(34 days)
The FUJIFILM SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Fetal - OB Abdominal Pediatric Cardiac Adult Cardiac Pediatric
The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.
This document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System, dated November 12, 2015. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, proven device performance through a study, expert involvement, and ground truth establishment is not present in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) or report quantitative device performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing intended use, technological characteristics, and conformance to recognized safety standards.
The closest to "acceptance criteria" are the standards it aims to comply with, listed in the "Summary of Non-Clinical Tests" section:
| Reference No. | Title |
|---|---|
| ISO 10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| IEC 60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 | AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3) |
| IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60601-2-37 | IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| IEC 62304 | AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycle processes |
| IEC 62359 | IEC 62359 Edition 2.0 2010-10-10, Ultrasonics – Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)] |
| ISO 14971 | ISO 14971:2007, Medical devices - Application of risk management to medical devices |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
The "reported device performance" is implicitly stated as "the device has been found to conform to applicable mandatory medical device safety standards" and "Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation."
2. Sample size used for the test set and the data provenance:
The document explicitly states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means there was no test set of patient data used for clinical performance evaluation. The evaluation was based on non-clinical tests (electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, acoustic output) and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical study was conducted using a test set of patient data, there were no experts involved in establishing ground truth for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set 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 ultrasound system, not an AI-powered image analysis tool that would typically be evaluated with MRMC studies for human reader improvement. The submission is for the base ultrasound system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a diagnostic ultrasound system intended for use by a "qualified physician and healthcare professionals," implying human operation and interpretation. It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No clinical ground truth was established from patient data. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the referenced standards.
8. The sample size for the training set:
Not applicable. This document describes a medical device clearance process based on substantial equivalence, not the training of an AI algorithm. There is no mention of a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an algorithm was mentioned or used for this submission.
In summary, the provided document is a 510(k) submission for an ultrasound system, demonstrating its safety and effectiveness through substantial equivalence to existing predicate devices and compliance with recognized industrial standards, rather than through clinical performance studies against specific acceptance criteria for diagnostic accuracy or through AI algorithm validation.
§ 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.