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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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(118 days)
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Power Doppier, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 20, Voluson™ Expert 22 is 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 highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
Here's a breakdown of the acceptance criteria and study details for the AI features of the Voluson Expert Series, based on the provided text:
Acceptance Criteria and Reported Device Performance
| AI Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SonoPelvic Floor | Success rate of each AI component (MHD plane alignment, LH contour, and measurements) is expected to be 70% or higher on datasets marked as "Good Image Quality." Success rate of each AI component is expected to be 60% or higher on datasets marked as "Challenging Image Quality." | The document states "The success rate of each AI component of the feature (MHD plane alignment, LH contour and measurements) is expected to be 70% or higher. On datasets that are marked as challenging in image quality measure the success rate of each AI component of the feature should be 60% or higher." This implies that the device met these criteria, as there are no reported failures or instances where these thresholds were not achieved. The summary of testing states "Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance." and then lists these as expectations. |
| SonoLyst | For SonoLystIR, sorting accuracy is higher than 80%. For SonoLystX, grading accuracy is higher than 80%. For SonoLystLive, accuracy is higher than 80%. | For SonoLystIR, the sorting accuracy is reported as "higher than 80%." For SonoLystX, the grading accuracy is reported as "higher than 80%." For SonoLystLive, the accuracy is reported as "higher than 80%." |
| FetalHS | The success rate of the 4CH view and 3VT view suggestion within cines is expected to be 70% or higher. The success rate of the suggested heart angle measurement is expected to be 80% or higher. | The document states "The success rate of the 4CH view and 3VT view suggestion within cines is expected to be 70% or higher. The success rate of the suggested heart angle measurement is expected to be 80% or higher." Similar to SonoPelvic Floor, this indicates that the device met these criteria. |
Study Details for AI Features
1. SonoPelvic Floor:
- Sample size for the test set: 110 3D/4D Volumes from 70+ individual patients.
- Data provenance: Images collected from Europe, Asia, and South Africa.
- Number of experts used to establish ground truth & qualifications: The results generated by the AI software were verified as "Pass or Fail" by a "certified sonographer/Clinician." The number of such sonographers/clinicians is not specified, but it implies at least one. Specific qualifications beyond "certified sonographer/Clinician" are not detailed.
- Adjudication method: Not explicitly stated, but the process involves a single expert verifying the AI output. There is no mention of multiple experts or a specific consensus method beyond single expert review.
- MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
- Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in generating results.
- Type of ground truth used: Expert verification by a "certified sonographer/Clinician."
- Sample size for the training set: Not specified, but it's stated that the volumes used for testing were "completely distinct from the ones used during training process and there is no overlap between the two."
- How the ground truth for the training set was established: Not specified.
2. SonoLyst:
- Sample size for the test set: 40,000+ images derived from 5,000+ exams (individual patients).
- Data provenance: Exams from the United Kingdom, Austria, India, USA. A mix of retrospective and prospective data collection from GE and non-GE scanners.
- Number of experts used to establish ground truth & qualifications:
- Initial curation (sorting and grading) by a "single Sonographer."
- Review panel of "5-sonographer[s]" for instances where SonoLyst differed from the initial ground truth, to determine sorting and grading accuracy. Qualifications beyond "sonographer" are not detailed.
- Adjudication method:
- Initial ground truth established by a single sonographer.
- Discrepancies between the AI and initial ground truth were reviewed by a "5-sonographer review panel." The sorting ground truth was reclassified based on the "majority view of the panel." This implies a form of 5-sonographer consensus, where the majority dictates the revised ground truth.
- MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
- Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in sorting and grading images.
- Type of ground truth used: Expert consensus, specifically from a panel of 5 sonographers for ambiguous cases, following initial assessment by a single sonographer.
- Sample size for the training set: Not specified, but it's stated that the exams used for testing were "separated from the ones used during training process and there is no overlap between the two."
- How the ground truth for the training set was established: Not specified.
3. FetalHS:
- Sample size for the test set: 400+ cines from 250+ patients.
- Data provenance: USA, India, Japan, Germany, Austria.
- Number of experts used to establish ground truth & qualifications: The AI software's results were verified as "Pass or Fail" by "certified sonographers/clinicians." The number of such sonographers/clinicians is not specified, but it implies at least one. Specific qualifications beyond "certified sonographers/clinicians" are not detailed.
- Adjudication method: Not explicitly stated, but the process involves a single expert verifying the AI output. There is no mention of multiple experts or specific consensus beyond single expert review.
- MRMC comparative effectiveness study: No. This was a standalone AI performance evaluation.
- Standalone (algorithm only) performance: Yes, the study evaluates the performance of the AI algorithm in suggesting views and measuring heart angles.
- Type of ground truth used: Expert verification by "certified sonographers/clinicians."
- Sample size for the training set: Not specified, but it's stated that the datasets used for testing were "completely distinct from the ones used during training process and there is no overlap between the two."
- How the ground truth for the training set was established: Not specified.
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(85 days)
The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIO P10, LOGIO P9 and LOGIO P8 clinical applications include: evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative (abdominal, vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are intended to be used in a hospital or medical clinic.
The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display.
The provided text describes a 510(k) premarket notification for the LOGIQ P10, LOGIQ P9, and LOGIQ P8 diagnostic ultrasound systems. It details the device's intended use, comparison to predicate devices, and a summary of non-clinical tests. However, the document explicitly states in "Summary of Clinical Tests" that "The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study was conducted or reported in this 510(k) submission.
The document focuses on demonstrating substantial equivalence through:
- Comparison to Predicate Devices: Showing the new devices use the same fundamental scientific technology, have the same clinical intended uses (with minor additions), similar imaging modes (with some new modes migrated from other cleared devices like UGAP), and similar capabilities for measurements, image capture, review, and reporting.
