(86 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, GYN, Pelvic, Pediatric, Urology, Trans-rectal and Trans-vaginal.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatic, Urology, Transrectal and Trans-vaginal).
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 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, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Dopler, 3D imaging and for ShearWave™ elastography.
This document is a 510(k) summary for the SuperSonic Imagine AIXPLORER® ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for new device performance.
Therefore, many of the requested items (like specific acceptance criteria, sample sizes for test/training sets, number of experts, adjudication methods for ground truth, MRMC studies, and standalone performance) are not detailed in this document because the submission is for a general-purpose ultrasound system showing equivalence rather than a device claiming improved diagnostic performance for specific conditions through new algorithms or features.
However, I can extract the information that is present and explicitly state when information is not available in the provided text.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy for specific clinical tasks, as it's a submission for a general-purpose ultrasound system establishing substantial equivalence. The "performance" mentioned is primarily related to safety and the functional equivalence of imaging modes and capabilities to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Safety - Acoustic Output Limits | Mechanical Index: 1.9 (Maximum) |
| TIS/TIB: 0.1 - 4.0 (Range) | |
| ISPTA(d): 720 mW/cm2 | |
| ISPPA(d): 0 - 700 W/cm2 | |
| "These limits are the same as predicate Track 3 devices." | |
| Safety - Electrical & Physical | "Designed to comply with IEC 60101-1 (2005) and IEC 60601-2-37 (2007)." |
| Functional Equivalence (Overall) | "Substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, safety and effectiveness." |
| Clinical Capabilities | Same B-Mode (grayscale imaging) and Doppler capabilities as predicates. |
| Similar harmonic imaging, spatial compound imaging, elastography imaging, and other image post-processing features to predicates. | |
| Material Safety | "Manufactured with materials which have been evaluated and found to be safe for the intended use of the device." |
| Measurement, Capture, Reporting | Similar capability to predicate devices for performing measurements, capturing digital images, reviewing, and reporting studies. |
| Manufacturing Compliance | "Manufactured in compliance with approved electrical and physical safety standards." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this is a 510(k) submission primarily demonstrating substantial equivalence to predicate devices based on functional and safety characteristics, it doesn't detail a specific clinical trial with a "test set" in the context of diagnostic accuracy for a new feature. The ShearWave™ elastography mentioned is established as being "similar in capabilities" to predicate devices, rather than through a new, specific clinical performance study with a defined test set.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication that an MRMC comparative effectiveness study was done. The document focuses on the AIXPLORER® system itself and its equivalence to other ultrasound systems, not on an AI-assisted interpretation component for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not describe performance of an algorithm only in a standalone capacity. The AIXPLORER® is a diagnostic ultrasound system intended for human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Given the nature of a general ultrasound system 510(k), explicit ground truth definition for a specific diagnostic task is typically not required for substantial equivalence, unless a new diagnostic algorithm with specific performance claims is being introduced.
8. The sample size for the training set
This information is not provided in the document. The document describes a general diagnostic ultrasound system; it does not detail the use or training of a specific AI algorithm.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.