(114 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, 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).
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 adiustable 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 for the imaging modes: B-Mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.
The provided 510(k) summary for the SuperSonic Imagine AIXPLORER® ultrasound system does not contain information about acceptance criteria or a specific study proving the device meets these criteria in the context of device performance metrics like sensitivity, specificity, or accuracy. This type of premarket notification primarily focuses on demonstrating substantial equivalence to predicate devices, and the submitted evidence is generally limited to non-clinical performance data and adherence to recognized standards.
Therefore, the requested information elements related to clinical study design, sample sizes for training/test sets, expert qualifications, and specific performance metrics cannot be extracted from this document, as they are not present.
The document emphasizes adherence to safety standards and comparison to predicate devices, rather than a clinical performance study with defined acceptance criteria and performance metrics.
Here's a breakdown of what can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to:
- Safety: Compliance with IEC 60601-1, UL 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 regarding electrical, basic safety, essential performance, and electromagnetic compatibility.
- Acoustic Output: Compliance with NEMA UD 2 and NEMA UD 3, and FDA guidance limits (September 9, 2008, 510(k) diagnostic ultrasound guidance) for Mechanical Index, TIS/TIB, ISPTA(d), and ISPPA(d).
- Biocompatibility: Compliance with ISO 10993-1.
- Functionality: Verification tests for "Panoramic" and "High PRF" features to ensure they "perform according to the stated intended use."
The document states: "All data fell within pre-determined product specifications and external standard requirements." However, it does not detail these "pre-determined product specifications" in a quantifiable manner for clinical performance.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. The document describes non-clinical performance testing against standards and feature verification, not a clinical study with a test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No clinical ground truth establishment or expert review for a test set is described.
4. Adjudication Method:
- Not applicable. No clinical study or adjudication process is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe a MRMC study or any comparative effectiveness study with human readers. The regulatory submission path chosen (510(k)) relies on substantial equivalence to predicate devices rather than a direct demonstration of clinical superiority or improvement with AI assistance.
6. Standalone (Algorithm Only) Performance:
- Yes, implicitly, for non-clinical aspects. The non-clinical performance data, particularly the "Panoramic Measurement Verification Tests" and "High PRF Measurement Verification Tests," represent testing of the device's algorithms/features in a standalone capacity (without human interaction) to ensure they function as intended per product specifications. However, this is not a clinical standalone performance evaluation for diagnostic accuracy.
7. Type of Ground Truth Used:
- For the non-clinical tests (e.g., Panoramic, High PRF verification), the "ground truth" would be the expected output or measurement values based on the device's design specifications and engineering principles. For compliance with standards, the ground truth is adherence to the technical requirements and limits defined by those standards.
8. Sample Size for the Training Set:
- Not applicable / Not provided. The device is a diagnostic ultrasound system, not an AI/ML device that typically involves a distinct "training set" in the context of learning algorithms for diagnostic tasks. Its functionality relies on established ultrasound physics and signal processing.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, a "training set" and associated ground truth for training are not relevant to the type of device and submission described here.
§ 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.