Search Results

The DIOP8 surgical Doppler is indicated for use by qualified healthcare practitioners in a sterile condition in the operating theatre for the assessment of vascular blood flow by direct application to the vessel wall.

The DIOP8 is a sterile, single use, high sensitivity probe that assists in the performance of safe surgery. It is a lightweight, 8MHz ultrasound, handheld pencil probe' that has a small diameter tip that enables the detection of blood flow in vessels. The DIOP8 ultrasound probe operates in pulsed-wave mode. It has one circular piezo-electric crystal that is mounted behind the front faceplate and the crystal is used for both transmit and receive functions. The DIOP8 is manufactured at a frequency of 8MHz. The output ultrasonic parameters are fixed during the manufacturing process and cannot be adjusted by the user. A connector system at the end of the cable allows the DIOP8 to be removed from the hand held Doppler. An interconnection adapter houses the bi-directional electronics, which are specific for the device application, and is required as an interface between the main unit and DIOP8. The connector is similar to a conventional connector, but has no external conductive contacts, and is totally sealed, thus preventing the ingress of fluid and contaminants. Within the connector is a small coil that transfers electrical energy to and from a similar, but larger coil in the corresponding socket at the end of the PA8/PA8XS adapter. Transmitted and received electrical signals are passed through this connector, but there is no direct electrical connection between the probe and the PA8/PA8XS adapter. The connector provides electrical isolation between the probe and the PA8/PA8XS adapter, which optimises system electrical safety by limiting patient leakage currents to very low levels. During use, the adapter is securely held in the probe holder that is an integral part of the Doppler main unit. When connected this way, the hand held Doppler unit operates as if a normal VP8 probe is connected.

The requested information is not available in the provided text. The document is a 510(k) summary for a medical device (Disposable Intraoperative Probe - DIOP8) and details the device's characteristics, comparison to a predicate device, and various performance tests conducted. However, it does not include specific acceptance criteria with reported device performance values in a table, nor does it describe a study proving the device meets those criteria with a breakdown of sample sizes, ground truth establishment, expert involvement, or MRMC study results.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general performance testing (biocompatibility, mechanical, functional, electrical safety, EMC, environmental, and software).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size details for test and training sets, data provenance, number of experts, adjudication methods, MRMC study results, or standalone performance results based on the provided text.

Ask a specific question about this device