(103 days)
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate 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® & AIXPLORER® Ultimate 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, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and associated transducers are intended for: - Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the spleen,- Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.
The SuperSonic Inagine AIXPLORER® & AIXPLORER® Utimate systems are a cart based ultrasound imaging system used to perform noninvasive diagnostic general purpose ultrasing 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 aqustable control panel with integrated touch the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in 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 CFF-ColorFlow Imaging, CP-ColorPower Imaging- aso called Amplitude Dopper, dCP-drectional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
Here's an analysis of the acceptance criteria and supporting studies for the AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining new, specific performance metrics with acceptance criteria for an AI component. The device is a general-purpose ultrasound system with several imaging modes, including ShearWave™ Elastography, and features for vascularization and perfusion.
The document states that a "clinical evaluation by literature route" was performed to support substantial equivalence and to widen the indications for use. This suggests reliance on existing published data about the performance of ultrasound systems with similar functionalities, particularly ShearWave™ Elastography, rather than a new performance study with predefined acceptance criteria.
Therefore, a table of acceptance criteria and reported device performance directly from a standalone AI study is not present in this document. Instead, the "reported device performance" is implicitly that the device is "at least as safe and effective as the predicate devices" based on non-clinical testing and clinical literature review.
However, the "Indications for Use" section (pages 2-14) outlines the specific capabilities of the AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems, particularly emphasizing:
- Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen.
- Measurements of brightness ratio between liver and kidney.
- Visualization of abdominal vascularization, microvascularization and perfusion.
- Quantification of abdominal vascularization and perfusion.
These capabilities, particularly the ShearWave™ Elastography, visualization, and quantification of vascularization/perfusion, represent the "performance" that is being claimed as substantially equivalent to the predicate devices. The implicit acceptance criteria are that these functions operate within expected diagnostic ranges and provide information comparable to or better than the predicate devices, as supported by the literature review.
Specific Study Information from the Text:
-
A table of acceptance criteria and the reported device performance:
As mentioned above, specific quantitative acceptance criteria or a direct performance table for a new AI feature is not provided. The entire submission focuses on establishing substantial equivalence to existing ultrasound devices (K171105, K170445, K160524) for its various imaging modes, including ShearWave™ Elastography and vascularization/perfusion features. The performance is validated indirectly through non-clinical testing against industry standards and a clinical literature review. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions a "clinical evaluation by literature route," which implies no specific new test set was generated for this submission. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature of a dedicated test set is not provided. The data would originate from the cited literature. -
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):
Since there was no specific new test set to establish ground truth for this submission, this information is not applicable and not provided in the document. The "ground truth" for the literary review would be inherent to the studies cited, established by the experts in those original publications. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new test set with human adjudication was created for this submission. -
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:
No MRMC study is mentioned. The submission focuses on the device itself and its equivalence to other devices, not specifically on human reader improvement with AI assistance. The term "AI" is not explicitly used to describe the ShearWave Elastography or vascularization quantification features, although these advanced image analysis techniques often incorporate intelligent algorithms. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes an ultrasound system (hardware and software) used for diagnostic imaging, with features like ShearWave™ Elastography, vascularization visualization, and quantification. These are integrated functions of the device. There is no mention of a separate "algorithm only" performance study. The device, as a whole, performs these measurements and displays the results for interpretation by a human clinician. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "clinical evaluation by literature route," the ground truth would depend on the methodologies of the individual studies cited in the literature. These could include pathology, clinical follow-up, or expert consensus, but this document does not specify the type of ground truth used in the underlying scientific literature. -
The sample size for the training set:
As this is a premarket notification for device equivalence and not a submission detailing the development of a novel machine learning algorithm that requires a dedicated training set, no information about a training set size is provided. The device's algorithms for ShearWave™ Elastography, vascularization, and perfusion would have been developed and validated internally by the manufacturer, presumably using relevant data, but details about such training are not part of this 510(k) summary. -
How the ground truth for the training set was established:
Not applicable, as no training set information is provided in this regulatory submission.
§ 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.