MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/ AnesusME7T/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System is intended for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, transesoph( Cardiac) 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, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver). 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.
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/AnesusME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ ME8 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images.
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, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
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. The device can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
The provided text is a 510(k) summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and shared technological characteristics. Crucially, the document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
Therefore, a study demonstrating the device meets specific performance acceptance criteria for a diagnostic AI/CAD system with a test set, ground truth, and human reader comparative effectiveness was not performed or required for this submission. The device described is a general-purpose diagnostic ultrasound system, not an AI or CAD system with specific diagnostic performance metrics to meet.
Because no clinical study with acceptance criteria and reported performance was conducted, I cannot fill in the requested table or answer most of the follow-up questions related to such a study.
However, I can extract information regarding non-clinical acceptance criteria and the studies that prove the device meets these.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Non-Clinical Standard/Requirement) | Reported Device Performance (Compliance) |
|---|---|
| Acoustic output limits (UD 2-2004 (R2009)) | Below FDA limits, same as predicate. |
| Bio-compatibility | Evaluated. |
| Cleaning and disinfection effectiveness | Evaluated. |
| Thermal safety (ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]) | Conform with applicable medical safety standards. |
| Electrical safety (ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]) | Conform with applicable medical safety standards. |
| Mechanical safety (ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]) | Conform with applicable medical safety standards. |
| Electromagnetic compatibility (IEC 60601-1-2 Edition 4.1 2020-09) | Tested and evaluated. |
| Electromagnetic immunity (IEC TR 60601-4-2 Edition 1.0 2016-05) | Tested and evaluated. |
| Usability (IEC 60601-1-6 Edition 3.2 2020-07, IEC 62366-1 Edition 1.1 2020-06) | Tested and evaluated. |
| Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37 Edition 2.1 2015) | Tested and evaluated. |
| Risk management (ISO 14971 Third Edition 2019-12) | Applied. |
| Biological evaluation of medical devices (ISO 10993-1 Fifth edition 2018-08) | Applied. |
| Software life cycle processes (IEC 62304 Edition 1.1 2015-06) | Conforms. |
| Quality Management Systems (21 CFR 820, ISO 9001, ISO 13485) | Conforms. |
The following information is not applicable or not provided in the document for the reasons stated above (no clinical study performed):
- Sample size used for the test set and the data provenance: Not applicable, no clinical test set for diagnostic performance was used. The non-clinical tests relate to device safety and performance according to engineering standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical ground truth established.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a general diagnostic ultrasound system, not an AI/CAD system for interpretation or assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as this refers to a machine learning training set, which is not relevant for this general diagnostic ultrasound system's regulatory submission.
- How the ground truth for the training set was established: Not applicable.
§ 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.