(192 days)
The SuperSonic Imagine AIXPLORER® 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 ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-CYN, Pelvic, Pediatric, Urology, Transrectal, 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:
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Measurements of abdominal anatomical structures,
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Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
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Measurements of brightness ratio between liver and kidney,
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Visualization of abdominal vascularization, microvascularization and perfusion,
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Quantification of abdominal vascularization and perfusion.
The shearwave speed, beam attenuation, viscosity and stiffness measurements, 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 SuperSonic Imagine AIXPLORER® 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, 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-Color Flow Imaging, CPI-Color Power 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 ShearWaye™ elastography and Strain Elastography.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on establishing substantial equivalence for the AIXPLORER® MACH 30 and AIXPLORER® MACH 20 Ultrasound Diagnostic Systems to predicate devices. It doesn't explicitly state numerical acceptance criteria in the format of a performance table like sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the new device performs at least as safely and effectively as the predicate devices and complies with relevant regulatory standards.
The device performance is demonstrated through compliance with a set of international and FDA-recognized standards and through a comparative engineering test.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with electrical, basic safety, essential performance, electromagnetic compatibility, and acoustic output standards. Biocompatibility of patient contact materials. | "All applicable electrical, basic safety and essential performance tests," "All applicable testing pertaining to electromagnetic compatibility," "All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment" (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37). "Yes, per ISO 10993-1" for patient contact materials. "Yes, as per NEMA UD-3" for acoustic output within FDA guidelines. |
| Effectiveness | Performance according to intended use for various clinical applications and imaging modes. Substantial equivalence in imaging modes and measurements, including new indications (Vi PLUS, Att PLUS, SSp PLUS, Strain Elastography). | "The Aixplorer® MACH Systems perform according to the stated intended use." "Engineering test of Strain Elastography between Aixplorer® MACH and Mindray Resona 7 confirms the equivalence between Aixplorer® MACH and its predicate Mindray Resona 7 on a quantitative and qualitative side." The device tables indicate "New" for Vi PLUS, Att PLUS, and SSp PLUS modalities, implying their successful implementation and functionality. |
| Labeling | Conformance to 21 CFR Part 801. | "Conforms to 21 CFR Part 801." |
| Quality System | Compliance with 21 CFR Part 820 and ISO 13485 (2016). | "The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention "test set" in the context of clinical images or patient data for evaluating AI performance. The studies described are primarily non-clinical engineering and regulatory compliance tests.
For the Strain Elastography engineering test, a specific sample size of cases or patients is not provided. It mentions a comparison "between Aixplorer® MACH and Mindray Resona 7," implying a technical evaluation rather than a clinical study with a patient cohort.
Data Provenance: Not applicable in the context of detailed clinical study data for AI performance. The regulatory compliance testing refers to international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the primary evidence cited is non-clinical engineering tests and adherence to standards, there is no mention of "experts" establishing ground truth for a clinical test set in the conventional sense of human readers. The "ground truth" for the engineering tests would be derived from the specifications and established performance of the predicate device and the physical principles verified by the tests themselves.
4. Adjudication Method for the Test Set
Not applicable, as a clinical test set with human readers and adjudication is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The submission focuses on establishing substantial equivalence to predicate devices for the ultrasound system itself and new indications, rather than the performance of AI-assisted interpretation by human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm-only performance study is explicitly mentioned. The "AIXPLORER® MACH" systems themselves perform diagnostic ultrasound imaging, and newer functionalities like "Vi PLUS," "Att PLUS," and "SSp PLUS" are described as features of the diagnostic system, not necessarily as standalone AI algorithms for image interpretation or diagnosis. The "engineering test of Strain Elastography" compares the device's technical output to a predicate, not an AI algorithm's diagnostic output.
7. The Type of Ground Truth Used
For the engineering tests and compliance studies, the "ground truth" is based on:
- Regulatory Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-1. These standards define the acceptable technical and safety performance.
- Predicate Device Performance: The performance of the predicate ultrasound systems (AIXPLORER® MACH range sw V1, Aplio i900, i800, i700 V2.0, Resona 7) serves as the benchmark for "equivalence" in aspects like imaging modes and intended use.
- Physical Measurements and Quantitative/Qualitative Comparison: For the Strain Elastography test, the ground truth would be the known and verifiable measurements and output of the predicate Mindray Resona 7.
8. The Sample Size for the Training Set
No information about a training set for an AI/algorithm is provided. The document describes a medical device (ultrasound system) that relies on engineering principles and established imaging techniques, not a deep learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/algorithm is mentioned.
§ 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.