(189 days)
The SonicEye® Dual-Array Ultrasound System is for use in B-mode (grayscale) imaging of human subjects in the following clinical applications: Fetal, Cardiac (adult and pediatric, Abdominal, Pediatric, Peripheral vessel, Musculoskeletal (conventional and superficial), Small parts (breast, thyroid, testes), Thoracic/pleural.
The device is intended for use by medical professionals to include doctors, imaging technicians, emergency medicine and military corpsmen/medics that have been trained in basic sonography techniques. The use would include medical environments such as hospitals, clinics, military field aid stations.
The SonicEye® Dual-Array Ultrasound System is a lightweight, battery-powered unit that contains an innovative dual-array fingertip transducer which incorporates two transducer arrays, a high-frequency linear and a low-frequency phased, in a single easily-controlled fingertip design that can be worn on the fingertip or held between the thumb and forefinger like most ultrasound probes.
The transducer is hard-wired to an image processor module that is firmware controlled. The image processor controls the behavior of the device including; beamforming, image construction, and power management; and transmits acquired data via USB cable to a computer tablet, with proprietary SonicEye Application software installed. The Windows application allow the operator to view scanned images and to control the user-selectable features of the device.
The system operates in B-Mode ONLY.
Here's a breakdown of the acceptance criteria and study information for the SonicEye® Dual-Array Ultrasound System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define quantitative "acceptance criteria" for the device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for a particular clinical task). Instead, the performance summary focuses on meeting general medical device standards and demonstrating non-inferiority to a predicate device in a specific use case.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence | "Both products employ the same technological features: the use of piezo-electric transducers to project focused beams of ultrasound enerqy into the human body then process the characteristics of the returned echo to create an image of soft tissues." |
| Compliance with Standards | The SonicEye system meets ISO 10993-1 (Biocompatibility), IEC 60601-1 (Electrical Safety), IEC 60601-2-37 (Ultrasonic Medical Diagnostic Equipment Safety), IEC 60601-1-2 (EMC), NEMA UD 2 (Acoustic Output), and ISO 14971 (Risk Management). |
| Clinical Performance (eFAST) | "The study concluded that the performance of the medics did not differ between the use of the SonicEye and the GE Vscan." (Implies non-inferiority to predicate for this application by specific users) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text doesn't explicitly state the exact number of "live humans" or "simulation models" used in the eFAST study. It refers to "study volunteers included both men and women, ages 18-54 years" for the live human component.
- Sample Size (Test Set): Not explicitly stated numbers for "live humans" and "simulation models."
- Data Provenance: Prospective, randomized, crossover trial. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not provide any information regarding the establishment of ground truth for the eFAST study. It focuses on the performance of combat medics using the devices, not on how the actual trauma findings (ground truth) were determined.
4. Adjudication Method for the Test Set
The text does not provide any information about the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- A comparative effectiveness study was done.
- Effect Size: Not explicitly stated as a quantitative effect size in terms of reader improvement. The conclusion given is: "The study concluded that the performance of the medics did not differ between the use of the SonicEye and the GE Vscan." This implies no significant difference or improvement was observed between the two devices in the context of combat medic performance in eFAST. This was a comparison between two devices, not between AI assistance and no AI assistance. The SonicEye is an ultrasound system, not an AI-powered diagnostic tool as described in typical MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of the SonicEye device as described. The SonicEye is an ultrasound imaging system, not an AI algorithm that generates diagnoses independently. The clinical study evaluated human users (medics) operating the device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The text does not provide any information about the type of ground truth used for the eFAST study (e.g., whether it was based on subsequent imaging, surgical findings,
clinical outcomes, or expert consensus on the simulation models).
8. The Sample Size for the Training Set
The text does not mention any training set or machine learning components for the SonicEye system. The device is described as firmware-controlled and operating in B-mode, implying traditional ultrasound functionality rather than an AI/ML-driven diagnostic system that requires a separate training set of labeled data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as no training set for an AI/ML component is mentioned.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.