(389 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, Vasculoskeletal, 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, Peditatin, Uniology, 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 veriety of linear, curved, micro-convex, and motorized linear array intensducers to produce images that 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 diagnostics studies in the form of a report. The system functions in a manner identical to the predicate devices in the the imaging modes: B-Mode, Calleno in a mannel lucinical to the president for the imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided primarily relate to the non-clinical performance of the Shearwave™ elastography mode and are presented as bias and precision measurements compared to nominal shear wave velocities in a phantom. There are no explicit pass/fail thresholds defined in the text, so "acceptance criteria" here refers to the demonstrated performance that the manufacturer is submitting for equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Example for SLV16-5, 10.4mm target) |
|---|---|---|
| Shearwave Velocity Estimation Bias | Minimized, consistent | Target Type I: 6.4% |
| Target Type II: -8.6% | ||
| Target Type III: -3.2% | ||
| Target Type IV: 3.7% | ||
| Shearwave Velocity Estimation Precision | Minimized, consistent | Target Type I: 2.2% |
| Target Type II: 1.8% | ||
| Target Type III: 1.3% | ||
| Target Type IV: 0.9% | ||
| Depth Dependence of Shearwave Velocity | Satisfactory agreement across depths | Generally consistent Mean SWV (e.g., for SLV15-6: 2.86 m/s at 5mm, 2.70 m/s at 25mm) with low Standard Deviation (e.g., 0.01-0.05 m/s) |
| Acoustic Output Limits | Below FDA guideline limits | Mechanical Index: 1.9 (Max) |
| TIS/TIB: 0.1 - 4.0 (Range) | ||
| ISPTA(d): 720 mW/cm^2 | ||
| ISPPA(d): 0 - 700 W/cm^2 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The test set for "Bias and Precision of Shearwave Velocity Estimation" and "Depth Dependence of Elastography Velocity Estimation" consisted of a single CIRS 049A Quality Assurance elasticity phantom. This phantom contains stepped-cylinder targets of four stiffness types (I–IV) and varying diameters (4.1mm, 6.5mm, 10.4mm, 16.7mm).
- Sample Size for Measurements: For each target type and diameter within the phantom, five independent shear wave velocity measurements were performed to calculate bias and precision. For the depth dependence test, five measurements were performed per depth for the uniform-elasticity background material.
- Data Provenance: The data is non-clinical and was generated in a laboratory setting using a phantom, not from human subjects. The country of origin of the data is not explicitly stated, but the manufacturer is based in France and the data was submitted to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for the non-clinical tests was established by the nominal shear wave velocities of the CIRS 049A phantom, which are inherent properties of the phantom material as specified by the phantom manufacturer (CIRS).
- Qualifications of Experts: Not applicable, as no human experts were involved in establishing this type of ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" was the known nominal shear wave velocities of the phantom materials. The device's measurements were quantitatively compared against these known values. There was no expert consensus or adjudication process described as the ground truth was inherently defined by the phantom itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical performance data for the elastography mode and claims substantial equivalence to predicate devices based on identical intended use, imaging capabilities, safety, and effectiveness. The enhancement in this submission is merely a display change (a gradiated and adjustable numeric scale next to the color bar in elastography mode). Therefore, a study to measure human reader improvement with AI assistance (which ShearWave elastography is not explicitly described as, but rather an imaging mode) was not performed or necessary for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone performance assessment was effectively done for the elastography mode in a non-clinical setting. The tests for "Bias and Precision of Shearwave Velocity Estimation" and "Depth Dependence of Elastography Velocity Estimation" evaluate the algorithm's ability to accurately and precisely measure shear wave velocities in a phantom, independent of a human operator's interpretation. The results are quantitative measurements of the device's output (shearwave velocity estimates) against known phantom properties.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for the non-clinical performance tests was the nominal shear wave velocities provided by the manufacturer of the CIRS 049A Quality Assurance elasticity phantom. This represents a known, measurable physical property of the test material.
8. The Sample Size for the Training Set
- Not applicable / Not provided. This 510(k) summary does not describe any machine learning or AI algorithm that would require a distinct "training set" as understood in that context. The device is an ultrasound imaging system with an elastography mode, and the performance data presented is for the measurement capabilities of this established technology.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As no training set is described or implied for a machine learning component, the method for establishing its ground truth is not relevant to this 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.