(71 days)
The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal Cephalic.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal, Neonatal Cephalic, Fetal/Obstetrics).
The SuperSonic Imagine AIXPLORER® system is 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 array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with inteorated 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, caplure 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 for the imaging modes: B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.
The provided 510(k) submission (K132171) for the SuperSonic Imagine AIXPLORER® ultrasound system does not include a clinical study with acceptance criteria for device performance in the sense of an AI/human reader comparative effectiveness study, or standalone algorithm performance.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to performance standards for a general-purpose ultrasound system. The device itself is an ultrasound imaging system, not an AI-powered diagnostic tool with specific performance metrics like sensitivity or specificity for disease detection.
Here's an breakdown of the information provided based on your request, highlighting what is (and isn't) present:
Acceptance Criteria and Device Performance Study for SuperSonic Imagine AIXPLORER® Ultrasound System (K132171)
1. A table of acceptance criteria and the reported device performance
There are no specific quantitative acceptance criteria or reported device performance metrics in the provided document that would typically be found for an AI-enabled diagnostic device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly met by demonstrating compliance with various industry standards and showing the device performs similarly to predicate devices across various imaging modes and applications.
The document states: "All data fell within pre-determined product specifications and external standard requirements." The study thus demonstrates that the new device's performance aligns with these established standards and its predicate's characteristics.
Implicit Acceptance Criteria and Reported Device Performance (Compliance with Standards):
| Acceptance Criteria (Implied) | Reported Device Performance (Compliance Status) |
|---|---|
| Compliance with IEC 60601-1 3rd Edition (Electrical safety) | All applicable tests passed. |
| Compliance with UL 60601-1 1st Edition (Electrical safety, USA) | All applicable tests passed. |
| Compliance with IEC 60601-1-1 2nd Edition (Medical systems) | All applicable tests passed. |
| Compliance with IEC 60601-1-2 3rd Edition (EMC) | All applicable tests passed. |
| Compliance with IEC 60601-2-37 2nd Edition (Safety of ultrasonic diagnostic equipment) | All applicable tests passed. |
| Compliance with NEMA UD 2 (Rev. 3) (Acoustic Output Measurement) | All applicable tests passed. |
| Compliance with NEMA UD 3 (Rev. 2) (Real Time Display of Acoustic Output Indices) | All applicable tests passed. |
| Compliance with ISO 10993-1 (Biocompatibility) | Applicable tests passed. |
| Performance of Fetal/Obstetrics features | Confirmed by performance tests. |
| Equivalence in Intended Use and Imaging Modes to Predicate Devices (K121329, K112255, K072786, K093563) | Demonstrated through comparative tables and functional descriptions. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical data is not required as the Aixplorer System uses the same technology and principles as predicate devices." Therefore, there is no test set of clinical data from patients and no information on data provenance. The testing conducted was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical test set was used, there were no experts involved in establishing ground truth for a test set. The validation relies on technical compliance with standards and comparison to predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As there was no clinical test set and no ground truth established by experts, no adjudication method was employed.
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
No MRMC comparative effectiveness study was performed or is mentioned. The device is a general-purpose ultrasound system, and the submission does not describe any AI-assisted features that would necessitate such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The submission solely focuses on the performance of the ultrasound system itself in terms of technical specifications and safety standards, as it is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was defined by established technical standards and specifications (e.g., acoustic output limits, electrical safety parameters, biocompatibility requirements) and the characteristics of the predicate devices. There was no clinical ground truth established from patient data.
8. The sample size for the training set
Not applicable. This device is an ultrasound imaging system, not an AI/machine learning algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. As above, there was no training set.
§ 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.