(108 days)
MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigation, in operating rooms/critical care units.
MicrUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.
MicrUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The system is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 15 MHz.
The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, inclusive of the predicate devices so claimed.
The MicrUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the MicrUs via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived.
The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC.
The basic modification MicrUs EXT-1H ultrasound system utilizing as hardware and firmware an ultrasound engine contained in a small stand alone enclosure for connection to a host PC via a USB port.
The MicrUs can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes).
The provided text describes the MicrUs ultrasound imaging system and its intended use, as well as regulatory information from an FDA 510(k) premarket notification. However, it does not explicitly detail specific acceptance criteria or a study designed to prove the device meets performance criteria in the way a clinical performance study would for an AI/ML device.
This document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through new performance studies. The performance standards mentioned are related to safety and effectiveness broadly, not specifically to detailed clinical performance metrics like sensitivity or specificity for a diagnostic algorithm.
Therefore, many of the requested elements for describing acceptance criteria and a study proving their achievement are not present in the provided text.
Here's what can be extracted and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic AI/ML algorithm, nor does it report device performance against such criteria. The "performance standards" listed are related to general safety and operational standards (e.g., IEC, ISO, NEMA) rather than specific diagnostic performance metrics for an AI-powered diagnostic output.
| Acceptance Criteria (Quantitative Performance) | Reported Device Performance |
|---|---|
| Not specified for diagnostic performance | Not specified |
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/Not Provided. The document does not describe a test set or data derived from a clinical study to evaluate diagnostic performance. The submission is based on demonstrating substantial equivalence through compliance with safety standards and a comparison to predicate devices, not on a new clinical performance study.
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)
- Not Applicable/Not Provided. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. No test set requiring adjudication 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
- Not Applicable/Not Provided. The document is for an ultrasound imaging system, not an AI-assisted diagnostic tool requiring an MRMC study for improved human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. The device is an ultrasound imaging system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Not Provided. No ground truth data is discussed as there is no specific diagnostic performance study mentioned for a new diagnostic algorithm.
8. The sample size for the training set
- Not Applicable/Not Provided. The document describes an ultrasound imaging system, not an AI/ML device requiring a training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. No training set is discussed.
Summary from the provided text:
The MicrUs is an "ultrasonic pulsed echo imaging system" intended for various applications including fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic cardiac adult, and peripheral vessel imaging. It supports B and M-mode imaging, including for needle guidance. The submission focuses on demonstrating compliance with safety and effectiveness standards and substantial equivalence to predicate devices (TELEMED; Echo Blaster K102253).
The "Performance Standards" section (pages 9-10) lists the following criteria, which are primarily related to general safety and technical performance of the ultrasound device, not diagnostic accuracy metrics:
- IEC 60601-1: 2005 (General requirements for basic safety and essential performance)
- IEC 60601-1-2: 2007 (Electromagnetic compatibility)
- IEC 60601-2-37:2007 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment)
- ISO-10993-1:2009, ISO-10993-5, ISO-10993-10:2010 (Biological Evaluation of Medical Devices)
- IEC 62304: 2006 (Medical device software -- Software life cycle processes)
- NEMA UD 2-2004: 2003 (Acoustic Output Measurement Standard)
- NEMA UD 3-2004: 2004 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices)
- AIUM MUS: 2002 (Medical Ultrasound Safety)
- Essential Requirements of Council Directive 93/42/EEC (Medical Device Directive)
- Acoustic output "in accordance with ALARA principle (as low as reasonably achievable)" and below FDA recommended limits.
The document explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison." This reinforces that the submission is for an established technology proving equivalence, not for a new diagnostic algorithm requiring dedicated clinical performance studies with acceptance criteria for sensitivity/specificity/accuracy.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.