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510(k) Data Aggregation
(104 days)
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
The Diaqnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indicated for the visualization of structures, and dynamic processes with the human body usinq ultrasound and to provide image information for diaqnosis in the followinq clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-A1600, V2.4 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.
This document describes the Toshiba Medical Systems Corporation Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4, a modified device, and compares it to a predicate device (Aplio i900/i800/i700, V2.1, K163702).
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The device is substantially equivalent to its predicate device and offers several new features and improvements. Acceptance criteria are typically defined by demonstrating substantial equivalence to a legally marketed predicate device and meeting performance specifications through testing.
Specific performance assessments for new and improved features include:
| Feature/Metric | Acceptance Criteria (Demonstrated Equivalency/Performance) | Reported Device Performance |
|---|---|---|
| 3D Wall Motion Tracking (LV Analysis) | Equivalency in volume measurement (EDV/ESV/EF) and strain measurement (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain, Global Radial Strain) compared to predicate devices. | Demonstrated equivalency in volume and strain measurements. The implemented 3D WMT features enabled cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis and display of three analysis features simultaneously. |
| 3D Wall Motion Tracking (LA Analysis) | Equivalency in volume measurement (EDV/ESV or Vmax/Vmin) and strain measurement (Global Area Change Ratio, Global Longitudinal Strain and Global Circumference Strain) compared to predicate devices. | Demonstrated equivalency in volume and strain measurements. The implemented 3D WMT features enabled cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis and display of three analysis features simultaneously. |
| 3D Wall Motion Tracking (RV Analysis) | Equivalency in strain measurement (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain) and a Correlation coefficient (r) >= 0.90 with n=11 for volume measurement (EDV/ESV/EF) to the predicate function (Vivid E9, K131514 with GE EchoPAC, K120221). | Demonstrated equivalency in strain measurements and a correlation coefficient (r) >= 0.90 for volume measurement. The implemented 3D WMT features enabled cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis and display of three analysis features simultaneously. |
| Auto-EF | Demonstrated reduction in operation time for tracing (full-assist function) and appropriate clinical measurements. | Full-assist function for tracing showed reduced operation time compared to the predicate device to obtain EDV/ESV/EF and Global Longitudinal Strain. Clinical evaluation demonstrated appropriate clinical measurements. |
| 3D ACM | Function correctly measures flow volume and meets performance specifications. | Pulsating flow phantom study demonstrated that flow volume measurement met performance specifications as expected. |
| Z-Score Measurement | Function correctly calculates and provides the correct Z-score for cardiac structures (Aortic valve, Pulmonary valve) based on pre-obtained values of femur length (FL), biparietal diameter (BPD), or gestational age (GA) using fetal echocardiography. | Bench study using previously acquired fetal ultrasound data demonstrated correct Z-score calculation for cardiac structures based on provided parameters. |
| MPI Measurement | Function correctly measures velocity at an ROI to provide a graph of time variation of the velocity TIC, correctly measures time duration between two points on TIC, and correctly calculates MPI from these durations. | Bench study using Doppler phantom demonstrated correct velocity measurement and TIC generation, correct measurement of time duration, and correct MPI calculation. |
| Mitral Valve Analysis (MVA) | Function demonstrates basic function and performance in vivo regarding visualization of mitral valve anatomy, surrounding structures, spatial relationship, and components (annulus, leaflets, segmentation line, commissures). Acceptance also includes image quality, measurement, workflow improvement, and interoperator variability. Measurement items to meet specified criteria compared to CT images. | Side-by-side comparison of 70 patients showed substantial equivalency in basic function, performance, visualization, image quality, measurement, workflow improvement, and interoperator variability. Cardiac phantom study confirmed MVA software met specified criteria for measurement items compared to CT image measurements. |
| 4D Imaging for 2D Array Transducers | Function correctly depicts shapes and flow within a phantom and performs as intended in clinical images on volunteers. | Bench testing with a phantom demonstrated correct depiction of shapes and flow. Clinical images on volunteers confirmed the function performs as intended. |
| Improvements to Existing Features | Improvements to Slice Thickness Control, Auto Volume Measurement, High Frame Rate CHI, 4D CHI, 4D ADF/SMI, iSMI, ECG Sync Acquisition (Shear Wave Elastography), ECG Sync Construction (Sensor 3D), Smart Fusion, 2D WMT (2D Array transducer use), Shear Wave Elastography, and Shear Wave Dispersion Map meet specifications and perform as intended. | Studies demonstrated that these improvements met specifications and performed as intended through phantom and volunteer studies. |
2. Sample Size Used for the Test Set and Data Provenance
- 3D Wall Motion Tracking (RV Analysis): n=11 for the correlation coefficient for volume measurement.
- Mitral Valve Analysis (MVA): Seventy (70) patients were included in a side-by-side comparison study. A cardiac phantom was also used.
- Auto-EF: A group of three volunteers for workflow improvement assessment. A clinical evaluation was also conducted (sample size not specified).
- Z-Score Measurement: Previously acquired fetal ultrasound data. (Sample size not specified)
- 4D Imaging for 2D Array transducers: Phantom studies and volunteer studies (number of volunteers not specified).
- Improvements to existing features: Phantom and volunteer studies (sample sizes not specified).
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" for most studies. However, the mention of "previously acquired fetal ultrasound data" for Z-Score implies retrospective data for that specific test. The mention of "volunteers" and "patients" suggests prospective data for other tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
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
The document does not explicitly describe an MRMC comparative effectiveness study where human readers improve with AI assistance. The testing focuses on the device's performance against predicate devices or pre-defined performance metrics, but not on human-AI collaboration.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The studies conducted for Auto-EF, 3D ACM, Z-Score Measurement, and MPI Measurement appear to be standalone tests of the algorithm's performance against defined criteria or phantoms. While Auto-EF also involved an assessment of workflow improvement with volunteers, the core performance checks for these features seem to be standalone.
7. The Type of Ground Truth Used
- 3D Wall Motion Tracking (RV Analysis): Comparison to the predicate function (Vivid E9, K131514 with GE EchoPAC, K120221).
- Auto-EF: "Appropriate clinical measurements" as expected.
- 3D ACM: Performance specifications for flow volume measurement using a pulsating flow phantom.
- Z-Score Measurement: Pre-obtained values of femur length (FL), biparietal diameter (BPD), or gestational age (GA) using fetal echocardiography.
- MPI Measurement: Correct measurement of velocity and time durations in a Doppler phantom, and correct MPI calculation according to predefined methods.
- Mitral Valve Analysis (MVA):
- In vivo evaluation: "Basic function and performance" in visualization, measurements, workflow improvement, and interoperator variability using 70 patients.
- Phantom study: Comparison of MVA software output measurements to equivalent parameters obtained from a Computed Tomography (CT) system.
- 4D Imaging for 2D Array transducers: Correct depiction of shapes and flow in a phantom, and performance "as intended" in clinical images on volunteers.
8. The Sample Size for the Training Set
This information is not provided in the given text. The document describes verification and validation testing, but not details about model training.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the given text, as training set details are absent.
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