Search Results

The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.

The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans.

The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.

The provided text is a 510(k) summary for the Vitrolife Ultrasound Transducer Cover. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate safety and effectiveness.

However, the document does not contain information about:

• Acceptance criteria in the context of a statistical study with specific thresholds for performance metrics.
• A study proving the device meets acceptance criteria related to diagnostic accuracy, especially not for an AI/ML-enabled device as implied by the detailed questions about ground truth, expert consensus, MRMC studies, and standalone performance.
• Sample sizes for test sets or training sets in the context of an AI/ML study.
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types pertaining to an AI/ML diagnostic system.
• Training set size or how its ground truth was established.

The document is for a physical medical device (an ultrasound transducer cover) and focuses on biocompatiability, functional performance (e.g., leakage, ultrasound visibility), sterilization, and shelf-life testing, demonstrating substantial equivalence to a predicate device. It explicitly states "Clinical Testing: Not applicable."

Therefore, I cannot populate the requested table and provide answers for the specific points related to AI/ML device validation because the provided text does not contain this information.

The existing text is a regulatory submission for a simple medical device, not an AI/Machine Learning diagnostic device.

Ask a specific question about this device