existing transducers with new ultrasound systems) does not introduce new risks and that the components (transducers and systems) individually meet safety and performance standards. It does not describe a performance study with acceptance criteria in the context of diagnostic accuracy, sensitivity, specificity, etc., which would typically be included for devices that provide diagnostic insights.

Therefore, I cannot provide the answer in the requested format because the necessary information is not present in the provided text. The document is essentially declaring that the existing transducers, when used with modified systems, are still safe and effective as previously determined, without the need for a new study to assess their diagnostic performance against specific acceptance criteria.

Ask a specific question about this device