(85 days)
The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for:
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Measurements of abdominal anatomical structures,
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Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
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Measurements of brightness ratio between liver and kidney,
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Visualization of abdominal vascularization, microvascularization and perfusion,
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Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,
microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.
The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
The provided document is a 510(k) Summary for the SuperSonic Imagine AIXPLORER® MACH Ultrasound Diagnostic Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by non-clinical testing and clinical evaluation via literature review. No primary clinical study data with specific acceptance criteria and detailed performance metrics of the device are present in this document.
Therefore, many of your requested details cannot be extracted from this specific 510(k) summary as it does not contain a primary clinical study description with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case study data.
Here's a breakdown of what can be extracted and what information is not available from this document:
1. A table of acceptance criteria and the reported device performance
- Not Available. This document does not specify quantitative acceptance criteria for device performance nor does it report specific performance metrics from a clinical study for the AIXPLORER® MACH systems.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document states that a "clinical evaluation by literature route" was performed, indicating no new primary clinical test set was used for the AIXPLORER® MACH device for this submission.
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 Available. Since no new primary clinical test set was used, there is no information on experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. As no new primary clinical test set was used, no adjudication method is mentioned.
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 Available. This document does not describe an MRMC comparative effectiveness study. The AIXPLORER® MACH is an ultrasound diagnostic system and is not presented as an AI-assisted reading device in this context. The "AIXPLORER® MACH" name refers to the product family and not necessarily a specific AI algorithmic component for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available. This document describes an ultrasound diagnostic system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. Since no new primary clinical study was conducted for this submission, no specific ground truth type is mentioned for a test set. The clinical evaluation relied on literature, implying that existing, previously established diagnostic methods or outcomes referenced in that literature would have served as de facto ground truth for those earlier studies.
8. The sample size for the training set
- Not Applicable / Not Available. This document describes the 510(k) clearance for an ultrasound diagnostic system, which is a hardware and software system for image acquisition and display, not a machine learning algorithm requiring a "training set" in the typical sense. Any internal algorithm development for image processing would not be detailed in this summary with specific training set sizes.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. See point 8.
Summary of available information regarding compliance and equivalence:
The document focuses on establishing substantial equivalence to previously cleared predicate devices:
Non-Clinical Testing:
Non-clinical testing was performed according to several international and FDA-recognized standards to support substantial equivalence:
- IEC 60601-1 Ed.3.1 (Electrical, basic safety, and essential performance)
- IEC 60601-1-2 Ed.4 (Electromagnetic compatibility)
- IEC 60601-2-37 Ed.2.1 (Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipment)
- NEMA UD 2 (Rev. 3) (Acoustic Output Measurement Standard)
- NEMA UD 3 (Rev. 2) (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
- ISO 10993-1 (Biocompatibility)
The document states: "All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s)."
Clinical Evaluation:
A clinical evaluation was conducted "by literature route" to support substantial equivalence and to potentially expand the indications for use. This means existing scientific literature and studies related to similar ultrasound technologies and their clinical performance were reviewed, rather than conducting a new, dedicated clinical trial for the AIXPLORER® MACH systems themselves.
Conclusion stated in the document:
"The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed in item 3."
§ 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.