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510(k) Data Aggregation
(77 days)
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.
The provided 510(k) clearance letter and summary discuss the EchoPAC Software Only / EchoPAC Plug-in, including a new "AI Cardiac Auto Doppler" feature. The acceptance criteria and the study proving the device meets these criteria are primarily detailed for this AI-driven feature.
Here's an organized breakdown of the information:
1. Acceptance Criteria and Reported Device Performance (AI Cardiac Auto Doppler)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Feasibility score of more than 95% | The verification requirement included a step to check for a feasibility score of more than 95%. (Implies this was met for the AI Cardiac Auto Doppler). |
| Expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter. | The verification requirement included a step to check mean percent absolute error across all cardiac cycles against a threshold. All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. These results indicate that observed accuracy of each of the individual clinical parameters met the acceptance criteria. |
| For Tissue Doppler performance metric: Threshold not explicitly stated, but comparative values for BMI groups are provided. | **BMI |
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(86 days)
Vivid Pioneer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Vivid Pioneer is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications:
Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, Intra-luminal and Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural and Intraoperative (vascular).
Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor.
Vivid Pioneer includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices.
The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode-and operation dependent soft-keys.
The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers.
The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
This document describes the acceptance criteria and study proving the device meets the criteria for two AI features of the Vivid Pioneer Ultrasound System: AI Cardiac Auto Doppler and AI FlexiViews LAA.
1. Table of Acceptance Criteria and Reported Device Performance
AI Cardiac Auto Doppler
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Feasibility score of > 95% | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed the check for mean percent absolute error across all cardiac cycles against a threshold. This implies the accuracy threshold was met, which indirectly suggests successful feasibility to achieve this accuracy. |
| Expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter. | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. |
| Mean percent absolute error across all cardiac cycles against a threshold. | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. |
| Consistent model performance across BMI groups ( |
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(98 days)
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode. Color Doppler mode. Pulsed Wave (PW) Doppler mode. Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan™ Mode, MV-Flow Mode, Multi Image mode (Dual Quad) Combined modes 3D/AD model
The HERA Z20, R20, HERA Z30, R30 diagnostic ultrasound system are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, MV-Flow mode, Multi-Image mode(Dual, Quad), 3D/4D mode.
The HERA Z20, R20, HERA Z30, R30 diagnostic ultrasound system also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA Z20, R20, HERA Z30, R30 diagnostic ultrasound system have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's a summary of the acceptance criteria and the studies conducted for the AI-powered features of the HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System, based on the provided text.
This document describes several AI-powered features: Live ViewAssist, EzVolume, UterineContour, ViewAssist, HeartAssist, and BiometryAssist. Each feature has its own acceptance criteria and study findings.
1. A table of acceptance criteria and the reported device performance
Note: Some performance metrics were not explicitly stated as "acceptance criteria" but rather as "summary test statistics or other test results," indicating the device's measured performance against implicit or internal targets.
