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The SONOLINE Versa 555 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative (abdominal and neurosurgical), Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Transesophageal Echocardiography (TEE) applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Diagnostic ultrasound imaging and Doppler analysis of the human body as follows: Cephalic Adult, Cephalic Neonatal, Cardiac Adult, Cardiac Pediatric.

The SONOLINE Versa 555 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

The provided text is a 510(k) summary for the SONOLINE Versa 555 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study on the device's clinical performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including details like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, cannot be extracted from the provided text because such a study is not described.

The document details the device's technical specifications, intended uses, and compliance with safety standards and regulatory requirements for market clearance. It does not contain information about a clinical performance study with specific metrics.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not present any clinical performance data or specific acceptance criteria for a clinical study. It refers to compliance with safety standards (UL, CSA, AIUM/NEMA, EEC, EN60601) and substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance: No clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: The device described is a diagnostic ultrasound system, not an AI-based system, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a human-operated ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): No clinical ground truth is described in the context of device performance.
8. The sample size for the training set: The document does not describe any machine learning or AI components with a training set.
9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, the provided 510(k) summary focuses on regulatory compliance and technical similarity to previously cleared devices, not on a clinical performance study with specific acceptance criteria and outcome metrics.

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