(114 days)
The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications:
Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies). Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.
Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep.
The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic. hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.
The Butterfly iQ3 Ultrasound System is a portable, hand-held, general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging.
The user interface includes touch screen menus, buttons, controls, indication icons that allow the operator to control the system and to view and measure ultrasound imagerv.
The provided text is a 510(k) summary for the Butterfly iQ3 Ultrasound System. This document does not describe acceptance criteria for an AI/CADe device or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate ultrasound system (Butterfly iQ/iQ+ Ultrasound System, K220068) based on technological characteristics and non-clinical performance testing of the ultrasound system itself.
Here's why the requested information cannot be extracted from this document:
- No AI/CADe Acceptance Criteria: The document describes a general diagnostic ultrasound imaging system. While it mentions the "Bladder Volume and B-lines tools remain compatible with the images generated with the iQ3," these are presented as features of the ultrasound system's software compatibility, not as separate AI/CADe functions with specific performance acceptance criteria. There's no mention of a standalone AI algorithm, human-in-the-loop performance, or specific metrics like sensitivity, specificity, or AUC that would be associated with an AI/CADe device.
- No Clinical Study for Substantial Equivalence: The document explicitly states: "The Butterfly iQ3 Ultrasound System did not require clinical studies to support substantial equivalence for this premarket submission." This indicates that the substantial equivalence was demonstrated through non-clinical testing (e.g., electrical safety, biocompatibility, mechanical safety, software verification and validation) and comparison of technical specifications to the predicate device, not through a clinical performance study involving human readers or AI algorithms with associated ground truth.
- No Ground Truth Information: Since no clinical studies were performed, there is no discussion of how ground truth was established, the number of experts, their qualifications, or adjudication methods.
- No Training Set Information: Without a clinical performance study involving AI/CADe, there's no mention of a training set or how its ground truth was established.
Therefore, based on the provided text, it is not possible to fill out the requested table or answer the specific questions about acceptance criteria, clinical study details, sample sizes, expert involvement, or ground truth for an AI/CADe device.
The document primarily focuses on demonstrating that the Butterfly iQ3 Ultrasound System, as a whole, is safe and effective and substantially equivalent to its predecessor for various human body applications, based on its hardware and software functionalities for image acquisition and display, not on the performance of a specific AI algorithm designed to interpret those images for diagnostic purposes.
§ 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.