| AI Feature | Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Live ViewAssist | Quality assessment (Cohen's kappa) | Threshold 0.7 | Average Cohen's kappa coefficient: 0.818 |
| Time/duration (Frames per Second - FPS) | Threshold 20 FPS | Average speed: 30.06 FPS | |
| EzVolume | Acceptance Rate (segmentation) | Higher than 70% for each label | 1st Trimester: Fluid 98%, Fetus 96%, Umbilical-cord 80%, Placenta 86%, Uterus 89% |
| 2nd/3rd Trimester: Fluid 92%, Head 94%, Body 84%, Limbs 83%, Umbilical-cord 82%, Placenta 85%, Uterus 87% | |||
| Mean DSC (segmentation) | (No explicit numerical criterion provided, but correlation with acceptance rate indicates adequacy) | 1st Tri (Accepted): Fluid 0.96, Fetus 0.91, Umbilical-cord 0.68, Placenta 0.74, Uterus 0.93 | |
| 1st Tri (Rejected): Fluid 0.17, Fetus 0.55, Umbilical-cord 0.37, Placenta 0.33, Uterus 0.32 |
2nd/3rd Tri (Accepted): Fluid 0.78, Head 0.94, Body 0.68, Umbilical-cord 0.67, Limbs 0.66, Placenta 0.75, Uterus 0.80
2nd/3rd Tri (Rejected): Fluid 0.25, Head 0.46, Body 0.29, Umbilical-cord 0.38, Limbs 0.39, Placenta 0.32, Uterus 0.30 |
| UterineContour| Segmentation (uterus Dice-score) | Not explicitly stated as acceptance criteria | Average dice-score of uterus: 96% |
| | Segmentation (endometrium Dice-score) | Not explicitly stated as acceptance criteria | Average dice-score of endometrium: 92% |
| | 3D coronal view adaptation | Proportion of appropriateness evaluated as clinically diagnosable, with over 90% of all cases | Over 90% of all cases |
| ViewAssist | View recognition accuracy | Threshold 89% | Average recognition accuracy: 94.50% |
| | Anatomy annotation (Dice-score) | Threshold 0.8 | Average Dice-score: 0.892 |
| HeartAssist | View recognition accuracy | Threshold 89% | Average recognition accuracy: 95.00% |
| | Segmentation (Dice-score) | Threshold 0.8 | Average Dice-score: 0.876 |
| | Size measurement (Area error rate) | Not explicitly stated as acceptance criteria | 8% or less |
| | Size measurement (Angle error rate) | Not explicitly stated as acceptance criteria | 4% or less |
| | Size measurement (Circumference error rate) | Not explicitly stated as acceptance criteria | 11% or less |
| | Size measurement (Diameter error rate) | Not explicitly stated as acceptance criteria | 11% or less |
| BiometryAssist| Segmentation (Dice-score) | Threshold 0.8 | Average Dice-score: 0.928 |
| | Size measurement (Circumference error rate) | Not explicitly stated as acceptance criteria | 8% or less |
| | Size measurement (Distance error rate) | Not explicitly stated as acceptance criteria | 4% or less |
| | Size measurement (NT, NB, IT error rate)| Not explicitly stated as acceptance criteria | 1mm or less |
2. Sample size used for the test set and the data provenance
| AI Feature | Test Set Sample Size | Data Provenance |
|---|---|---|
| Live ViewAssist | 3,900 fetal ultrasound images | Mix of retrospective and prospective data collection in clinical practice from Americans and Koreans (gender: female, reproductive age; BMI 17-45.4) |
| EzVolume | 200 test volumes (100 in 1st trimester, 100 in 2nd/3rd trimester) | Mix of retrospective and prospective data collection in clinical practice from Koreans, Americans, Italians, and British (gender: female, reproductive age) |
| UterineContour | 450 sagittal uterus images (for segmentation) and 30 sagittal images (for 3D coronal view) | Mix of retrospective and prospective data collection in clinical practice from three hospitals in Korea (gender: female, reproductive age) |
| ViewAssist | 1,600 fetal ultrasound and fetal biometry images | Mix of retrospective and prospective data collection in clinical practice from two hospitals in America and Korea (gender: female, reproductive age; BMI 17-45.4) |
| HeartAssist | 440 fetal heart images | Mix of retrospective and prospective data collection in clinical practice from America and Korea (gender: female, reproductive age; BMI 17-45.4) |
| BiometryAssist | 360 fetal biometry images | Mix of retrospective and prospective data collection in clinical practice from two hospitals in America and Korea (gender: female, reproductive age; BMI 17-45.4) |
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
| AI Feature | Number of Experts | Qualifications of Experts |
|---|---|---|
| Live ViewAssist | 3 primary experts, 1 supervising expert | An obstetrician with more than 20 years of experience (primary). Two sonographers with more than 10 years of experience, all in fetal cardiology (primary). Another obstetrician with more than 25 years of experience (supervisor). |
| EzVolume | 4 primary experts, 1 supervising expert | An obstetrician with more than 20 years of experience (primary). Three examiners (clinical experts) with more than 10 years of experience, all in fetal diagnosis (primary). Another obstetrician with more than 25 years of experience (supervisor). |
| UterineContour | 3 OB/GYN experts | Three participating OB/GYN experts with more than 10 years' experience. |
| ViewAssist | 3 primary experts, 1 supervising expert | An obstetrician with more than 20 years of experience (primary). Two sonographers with more than 10 years of experience, all in fetal cardiology (primary). Another obstetrician with more than 25 years of experience (supervisor). |
