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The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

Specific clinical applications and exam types include:

Abdominal
Dermatological
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Neonatal Cephalic
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)

The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire ad display high-resolution, real-time ultrasound data in 2D, Color Doppler, Power Doppler, PW Doppler and M-Mode. The Vevo MD Imaging System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

This document, K190476, details the 510(k) premarket notification for the FUJIFILM SonoSite Vevo MD Imaging System.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance metrics from device testing. The document states that the device was evaluated for safety and effectiveness against its predicate. The "acceptance criteria" for a 510(k) typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The study presented does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) or report numerical device performance against such metrics. Instead, it relies on demonstrating equivalence through:

• Intended Use Alignment: Both the new device and the primary predicate (FUJIFILM SonoSite Vevo MD Imaging System K160674) share the same intended use.
• Technological Characteristics Comparison: The document provides a table comparing features, modes of operation, acoustic output, DICOM capabilities, and channels with the predicate devices. The new device and primary predicate are highly similar, particularly for "Track 3" devices.
• Compliance with Voluntary Standards: The device is designed to comply with several recognized standards related to biological evaluation, electrical safety, electromagnetic disturbances, ultrasonic medical diagnostic equipment, field characterization, software life cycle, and risk management. This compliance forms a key part of demonstrating safety.

Summary of "Acceptance Criteria" (Implicit) and Reported Performance:

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The Vevo MD Imaging System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means there was no clinical "test set" in the traditional sense of patient data used to evaluate performance metrics like sensitivity or specificity. The evaluation was primarily non-clinical, comparing technical specifications and adherence to standards against a predicate device. Therefore, no information on sample size or data provenance for a clinical test set is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As no clinical study was conducted for performance evaluation in this 510(k) submission, there was no "ground truth" to be established by experts for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set for performance evaluation 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

Not applicable. This device is an imaging system, not an AI-based diagnostic aid that would involve human readers improving with AI assistance. Clinical studies were not performed for this submission.

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

Not applicable. This device is an imaging system, not a standalone algorithm. Clinical studies were not performed for this submission.

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

Not applicable, as no clinical study for performance evaluation was conducted where ground truth would be established. The "ground truth" for this submission revolves around the technical specifications and safety profile of the device aligning with regulated standards and the predicate device.

8. The sample size for the training set

Not applicable. As this 510(k) is for an ultrasound imaging system and not for an AI/ML-driven device or an algorithm requiring a training set, no information about a training set size is provided.

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

Not applicable, as there was no training set.

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The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

Specific clinical applications and exam types include:

Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostrate)
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Peripheral vessel
Dermatological

The Vevo MD system is a high frequency general purpose, software controlled, diagnostic Imaging System used to acquire and display high-resolution, real-time ultrasound data in 2D, Color Doppler, and M-Mode. The Vevo MD System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

The provided text describes the FUJIFILM SonoSite Vevo MD Imaging System, an ultrasonic pulsed doppler imaging system, and the rationale for its substantial equivalence to predicate devices, rather than detailing a specific study to prove its performance against acceptance criteria for a new AI/CAD device.

The document states that "The Vevo MD Imaging System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This indicates that no specific performance study, as typically described for AI/CAD devices, was conducted or presented in this submission to demonstrate the device meets new acceptance criteria. Instead, the submission relies on the device's technological similarity and compliance with safety standards to established predicate devices.

Therefore, many of the requested categories regarding acceptance criteria and performance study specifics cannot be extracted directly from this document.

However, I can provide information based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no specific performance study against new acceptance criteria is presented, a direct table cannot be created. The document focuses on showing the device's intended use and technical specifications are similar to legally marketed predicate devices, implying that their established performance is the "acceptance criterion" for substantial equivalence.

(Matches the specific clinical applications of the predicate devices and is consistent with traditional clinical practice and FDA guidance.) |
| Technological Characteristics: Comparable modes of operation (2D, M-mode, Color Doppler), frequency range, and digital channel count to predicate devices. | Modes of Operation: B-mode (2-D Grayscale Imaging), M-mode, Color Doppler, Combination Modes (B(2D)+CD, B(2D)+M).
Transducer Center Frequency: 15-49 MHz.
Transmit Channels: 64 digital channels.
Receive Channels: 64 digital channels.

(These specifications are presented in comparison tables to demonstrate substantial equivalence to the SonoSite X-Porte ultrasound system (K133134) and EpiScan I-200 (K062571). While some differences exist (e.g., X-Porte has 128 transmit channels and additional modes), the submission argues for overall substantial equivalence.) |
| Safety and Effectiveness: Conformance to applicable mandatory medical device safety standards (electrical, thermal, mechanical, EMC, cleaning/disinfection, biocompatibility, acoustic output). | Compliance with Standards: Evaluated for electrical, thermal, mechanical, and EMC safety. Cleaning/disinfection, biocompatibility, and acoustic output evaluated. Conforms to applicable mandatory medical device safety standards and voluntary standards including ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004.
Biocompatibility: All patient contact materials are biocompatible and are either used in predicate devices or meet 10993 standards.
Quality Assurance: Established through Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation (this refers to the process verification, not a clinical study on patient outcomes). |
| Track: Classified as a Track 3 device, consistent with the primary predicate. | Track: Track 3 device.

(The predicate SonoSite X-Porte is also a Track 3 device, while the EpiScan I-200 is a Track 1 device, indicating a range of comparison.) |

The following points cannot be answered as the document explicitly states no clinical studies were required for this 510(k) submission to support the determination of substantial equivalence. The submission does not describe a performance study as typically seen for AI/CAD devices with new acceptance criteria.

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

• Not applicable as no performance study was conducted.

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

• Not applicable as no performance study was conducted.

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

• Not applicable as no performance study was conducted.

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:

• Not applicable as this is not an AI/CAD product and no comparative effectiveness study was done.

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

• Not applicable as this is not an AI/CAD product and no standalone performance study was done.

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

• Not applicable as no performance study was conducted. The ground truth for proving substantial equivalence relies on the established safety and efficacy of the predicate devices and the new device's compliance with engineering and safety standards.

8. The sample size for the training set:

• Not applicable as no AI/CAD model is discussed, and thus no training set.

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

• Not applicable as no AI/CAD model is discussed, and thus no training set.

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