- Non-Clinical Tests: Verifying acoustic output, biocompatibility, cleaning and disinfection effectiveness, and compliance with thermal, electrical, electromagnetic, and mechanical safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA PS 3.1 - 3.20 (2016) DICOM Set, IEC 62359).
- Quality Assurance Measures: Including risk analysis, requirements reviews, design reviews, unit level testing, integration testing, performance testing, and safety testing.
There is no mention of acceptance criteria based on performance metrics that would typically arise from a clinical study (e.g., sensitivity, specificity, AUC) or any study that evaluated human reader performance with or without AI assistance, as these are not AI/ML-enabled devices described here, but rather general diagnostic ultrasound systems.
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(79 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
When Pinpoint™ GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include: Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
The LOGIQ P9; LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 74 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4 inch LCD touch screen and color 21.5 inch LCD image display.
This document is a 510(k) Premarket Notification from GE Healthcare for their LOGIQ P9 and LOGIQ P7 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo clinical study with detailed performance metrics against specific acceptance criteria. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) study for performance reporting (such as ROC curves, sensitivity/specificity, sample sizes for test/training sets, or expert ground truth adjudication) is not present.
However, based on the provided text, we can infer and extracting relevant safety and effectiveness information as follows:
1. Table of Acceptance Criteria (Inferred from Compliance and Testing) and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance and Compliance |
|---|---|
| Safety and Effectiveness (General Equivalence) | The LOGIQ P9; LOGIQ P7 systems are substantially equivalent to predicate devices with regard to intended use, imaging capabilities, technological characteristics, safety, and effectiveness. |
| Clinical Intended Uses | The LOGIQ P9; LOGIQ P7 systems have the same clinical intended uses as their predicate devices, with the addition of Transesophageal exams. The device is intended for use for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular). |
| Imaging Modes | The LOGIQ P9; LOGIQ P7 systems have the same imaging modes as their predicate devices, except for the addition of Shear wave elastography (migrated from LOGIQ S8) and enhancement of B-flow/B-flow color mode with high definition color. HDlive®, Tricefy, and LOGIQ P Apps features have also been migrated from other GE Ultrasound systems. |
| Transducer Compatibility | Transducers are identical to predicate devices, with the addition of L3-12-RS, 6Tc-RS, P2D, and IC9-RS transducers. |
| Biocompatibility | Manufactured with materials evaluated and found to be safe; transducer materials and patient contact materials are biocompatible. |
| Acoustic Output Levels | Acoustic power levels are below applicable FDA limits and conform to NEMA UD 2 (2004). |
| Electrical, Electromagnetic, and Mechanical Safety | Designed in compliance with approved electrical and physical safety standards, including AAMI/ANSI ES60601-1, IEC60601-1-2, and IEC60601-2-37. |
| Risk Management | Application of risk management to medical devices (ISO14971:2007). |
| Measurements, Digital Imaging, Reviewing, and Reporting | Similar capability to predicate devices for performing measurements, capturing digital images, reviewing, and reporting studies. Can recall non-ultrasound DICOM images. |
| Compliance with FDA Ultrasound Specific Guidance | Complies with "Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008)". |
| Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification). |
2. Sample Sizes and Data Provenance for Test Set
The document explicitly states: "The subject of this premarket submission, LOGIQ P9; LOGIQ P7, did not require clinical studies to support substantial equivalence."
This means there wasn't a separate "test set" in the context of a prospective clinical trial or performance study against pre-defined metrics. The submission relies on bench testing, compliance with standards, and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with patient data.
- Sample Size for Test Set: Not applicable as a clinical test set was not used for this 510(k) submission.
- Data Provenance: Not applicable for clinical performance data. The data provenance discussed is related to compliance with engineering standards and existing clearances for predicate and reference devices (e.g., K163596, K170445, K160162, K173555).
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- Not applicable, as a clinical test set requiring expert ground truth establishment for a performance study was not performed. The evaluation relies on technical performance and safety testing, and substantial equivalence to existing devices cleared through other means.
4. Adjudication Method for the Test Set
- Not applicable, as a clinical test set requiring adjudication was not utilized.
5. MRMC Comparative Effectiveness Study
- Not applicable. This submission is for a diagnostic ultrasound system, not an AI or imaging assistance device that would typically undergo an MRMC study to show human reader improvement with AI assistance. The focus is on the device's inherent safety and performance for imaging.
6. Standalone Performance (Algorithm Only)
- Not applicable in the context of an "algorithm only" performance typical for AI/SaMD. The device itself is an ultrasound imaging system. Its performance relates to its ability to generate diagnostic ultrasound images and fluid flow analysis, which is demonstrated through engineering and safety evaluations and comparison to predicate devices.
- While new features like "Shear wave elastography" involve processing, their performance is demonstrated via technical validation and substantial equivalence, not a standalone algorithm efficacy study in the typical AI sense.
7. Type of Ground Truth Used
- Not applicable in the sense of 'ground truth' defined by expert consensus or pathology for a clinical performance study. The "ground truth" here is compliance with established engineering and safety standards, and the capabilities of the already cleared predicate devices.
8. Sample Size for the Training Set
- Not applicable. This is a hardware/software system, and the submission does not describe a machine learning model that was "trained" on a dataset in the way an AI/SaMD product would be. The "training" here refers to the device's design and engineering based on established physics and medical imaging principles.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as no external "training set" with established ground truth was utilized for a machine learning model. The device's design and functionality are based on long-standing principles of ultrasound imaging and adherence to regulatory standards.
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