Search Results

The Exact Vu micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use (clinical applications) are:
• Small Organ
• Transrectal
• Abdominal

The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.

The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises transducers responsible for ultrasound signal generation and recording, needle guides and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

The provided text is a 510(k) summary for the ExactVu™ High Resolution Micro-Ultrasound System (K190995). It explicitly states that no clinical studies were required or performed to support the determination of substantial equivalence for this device and its transducers/needle guides.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, and MRMC studies for a clinical trial is not available within this document. The submission relies on non-clinical tests and a comparison to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the information that is available based on your request, highlighting the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available from a clinical study within the provided document, as no clinical studies were performed. The document focuses on regulatory compliance and technological characteristics in comparison to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as no clinical test set was used for a clinical study to demonstrate performance. The submission relies on non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no clinical test set was used requiring expert ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical test set requiring adjudication was used.

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

An MRMC comparative effectiveness study was not performed. The document states that the ExactVu system did not require clinical studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

A standalone performance study was not performed in a clinical context. The device is an imaging system intended for use by qualified medical professionals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as no clinical studies requiring a ground truth were performed. Safety and effectiveness were established through non-clinical compliance with standards and comparison to a predicate device.

8. The sample size for the training set

This information is not applicable as no clinical studies involving a training set for an AI/algorithm were performed or reported in this device submission.

9. How the ground truth for the training set was established

This information is not applicable as no clinical studies involving a training set were performed or reported in this device submission.

Summary from the document (Section 7, "Summary of Clinical Tests"):

"The ExactVu System, transducers and needle guides, subject of this submission, did not require clinical studies to support the determination of substantial equivalence. An analysis of clinical literature, adverse event and recall data is provided in the clinical evaluation justifies the safety and efficacy of the functionality of the ExactVu device without pre-market clinical investigation." (Page 14)

The device's substantial equivalence was supported by:

• Non-clinical tests for electrical, thermal, mechanical, and EMC safety.
• Evaluation of cleaning/disinfection and biocompatibility.
• Compliance with recognized voluntary standards (e.g., AAMI/ANSI/ISO 10993-1, IEC 60601-1, IEC 60601-2-37, NEMA UD 2-2004).
• Demonstration of a comparable quality system (ISO 13485:2016 and MDSAP).
• Comparison of technological characteristics to a predicate device (ExactVu 2.0, K180636) and a reference device (Ultrasound Scanner Flex Focus 1202, K132335).

Ask a specific question about this device