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The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use are:

• Small Organ
• Transrectal ●
• Abdominal ●

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 of 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 document describes the FDA 510(k) summary for the ExactVu™ High Resolution Micro-Ultrasound System (K192303). It outlines the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

However, the document explicitly states:
"This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing."

This means that the provided text does not contain any information about a clinical study involving the device's performance against acceptance criteria in a real-world setting with human subjects, AI assistance, or expert readers. The document focuses solely on non-clinical performance testing (e.g., functional verification, human factors, biocompatibility, electrical safety, acoustic testing) to establish substantial equivalence to a previously cleared predicate device.

Therefore, I cannot provide answers to the requested points that pertain to clinical study data, such as:

• A table of acceptance criteria and reported device performance from a clinical study.
• Sample size used for a test set (clinical).
• Number of experts and qualifications for ground truth establishment.
• Adjudication method for a clinical test set.
• MRMC comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used (clinical).
• Sample size for the training set (clinical).
• How ground truth for the training set was established (clinical).

Based on the provided text, the device's acceptance was based on non-clinical performance testing demonstrating substantial equivalence to a predicate device, not on a clinical study with a test set, expert readers, or AI performance metrics.

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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).

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The ExactVu High Resolution 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 are:
Small Organ (prostate) Transrectal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

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 does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria with performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to various safety and performance standards.

However, based on the information provided, here's a breakdown of what can be inferred and constructed:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of the submission (510(k) for an ultrasound system) and the provided text, the "acceptance criteria" appear to be compliance with relevant safety and performance standards, and comparison to existing legally marketed devices. As no specific performance metrics are given in the provided text, the table is structured to reflect this.

2. Sample size used for the test set and the data provenance:

The document explicitly states: "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."

Therefore, no specific test set or clinical study data (including sample size or data provenance) is provided for the subject device (ExactVu 2.0) in this submission. The determination of substantial equivalence relies on non-clinical tests and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

As per point 2, no specific clinical test set was used to establish ground truth because clinical studies were not required for this submission.

4. Adjudication method for the test set:

As per point 2, no specific clinical test set was used, so no 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:

No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in improving human reader performance. The submission is for an ultrasound system, not an AI-powered diagnostic tool.

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

Not applicable. This submission is for an ultrasound imaging system, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI performance.

7. The type of ground truth used:

Given the absence of clinical studies for this submission, the "ground truth" for demonstrating safety and effectiveness relied on:

• Conformance to recognized industry standards: (e.g., IEC 60601-1, ISO 10993-1, NEMA UD 2 & 3). Third-party testing and certification against these standards serve as the "ground truth" for the device's adherence to established safety and performance benchmarks.
• Substantial equivalence to a legally marketed predicate device: The predicate device (ExactVu 1.0, K162972) implicitly provides the "ground truth" of a device that has already been deemed safe and effective for its intended use. The submission argues that the new device is sufficiently similar to share this established safety and effectiveness profile.

8. The sample size for the training set:

Not applicable. There is no mention of machine learning or AI components requiring a training set in this submission.

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

Not applicable. As no training set is mentioned (see point 8).

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The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body; the intended uses are:

Small Organ (prostate) Transrectal

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

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

The provided FDA 510(k) summary for the ExactVu High Resolution Micro-Ultrasound System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria related to its diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards rather than clinical performance metrics.

Specifically, the "Summary of Clinical Tests" section on page 10 explicitly states: "The ExactVu System, transducers and needle guide, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device