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510(k) Data Aggregation
(124 days)
Aixplorer**®MACH20, Aixplorer®**MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH 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 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.
The shearwave speed, beam attenuation, viscosity 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 and pediatric patients with liver disease.
The supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart-based ultrasound imaging systems 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, microconvex, 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), Mmode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography and Strain Elastography.
This document describes the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and their accessories. The devices are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, and Doppler fluid flow analysis of the human body. The submission is for a 510(k) premarket notification, seeking substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device and its transducers are based on demonstrating substantial equivalence to the predicate device (AIXPLORER® MACH 20, AIXPLORER® MACH 30 Ultrasound Diagnostic Systems, K191007). The reported device performance is that the new device is identical or has additions/improvements while maintaining the safety and effectiveness of the predicate.
| Feature/Criterion | Predicate Device (K191007) | New Device (K202455) | Performance |
|---|---|---|---|
| Classification Name | Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570) | Identical | The new devices have identical classification names, indicating they fall under the same regulatory categories. |
| Class | Class II | Identical | The new devices maintain the same Class II classification. |
| Intended Use | Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body | Identical | The intended use statement for diagnostic imaging, elasticity imaging, and fluid flow analysis is identical, confirming the new devices perform the same core functions. |
| General Description | General purpose, mobile, software controlled diagnostic ultrasound system. Acquires and displays ultrasound data in various modes. Consists of system console and transducer. | Identical | The general description of the system's physical characteristics and core functionality is identical. |
| Clinical Applications | Abdominal, Small organs, Musculoskeletal, Fetal, GYN, Cardiac (non-invasive), Adult and neonatal cephalic, Pediatric, Urology, Vascular, Peripheral vascular, Trans-rectal, Trans-vaginal. | Identical (with new indications for specific transducers - see details below) | The core clinical applications are identical. However, some transducers exhibit "new indications" (marked with 'N' in the tables for transducers L10-2, L18-5, C9-2X, C6-1X, E12-3, MC12-3, LV16-5, LH20-6, P5-1X), broadening the scope for specific modalities on those transducers. |
| Imaging Modes (Conventional) | B-Mode (Harmonic, Fundamental), M-Mode, PW, CW, Color Doppler, Amplitude Doppler, Microvascular (Angio PL.U.S) | Identical | All conventional imaging modes are identical. |
| Other Imaging Features | Spatial compounding, Panoramic, Contrast | Identical (Addition of Contrast availability on clinical applications) | The general features are identical, with the new device explicitly stating the addition of Contrast availability on clinical applications. |
| Combination of Modes | Available | Identical | The ability to combine modes is identical. |
| Elastography | ShearWave Elastography, Strain Elastography | Identical | Both ShearWave and Strain Elastography functions are identical. |
| Design (Cart, Controls) | Mobile cart based product with control panel and monitor; Typical ultrasound imaging controls (gain, depth mode select...). | Identical | The physical design regarding the cart and user controls is identical. |
| Biopsy Guide | Available | Identical | Biopsy guidance functionality is identical. |
| Acoustic Output | Yes, as per NEMA UD-3 | Identical | The acoustic output remains within FDA guidelines as per NEMA UD-3. |
| Patient Contact Materials | Yes, per ISO 10993-1 | Identical | Patient contact materials comply with ISO 10993-1. |
| Image Review, Measurement, Calculation, Report | Yes | Identical | Features for image review, measurement, calculation, and reporting are identical. |
| General Safety | Conforms to IEC60601-1, 60601-1-2, 60601-2-37 | Identical | Compliance with general safety standards is identical. |
| Labeling | Conforms to 21 CFR Part 801 | Identical | Labeling complies with 21 CFR Part 801. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document is a 510(k) summary for an ultrasound diagnostic system. It explicitly states in section 8: "A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence: Not applicable." This indicates that no clinical tests were performed or relied upon for this submission. Therefore, there is no test set sample size and no data provenance in terms of patient data from clinical studies for this specific submission to evaluate the AI's performance.
The submission focuses on non-clinical testing and comparison to a predicate device. The "new indications" for transducers are for established ultrasound modalities (e.g., CEUS, Strain Elastography, new quantification methods), not a novel AI-driven diagnostic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical studies with patient data were conducted or relied upon for this 510(k) submission, there were no experts used to establish ground truth for a test set. The evaluation was based on non-clinical engineering and performance testing to demonstrate substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
As no clinical test set was used, there was no adjudication method employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Not applicable" for clinical tests (Section 8). This type of study would involve human readers and their performance with and without AI assistance, which is outside the scope of this non-clinical submission for substantial equivalence based on technical specifications and functional equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe any specific "standalone" AI algorithm performance studies. While the devices include features like "ShearWave™ Elastography" and "Strain Elastography" which rely on sophisticated algorithms for tissue property assessment, these features were previously cleared on the predicate device (K191007) and are stated to be "Identical." The submission emphasizes functional equivalence and safety rather than novel AI performance claim. The new features for the AIXPLORER® MACH / SUPERSONIC MACH systems are "Vi PLUS" and "Att PLUS & SSp PLUS" for specific transducers (L10-2, C6-1X, C9-2X). These are described as measurements related to vascularization, microvascularization, perfusion, and attenuation/shear wave speed, which may involve advanced processing, but their standalone performance is not detailed in the context of a dedicated performance study against ground truth.
7. The Type of Ground Truth Used
Given the absence of clinical studies, there was no ground truth derived from expert consensus, pathology, or outcomes data in the context of this 510(k) submission. The "ground truth" for the non-clinical testing was defined by established engineering and performance standards (e.g., acoustic output measurements against NEMA standards, electrical safety against IEC standards) and comparison to the predicate device's established performance.
8. The Sample Size for the Training Set
Since no AI-specific clinical performance study for a novel algorithm was described, there is no information provided regarding a training set sample size. The submission is focused on demonstrating that the new device's technical specifications and functionality are substantially equivalent to a previously cleared predicate device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for a novel AI algorithm's clinical performance, this information is not applicable and not provided in the document.
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