(89 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: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pediatric, Urology, Trans-rectal, Transvaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate are a cart based ultrasound imaging system 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, and Angio PL.U.S), Pulsed Wave Doppler, 3D imaging and for ShearWave™ elastography.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a device relying on AI. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing. The "reported device performance" is implicitly that it meets the same safety and performance standards as the predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Device Performance (Implicitly Met) |
|---|---|---|
| Safety | Compliance with IEC 60601-1, IEC 60601-1-2 | Met |
| Performance (Technical) | Compliance with IEC 60601-2-37, NEMA UD 2, NEMA UD 3 | Met |
| Biocompatibility | Compliance with ISO 10993-1 | Met |
| Intended Use | Capability to perform listed applications | Met |
| Technological Equivalence | Similar imaging modes, controls, transducers, etc. | Met |
| Acoustic Output | Within FDA guidelines | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical data is not required as the Aixplorer® and Aixplorer® Ultimate Systems use the same technology and principles as predicate devices." Therefore, no specific test set data (sample size or provenance) is provided for clinical performance, as a clinical study was not deemed necessary for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no clinical test set was submitted for the purpose of demonstrating substantial equivalence, there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no clinical test set was submitted, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on substantial equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an "Ultrasound Diagnostic System," which inherently involves a human operator to acquire and interpret images. While it includes "ShearWave™ elastography," which might involve some algorithmic processing, the document does not describe a standalone algorithm-only performance study for an AI component in isolation. The focus is on the integrated system.
7. Type of Ground Truth Used
Given that clinical data was not required for this submission, no specific ground truth (e.g., pathology, outcomes data, expert consensus) was referenced for a clinical study. The "ground truth" implicitly relied upon is the established safety and performance characteristics of the predicate ultrasound devices and the adherence of the new device to relevant international technical standards.
8. Sample Size for the Training Set
As there's no mention of an AI algorithm requiring a training set in the context of this 510(k) summary for clinical performance, no information on the sample size for a training set is provided. The submission focuses on device hardware and software equivalence to existing ultrasound technology.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of AI development for clinical performance, there is no information on how its ground truth would have been established.
§ 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.