(40 days)
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.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (FUJIFILM SonoSite Vevo MD Imaging System) |
|---|---|
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for specific clinical applications (Abdominal, Pediatric, Small Organ, Musculoskeletal (Conventional & Superficial), Peripheral vessel, Dermatological). | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Abdominal, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel, Dermatological. |
(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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.