(58 days)
ViewMate Multi Ultrasound System VMM-ICE-01 is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, thoracc, and vacular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac and Peripheral vessel exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, TDI, Color M.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
ViewMate™ Multi Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, TDI, Color M.
ViewMate™ Multi Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
This document is a 510(k) summary for the ViewMate™ Multi Ultrasound System and does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance.
Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, expert qualifications, and ground truth are not present in this regulatory document.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, rather than presenting specific performance metrics against defined acceptance criteria for a new device's core functionality.
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The document states "Non-clinical Tests" were performed, but does not detail a "test set" for performance evaluation in the context of clinical or diagnostic accuracy. It refers to testing against safety and performance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As clinical studies were deemed "Not applicable," there's no mention of experts establishing ground truth for a test set.
4. Adjudication method for the test set
This information is not provided in the document.
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
This information is not provided and is not applicable. The ViewMate™ Multi Ultrasound System is described as a "general purpose diagnostic ultrasound system" and there is no indication it incorporates Artificial Intelligence (AI) or machine learning features that would necessitate an MRMC comparative effectiveness study to assess human reader improvement with AI assistance. Clinical studies are explicitly stated as "Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. Based on the device description, it's a diagnostic ultrasound system intended for use by healthcare professionals, implying human-in-the-loop operation. There is no mention of a standalone algorithm for independent performance.
7. The type of ground truth used
This information is not provided and is not applicable as clinical studies were not performed. The testing mentioned (acoustic output, biocompatibility, safety standards) does not rely on a "ground truth" in the diagnostic sense (e.g., pathology, outcomes data).
8. The sample size for the training set
This information is not provided and is not applicable. Since clinical studies were not required, and there's no mention of AI/machine learning components that typically require training sets, this detail is absent.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as point 8.
Summary of what the document does provide regarding device evaluation:
The document indicates that the ViewMate™ Multi Ultrasound System underwent non-clinical tests to demonstrate its safety and effectiveness. These tests included:
- Acoustic output evaluation (against NEMA UD 2-2004 (R2009))
- Biocompatibility evaluation (against ISO 10993-1 Fifth edition 2018-08)
- Cleaning and disinfection effectiveness
- Thermal, electrical, and mechanical safety (against AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text), IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-2-37 Edition 2.1 2015)
- Software life cycle processes (against IEC 62304 Edition 1.1 2015-06)
- Usability engineering (against IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1 Edition 1.0 2015-02)
- Risk management (against ISO 14971 Third Edition 2019-12)
The "study" or evaluation performed was primarily a comparison against recognized industry standards and a predicate device (Resona I9 K210699) to establish substantial equivalence, rather than a clinical performance study with specific diagnostic accuracy or efficacy endpoints. The acceptance criteria for these non-clinical tests would be compliance with the requirements of the listed standards. For example, for acoustic output, the acceptance criterion would be that the acoustic power levels are "below the limits of FDA."
§ 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.