| HeartAssist | 3 primary experts, 1 supervising expert | An obstetrician with more than 20 years of experience (primary). Two sonographers with more than 10 years of experience, all in fetal cardiology (primary). Another obstetrician with more than 25 years of experience (supervisor). |
| BiometryAssist | 3 primary experts, 1 supervising expert | An obstetrician with more than 20 years of experience (primary). Two sonographers with more than 10 years of experience, all in fetal cardiology (primary). Another obstetrician with more than 25 years of experience (supervisor). |
4. Adjudication method for the test set
| AI Feature | Adjudication Method |
|---|---|
| Live ViewAssist | Ground truth established by consensus of 3 experts, supervised by 1. Exact method (e.g., 2+1, 3+1) not explicitly detailed, but implied by "manual drawing" and "classified into acceptable and not-acceptable views by three participating experts." |
| EzVolume | Ground truths were drawn manually by four participating clinical experts, supervised by one. |
| UterineContour | Each of the 3 experts delineated structures. Conflicts were resolved by a consensus of the three experts ("fixed the wrong part with consensus"). |
| ViewAssist | Ground truth established by consensus of 3 experts, supervised by 1. |
| HeartAssist | Ground truth established by consensus of 3 experts, supervised by 1. |
| BiometryAssist | Ground truth established by consensus of 3 experts, supervised by 1. |
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as performed to compare human readers with and without AI assistance. The studies described focus on the standalone performance of the AI algorithms.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, standalone performance studies of the AI algorithms were done for all the described features: Live ViewAssist, EzVolume, UterineContour, ViewAssist, HeartAssist, and BiometryAssist. The reported metrics like Cohen's kappa, FPS, acceptance rates, Dice scores, and error rates are all measures of the algorithm's performance without human intervention during the assessment phase (though human experts were used to establish ground truth).
7. The type of ground truth used
For all features, the ground truth was established by expert consensus based on manual classification, delineation, or drawing by qualified clinical experts (obstetricians, sonographers, and examiners).
8. The sample size for the training set
The document explicitly states that "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap among the three." However, the exact sample size for the training set itself is not provided for any of the features. The sample sizes listed in Section 2 are for the test/validation sets.
9. How the ground truth for the training set was established
For all features, the ground truth for the training set (and validation/evaluation sets) was established through manual classification, delineation, or drawing by the same groups of qualified clinical experts mentioned in section 3, following similar expert consensus processes as described for the test sets. For UterineContour, initial delineations by 3 experts were then reviewed and fixed with consensus for unmatched results.
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(111 days)
Voluson Signature 18 / Voluson Signature 20 system are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson Signature 18 / Voluson Signature 20 system clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic: Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shearwave Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/ PWD, B/Power/PWD. The Voluson Signature 18 / Voluson Signature 20 system are intended to be used in a hospital or medical clinic.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
The provided text is a 510(k) summary for the GE Voluson Signature 20 and Signature 18 diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. It does not describe an AI/software-as-a-medical-device (SaMD) study with specific acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).
The document states: "The subject of this premarket submission, Voluson Signature 20/18 did not require clinical studies to support substantial equivalence." This indicates that no specific performance study, clinical or otherwise, was conducted to demonstrate the device meets acceptance criteria using test sets, expert ground truth, or MRMC studies that would be typical for an AI/SaMD product.
Instead, the summary emphasizes that the new device shares fundamental scientific technology with its predicate, has the same clinical intended use (with additional migrated features from other cleared devices like Shearwave Elastography, which is an imaging mode, not an AI algorithm performing diagnostic interpretation), and complies with relevant safety and performance standards for ultrasound systems.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details for an AI component from this document because it does not describe such a study. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence for an ultrasound system, focusing on safety, fundamental technology, and similar intended use.
In summary, based on the provided text, the device did not undergo the type of study described in your request for AI/SaMD products.
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