(101 days)
The Diagnostic Ultrasound System Aplio i900 Model TUS-A1900, Aplio i800 Model TUS-A1800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatic), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler and Combination Dopler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V7.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz.
The document describes the validation of several AI/ML-based features within the Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0. The study aims to demonstrate that these new features are substantially equivalent to existing functionalities and improve workflow.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several AI/ML-based features. While the format isn't a single table, I can synthesize the information for each feature:
Feature: Auto Plane Detection
| Acceptance Criteria | Reported Device Performance |
|---|---|
| > 90% agreement with sonographer-selected cardiac chamber views for A4C/A3C/A2C/SAX | Achieved 97% average pass rate across the four views |
Feature: Quick Strain
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reduced operation time with significance level of 5% | Achieved an average 68% reduction in operation time. |
| All ICC(2,1) values > 0.75 (indicating minimal inter-operator variability for EDV, ESV, EF, GLS) | Demonstrated minimal inter-operator variability by adoption of two-way random effects, absolute agreement, single rater/measurement for ICC. The exact ICC values are not given, but it is stated they passed the criteria. |
| Calculated NRMSE for EDV, ESV, EF, and GLS 0.75 (indicating minimal inter-operator variability) | Demonstrated minimal inter-operator variability by two-way random effects, absolute agreement, single rater/measurement for ICC. The exact ICC values are not given, but it is stated they passed the criteria. |
| Calculated NRMSE results by three clinical sonographers 0.75 (indicating minimal inter-operator variability) | Demonstrated minimal inter-operator variability by two-way random effects, absolute agreement, single rater/measurement for ICC. The exact ICC values are not given, but it is stated they passed the criteria. |
| Calculated Doppler trace measurement results by three clinical sonographers |
§ 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.